Clinical Trial Results:
A Single-Centre, Open-Label, Randomised, 2-Way Cross-Over Study to Determine the Effects on the
Short-Term Lower Leg Growth Rate Between Qvar® 100 Mcg BD Delivered via a Metered Dose Inhaler (MDI) (TEVA UK Ltd) With a Reference Beclometasone Formulation via a Reference MDI in Children with Mild to Moderate Asthma
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Summary
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EudraCT number |
2007-007455-14 |
Trial protocol |
DK |
Global end of trial date |
27 Dec 2008
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Jan 2019
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First version publication date |
05 Jan 2019
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
QV-001/2007-Pae
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Teva UK Ltd
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Sponsor organisation address |
Building V, Harlow Campus, London Road, Harlow, United Kingdom, CM17 9LP
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Public contact |
Director, Clinical Research, Teva Branded Pharmaceutical Products, R&D Inc, 001 2155913000, info.eraclinical@teva.de
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Scientific contact |
Director, Clinical Research, Teva Branded Pharmaceutical Products, R&D Inc, 001 2155913000, info.eraclinical@teva.de
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 Dec 2008
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Dec 2008
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To demonstrate non-inferiority of Qvar 100 micrograms (mcg) twice daily (BD) relative to a reference formulation, Beclazone 200 mcg BD, in terms of the short-term growth rate of the right lower leg, measured by knemometry, in children with documented mild to moderate asthma.
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Protection of trial subjects |
This study was conducted in compliance to the study protocol, and in accordance with the provisions of the guidelines of the World Medical Association Declaration of Helsinki in its revised edition (Tokyo, Japan, 2004), the guidelines of lnternational Conference on Harmonisation (ICH) Good Clinical Practice (GCP) (CPMP/ICH/135/95) and "Clinical Investigation of Medicinal Products in the Paediatric Population" (CPMP/ICH/2711/99), designated Standard Operating Procedures (SOPs), and with local laws and regulations relevant to the use of new and/or further development of therapeutic agents in the country of conduct. This study was also conducted in compliance with European Union (EU) Regulation 1901/2006. The study was conducted with due attention to the rights of children.Written consent to participate in the study was given by all participants' parents/guardian prior to any study procedures being performed and after they had read an Information Sheet about the study, and received a verbal explanation by the Investigator or his study nurses (who all had paedagogical skills) about the nature of the study, its purpose, procedures, expected duration and benefits, the necessity of having both parents consent and all examinations and treatment, sprays and spacers included in the study and risks of participation. The written consent obtained also included permission for the investigator to contact the participants' General Practitioner for details of previous medical history.
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Background therapy |
Participants were allowed to take short-acting beta agonist (SABA) therapy throughout the study (during 2-week run-in period, 2-week wash-out period, and both treatment periods [2 weeks each]). | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
08 Sep 2008
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 64
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Worldwide total number of subjects |
64
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EEA total number of subjects |
64
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
64
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||
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Pre-assignment
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Screening details |
This study was conducted at single centre in Denmark. After screening and 2-week run-in period, a total of 64 participants were randomized and treated in this study. | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Sequence 1: Qvar Then Beclazone | ||||||||||||||||||
Arm description |
Participants received Qvar (Beclometasone dipropionate) 100 mcg BD in first treatment period (Week 0 to Week 2) and Beclazone (Beclometasone dipropionate/Clorofluorocarbon [CFC] formulation) 200 mcg BD in second treatment period (Week 4 to Week 6). There was a 2-week washout period (Week 2 to Week 4) between both treatment periods. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Qvar
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Investigational medicinal product code |
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Other name |
Beclometasone dipropionate
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Pharmaceutical forms |
Pressurised inhalation
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Routes of administration |
Inhalation use
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Dosage and administration details |
Qvar was administered via pressurised metered dose inhaler (pMDI) (Qvar® IVAX with an AeroChamber® spacer) containing 200 doses of 50 mcg.
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Investigational medicinal product name |
Beclazone
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Investigational medicinal product code |
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Other name |
Beclometasone dipropionate/CFC formulation
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Pharmaceutical forms |
Pressurised inhalation
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Routes of administration |
Inhalation use
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Dosage and administration details |
Beclazone was administered via pMDI (with a Volumatic™ spacer) containing 200 doses of 100 mcg.
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Arm title
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Sequence 2: Beclazone Then Qvar | ||||||||||||||||||
Arm description |
Participants received Beclazone 200 mcg BD in first treatment period (Week 0 to Week 2) and Qvar 100 mcg BD in second treatment period (Week 4 to Week 6). There was a 2-week washout period (Week 2 to Week 4) between both treatment periods. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Qvar
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Investigational medicinal product code |
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Other name |
Beclometasone dipropionate
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Pharmaceutical forms |
Pressurised inhalation
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Routes of administration |
Inhalation use
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Dosage and administration details |
Qvar was administered via pMDI (Qvar® IVAX with an AeroChamber® spacer) containing 200 doses of 50 mcg.
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Investigational medicinal product name |
Beclazone
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Investigational medicinal product code |
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Other name |
Beclometasone dipropionate/CFC formulation
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Pharmaceutical forms |
Pressurised inhalation
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Routes of administration |
Inhalation use
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Dosage and administration details |
Beclazone was administered via pMDI (with a Volumatic™ spacer) containing 200 doses of 100 mcg.
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Baseline characteristics reporting groups
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Reporting group title |
Sequence 1: Qvar Then Beclazone
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Reporting group description |
Participants received Qvar (Beclometasone dipropionate) 100 mcg BD in first treatment period (Week 0 to Week 2) and Beclazone (Beclometasone dipropionate/Clorofluorocarbon [CFC] formulation) 200 mcg BD in second treatment period (Week 4 to Week 6). There was a 2-week washout period (Week 2 to Week 4) between both treatment periods. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Sequence 2: Beclazone Then Qvar
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Reporting group description |
Participants received Beclazone 200 mcg BD in first treatment period (Week 0 to Week 2) and Qvar 100 mcg BD in second treatment period (Week 4 to Week 6). There was a 2-week washout period (Week 2 to Week 4) between both treatment periods. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Sequence 1: Qvar Then Beclazone
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Reporting group description |
Participants received Qvar (Beclometasone dipropionate) 100 mcg BD in first treatment period (Week 0 to Week 2) and Beclazone (Beclometasone dipropionate/Clorofluorocarbon [CFC] formulation) 200 mcg BD in second treatment period (Week 4 to Week 6). There was a 2-week washout period (Week 2 to Week 4) between both treatment periods. | ||
Reporting group title |
Sequence 2: Beclazone Then Qvar
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Reporting group description |
Participants received Beclazone 200 mcg BD in first treatment period (Week 0 to Week 2) and Qvar 100 mcg BD in second treatment period (Week 4 to Week 6). There was a 2-week washout period (Week 2 to Week 4) between both treatment periods. | ||
Subject analysis set title |
Qvar
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Participants received Qvar 100 mcg BD either in first treatment period (Week 0 to Week 2) or in second treatment period (Week 4 to Week 6).
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Subject analysis set title |
Beclazone
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Participants received Beclazone 200 mcg BD either in first treatment period (Week 0 to Week 2) or in second treatment period (Week 4 to Week 6).
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Subject analysis set title |
Run-in
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Participants were only allowed to take SABA therapy as required during 2-week run-in period.
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Subject analysis set title |
Qvar
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Participants received Qvar 100 mcg BD either in first treatment period (Week 0 to Week 2) or in second treatment period (Week 4 to Week 6).
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Subject analysis set title |
Beclazone
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Participants received Beclazone 200 mcg BD either in first treatment period (Week 0 to Week 2) or in second treatment period (Week 4 to Week 6).
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End point title |
Short-Term Lower Leg Growth Rate (LLGR) During the Two Active Treatments | ||||||||||||
End point description |
Short-term LLGR was measured by knemometry of the right lower leg after 2 weeks of treatment, and was calculated for each participant and for each treatment period in millimetres per week (mm/week). Four measurements were taken at each visit, with summaries and analysis based on the mean of the last three results. The LLGR was then determined from the change in growth measurement and number of days in each period, i.e. LLGR (mm/week) = ([length in mm {end} - length in mm {start}]/[date {end} - date {start}] + 1) * 7.
Analysis was performed on intent-to treat (ITT) population included all randomised participants who received at least one administration of one of the treatments and with an available evaluation of the primary variable in at least one of the treatment periods.
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End point type |
Primary
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End point timeframe |
Treatments periods (Week 0 to Week 2; and Week 4 to Week 6)
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Statistical analysis title |
Qvar versus Beclazone | ||||||||||||
Statistical analysis description |
Actual number of participants analysed=63. Analysis was performed using a linear mixed effects model- period and treatment was included as fixed effects, participant was included as a random effect, lower leg length at the start of the interval was added as a covariate.
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Comparison groups |
Qvar v Beclazone
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Number of subjects included in analysis |
126
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [1] | ||||||||||||
Method |
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Parameter type |
Least Square (LS) Mean Difference | ||||||||||||
Point estimate |
0.03
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.03 | ||||||||||||
upper limit |
0.1 | ||||||||||||
| Notes [1] - The residual variance from the model was used to calculate lower limit of the 2 sided 95% confidence interval (CI) for the mean difference. Non-inferiority was concluded if lower limit of the 2 sided 95% CI was greater than -0.12 mm/week. |
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End point title |
LLGR During Each of the Two Active Treatments Compared With LLGR During Run-in | ||||||||||||||||
End point description |
Short-term LLGR was measured by knemometry of the right lower leg, and was calculated for each participant and for run-in period and each treatment period in mm/week. Four measurements were taken at each visit, with summaries and analysis based on the mean of the last three results. The LLGR was then determined from the change in growth measurement and number of days in each period, i.e. LLGR (mm/week) = ([length in mm {end} - length in mm {start}]/[date {end} - date {start}] + 1) * 7.
Analysis was performed on ITT population included all randomised participants who received at least one administration of one of the treatments and with an available evaluation of the primary variable in at least one of the treatment periods.
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End point type |
Secondary
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End point timeframe |
Run-in period (Week -2 to Week 0), Treatment periods (Week 0 to Week 2; and Week 4 to Week 6)
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
24-Hour Urine Free Cortisol/Creatinine Levels During the Two Active Treatments | ||||||||||||
End point description |
Participants collected 24-hour urine at the end of each treatment period. Urine samples were analysed for free cortisol and creatinine at a central laboratory. Mean cortisol (nanomole [nmol])/creatinine (millimole [mmol]) ratio was reported. Analysis was performed on ITT population included all randomised participants who received at least one administration of one of the treatments and with an available evaluation of the primary variable in at least one of the treatment periods. Here, 'Number of subjects analyzed' signifies participants who were evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Treatments periods (Week 0 to Week 2; and Week 4 to Week 6)
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| No statistical analyses for this end point | |||||||||||||
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End point title |
24-Hour Urine Free Cortisol/Creatinine Levels During Each of the Two Active Treatments Compared With Run-in Levels | ||||||||||||||||
End point description |
Participants collected 24-hour urine at the end of run-in period and each treatment period. Urine samples were analysed for free cortisol and creatinine at a central laboratory. Mean cortisol (nmol)/creatinine (mmol) ratio was reported. Analysis was performed on ITT population included all randomised participants who received at least one administration of one of the treatments and with an available evaluation of the primary variable in at least one of the treatment periods. Here, 'Number of subjects analyzed' signifies participants who were evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Run-in period (Week -2 to Week 0), Treatment periods (Week 0 to Week 2; and Week 4 to Week 6)
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Percentage of Days With Rescue Medication | ||||||||||||||||
End point description |
Participants were instructed to use the provided SABA (e.g. salbutamol) as needed during the run-in, treatment and washout periods. The daily use of rescue medication (number of SABA puffs) was recorded by the participants on their diary cards twice daily in the morning and in the evening. The number of puffs taken during the night was recorded on the diary card each morning on awakening while the number of puffs taken during the day was recorded each evening before taking the study drug. The percentage of days rescue medication taken was calculated as: (Number of days with puffs greater than [>] 0/Number of days in period) * 100. For the calculation of percentages, days with missing results were assumed as a day with rescue medication. Analysis was performed on ITT population included all randomised participants who received at least one administration of one of the treatments and with an available evaluation of the primary variable in at least one of the treatment periods.
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End point type |
Secondary
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End point timeframe |
Week -2 to Week 6
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Average Number of Puffs Taken Per Day | ||||||||||||||||
End point description |
Participants were instructed to use the provided SABA (e.g. salbutamol) as needed during the run-in, treatment and washout periods. The daily use of rescue medication (number of SABA puffs) was recorded by the participants on their diary cards twice daily in the morning and in the evening. The number of puffs taken during the night was recorded on the diary card each morning on awakening while the number of puffs taken during the day was recorded each evening before taking the study drug. The average number of puffs per day was calculated as: Total number of puffs in period/Total number of days in period. For the calculation of percentages, days with missing results were assumed as a day with rescue medication. Analysis was performed on ITT population included all randomised participants who received at least one administration of one of the treatments and with an available evaluation of the primary variable in at least one of the treatment periods.
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End point type |
Secondary
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End point timeframe |
Week -2 to Week 6
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Change From Run-in (Week -2) in Peak Expiratory Flow (PEF) at the End of Treatment (Week 6) | ||||||||||||||||||
End point description |
PEF was measured by participants at home using a portable, hand-held peak flow meter. During each measurement session (in the morning, before the intake of the study medication) the participant performed 3 blows and the best out of three PEF parameter results was recorded by the participant or their parents/guardians as necessary on the daily diary card. Participants recorded their best AM and PM PEF result (Liters per minute [L/min]) in the diary cards. Average AM and PM PEF were calculated using all available results in each period. Analysis was performed on ITT population included all randomised participants who received at least one administration of one of the treatments and with an available evaluation of the primary variable in at least one of the treatment periods. Here, 'n' signifies participants analyzed for this endpoint for specified categories.
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End point type |
Secondary
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End point timeframe |
Week -2, Week 6
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Including Asthma Exacerbations) | |||||||||||||||
End point description |
AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-emergent AEs were AEs that commenced after exposure to study treatment. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module. Analysis was performed on safety population included all randomised participants who received at least one dose of study medication.
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End point type |
Secondary
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End point timeframe |
Treatments periods (Week 0 to Week 2; and Week 4 to Week 6)
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| No statistical analyses for this end point | ||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Treatments periods (Week 0 to Week 2; and Week 4 to Week 6)
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Adverse event reporting additional description |
Safety population included all randomised participants who received at least one dose of study medication.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
11.0
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Reporting groups
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Reporting group title |
Beclazone
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Reporting group description |
Participants received Beclazone 200 mcg BD either in first treatment period (Week 0 to Week 2) or in second treatment period (Week 4 to Week 6). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Qvar
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Reporting group description |
Participants received Qvar 100 mcg BD either in first treatment period (Week 0 to Week 2) or in second treatment period (Week 4 to Week 6). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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10 Jun 2008 |
- Amendments to the text of study procedures, Visit 1 screening in response to the request by the Danish Ethics committee. - Amendments to the text of following sections were made in response to the request by the Danish Medicines Agency: Lung function measurements with spirometer, recording and reporting AEs, protocol synopsis visit schedule- protocol synopsis, study design, randomization and blinding, primary variable. - Amendments to the text of following sections were made at the request of the Investigator following review of Danish translation by email: Protocol synopsis, inclusion criteria, exclusion criteria, treatment, primary objective, selection and withdrawal of participants. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
