Clinical Trial Results:
A single (assessor) - blind, randomised, three-period, cross-over study to compare the safety of flutiform® pMDI, fluticasone pMDI and beclometasone Autohaler® in paediatric subjects aged 5 to less than 12 years with mild persistent asthma by means of knemometry.
Summary
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EudraCT number |
2013-004719-32 |
Trial protocol |
DK |
Global end of trial date |
13 Jun 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Feb 2016
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First version publication date |
03 Jul 2015
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Other versions |
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 |
FLT2504
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02063139 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Mundipharma Research Ltd.
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Sponsor organisation address |
Cambridge Science Park, Milton Road, Cambridge, United Kingdom, CB4 0GW
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Public contact |
European Medical Operations, Mundipharma Research Ltd, 0044 1223 424900, info@contact-clinical-trails.com
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Scientific contact |
European Medical Operations, Mundipharma Research Ltd, 0044 1223 424900, info@contact-clinical-trails.com
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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 |
13 Jun 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 Jun 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Jun 2014
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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 show non-inferiority of flutiform pMDI 50/5 µg (2 puffs bid) versus fluticasone pMDI 50 µg (2 puffs bid) based on the mean lower leg growth rates.
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Protection of trial subjects |
Over the course of the study there were 3 periods of 2 weeks each (the run-in and 2 washout periods) during which subjects were not treated with inhaled corticosteroids (but were able to use salbutamol rescue medication). To minimise the risk to subjects during these periods, only children with mild asthma treated with a short acting beta agonist (SABA) alone or non-ICS controller were enrolled such that the risk of not administering inhaled corticosteroids during the run-in / washout periods was low. Regarding the ethics of conducting a growth suppressive study, the total treatment-related growth inhibition during this short-term trial would have been expected to be less than 1 millimetre. Furthermore this inhibition would cease on discontinuation of the study treatment and no long-term residual impacts on growth would be expected.
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Background therapy |
Salbutamol Airomir® Autohaler® rescue medication (breath actuated inhaler) was used in the run in, wash-out and treatment periods, as required, up to four occasions per day (2 puffs on each occasion). If a subject required rescue medication on more than 4 occasions on any day they were to contact the Investigator. | ||
Evidence for comparator |
Flixotide Evohaler was chosen as the primary comparator as it contains the same ICS component as Flutiform and represents the same pharmaceutical form (a pressurised metered dose inhaler). The benefit:risk of Flixotide in paediatric asthma is long established hence this product is an appropriate comparator against which to gauge the safety of the ICS component of Flutiform. Both products were used in conjunction with a spacer device, which is consistent with the GINA recommendation to use a pMDI in conjunction with a spacer as a first line device option in paediatric asthma. A third treatment arm, Aerobec Autohaler (also known as QVAR Autohaler), containing the ICS Beclometasone, was included in the study for exploratory purposes to evaluate potential differences in suppressive effects between different ICS / device combinations and to serve as a positive control. The Autohaler is a breath-actuated pressurised metered dose inhaler approved for use in children aged 5 and above in Denmark and multiple other EU member states. | ||
Actual start date of recruitment |
24 Feb 2014
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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: 48
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Worldwide total number of subjects |
48
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EEA total number of subjects |
48
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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) |
48
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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 |
All 48 subjects were randomised in one site in Denmark between 10 Mar 2014 and 27 Mar 2014. | ||||||||||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 48 subjects provided written informed consent and were screened and, as no subjects failed screening, all 48 subjects were randomised into the study. Two subjects discontinued early from the study due to subject’s choice. | ||||||||||||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Period
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | ||||||||||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Assessor [1] | ||||||||||||||||||||||||||||||||||||||||||||||||
Blinding implementation details |
The assessor undertaking lower leg measurements via knemometry was blinded to study treatment (the “assessing” investigator). A different “treating” investigator was responsible for supervising study treatment.The subject and treating investigator were open to the treatment being taken during each treatment period. The study team, including persons involved in conducting the analysis of the study, remained blinded to the treatments patients were randomised to until after study database lock.
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Flutiform | ||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Flutiform
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Investigational medicinal product code |
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Other name |
Fluticasone/ formoterol
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Pharmaceutical forms |
Inhalation powder
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Routes of administration |
Inhalation use
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Dosage and administration details |
50/5 µg, 2 puffs, Q12h
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Arm title
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Fluticasone | ||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Flixotide
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Investigational medicinal product code |
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Other name |
Fluticasone propionate
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Pharmaceutical forms |
Inhalation powder
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Routes of administration |
Inhalation use
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Dosage and administration details |
50 µg, 2 puffs, Q12h
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Arm title
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Beclometasone | ||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Beclometasone
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Investigational medicinal product code |
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Other name |
QVAR
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Pharmaceutical forms |
Inhalation powder
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Routes of administration |
Inhalation use
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Dosage and administration details |
50 µg, 2 puffs, Q12h
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Notes [1] - The roles blinded appear inconsistent with a simple blinded trial. Justification: The investigator and patient were un-blinded. The Assessor taking the measurements was blinded and therefore the single blinded description. The system does not allow us to enter this without giving the warning. |
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Baseline characteristics reporting groups
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Reporting group title |
Overall Period
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Randomised Population
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Subject analysis set type |
Intention-to-treat | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All subjects who were randomised to a treatment sequence.
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Subject analysis set title |
Full Analysis Population
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Subject analysis set type |
Full analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All randomised subjects who received at least one dose of investigational medicinal product (IMP) and had a valid baseline and at least one valid post-baseline lower leg growth rate value
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Subject analysis set title |
Per Protocol Population
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Subject analysis set type |
Per protocol | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All overall Full Analysis Population subjects without major protocol deviations.
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Subject analysis set title |
Safety Population
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Subject analysis set type |
Safety analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The safety population was defined as all randomised subjects who received at least one dose of study medication (IMP).
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End points reporting groups
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Reporting group title |
Flutiform
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Reporting group description |
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Reporting group title |
Fluticasone
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Reporting group description |
- | ||
Reporting group title |
Beclometasone
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Reporting group description |
- | ||
Subject analysis set title |
Randomised Population
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
All subjects who were randomised to a treatment sequence.
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Subject analysis set title |
Full Analysis Population
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All randomised subjects who received at least one dose of investigational medicinal product (IMP) and had a valid baseline and at least one valid post-baseline lower leg growth rate value
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Subject analysis set title |
Per Protocol Population
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
All overall Full Analysis Population subjects without major protocol deviations.
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Subject analysis set title |
Safety Population
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The safety population was defined as all randomised subjects who received at least one dose of study medication (IMP).
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End point title |
Difference in mean lower leg growth rate (LLGR) between Flutiform and Fluticasone treatments [1] | ||||||||||||
End point description |
Measurement of lower leg growth (LLG) using the knemometer was taken at each visit by an assessor who was blinded to the study treatment. Knemometry measurements at visits 1 to 7 were taken at the same time (+/- 1 hour) on the same day of the week whenever possible, corresponding to the beginning and the end of each treatment or wash-out period. For each subject LLG in each period (run-in, treatment, washout) was calculated as the change in LLL during the respective period. The primary analysis was based on LLG in treatment period.
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End point type |
Primary
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End point timeframe |
Each Treatment Phase was 14 days, separated by 14 days for the wash-out period.
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Notes [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Each endpoint listed compares 2 out of the 3 arms in the baseline period. The 3 endpoints include reporting statistics for all 3 arms. |
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Statistical analysis title |
Non-inferiority of Flutiform versus Fluticasone | ||||||||||||
Statistical analysis description |
The null hypothesis was: -0.2 > µFlutiform - µfluticasone
The mean lower leg growth rate during treatment (mm/week) was analysed using an Analysis of Covariance (ANCOVA) model, with fixed terms for treatment, period, treatment sequence, baseline lower leg growth rate and FEV1% predicted value at baseline and subject within sequence as a random effect.
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Comparison groups |
Flutiform v Fluticasone
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Number of subjects included in analysis |
60
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [2] | ||||||||||||
P-value |
< 0.001 [3] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-0.006
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.095 | ||||||||||||
upper limit |
0.084 | ||||||||||||
Notes [2] - A non-inferiority margin of -0.2mm/week was used, based on an estimated placebo growth rate of 0.4mm/week, the observation, that 25 to 50% reduction in short-term lower leg growth rate translates to a reduction in medium term growth rate of between 0.5 to 1.5cm/year, and considering the technical error margin of 0.1mm associated with knemometry. The intended power for the test of non-inferiority of Flutiform versus Fluticasone was set to 90%. [3] - The null hypothesis was tested with a one-sided significance level of 0.025 (being equivalent to a two-sided test at a 0.05 level of significance). |
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End point title |
Difference in mean lower leg growth rate (LLGR) between Flutiform and Beclometasone treatments [4] | ||||||||||||
End point description |
Measurement of lower leg growth using the knemometer was taken at each visit by an assessor who was blinded to the study treatment. Knemometry measurements at visits 1 to 7 were taken at the same time (+/- 1 hour) on the same day of the week whenever possible, corresponding to the beginning and the end of each treatment or wash-out period. For each subject LLG in each period (run-in, treatment, washout) was calculated as the change in LLL during the respective period. The primary analysis was based on LLG in treatment period.
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End point type |
Primary
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End point timeframe |
Each Treatment Phase was 14 days, separated by 14 days for the wash-out period.
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Notes [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Each endpoint listed compares 2 out of the 3 arms in the baseline period. The 3 endpoints include reporting statistics for all 3 arms. |
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Statistical analysis title |
Superiority of Flutiform versus Beclometasone | ||||||||||||
Statistical analysis description |
The null hypothesis was that the difference in means is 0 mm/week
The mean lower leg growth rate during treatment (mm/week) was analysed using an Analysis of Covariance (ANCOVA) model, with fixed terms for treatment, period, treatment sequence, baseline growth rate and FEV1% predicted value at baseline and subject within sequence as a random effect.
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Comparison groups |
Flutiform v Beclometasone
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Number of subjects included in analysis |
56
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Analysis specification |
Pre-specified
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Analysis type |
superiority [5] | ||||||||||||
P-value |
= 0.057 [6] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.116
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.004 | ||||||||||||
upper limit |
0.235 | ||||||||||||
Notes [5] - A difference of 0 mm/week was used. [6] - 2-sided p-value of treatment comparison based on the null hypothesis that the difference in means is 0 mm/week. |
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End point title |
Difference in mean lower leg growth rate (LLGR) between Fluticasone and Beclometasone treatments [7] | ||||||||||||
End point description |
Measurement of lower leg growth using the knemometer was taken at each visit by an assessor who was blinded to the study treatment. Knemometry measurements at visits 1 to 7 were taken at the same time (+/- 1 hour) on the same day of the week whenever possible, corresponding to the beginning and the end of each treatment or wash-out period. For each subject LLG in each period (run-in, treatment, washout) was calculated as the change in LLL during the respective period. The primary analysis was based on LLG in treatment period.
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End point type |
Primary
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End point timeframe |
Each Treatment Phase was 14 days, separated by 14 days for the wash-out period.
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Notes [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Each endpoint listed compares 2 out of the 3 arms in the baseline period. The 3 endpoints include reporting statistics for all 3 arms. |
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Statistical analysis title |
Superiorty of Fluticasone versus Beclometasone | ||||||||||||
Statistical analysis description |
The null hypothesis was that the difference in means is 0 mm/week.
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Comparison groups |
Beclometasone v Fluticasone
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Number of subjects included in analysis |
68
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Analysis specification |
Pre-specified
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Analysis type |
superiority [8] | ||||||||||||
P-value |
< 0.001 [9] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.163
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
0.078 | ||||||||||||
upper limit |
0.249 | ||||||||||||
Notes [8] - The mean lower leg growth rate during treatment (mm/week) was analysed using an Analysis of Covariance (ANCOVA) model, with fixed terms for treatment, period, treatment sequence, baseline lower leg growth rate and FEV1% predicted value at baseline and subject within sequence as a random effect. [9] - 2-sided p-value of treatment comparison based on the null hypothesis that the difference in means is 0 mm/week. |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse Events (AEs) were recorded from the point at which the Informed Consent was signed until 7 days after the subject left the study. This included new AEs that were reported in the 7 days following the subject’s completion/discontinuation visit.
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Adverse event reporting additional description |
Any AE that was still ongoing 7 days after the completion/discontinuation visit had an outcome of ‘ongoing’ in the CRF; SAEs were followed until the event resolved or the event or sequelae stabilized. A treatment emergent AE was defined as any AE with an onset date on or after the first dose of IMP, or worsened after the first dose of IMP.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.0
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Reporting groups
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Reporting group title |
Flutiform
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Fluticasone
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Beclometasone
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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? No | |||
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 |