Clinical Trial Results:
Blod and urine concentrations of Procaterol in persons with asthma and elite athletes with asthma: a comparison of inhalation vs. oral administration.
Summary
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EudraCT number |
2010-023346-78 |
Trial protocol |
DK |
Global end of trial date |
01 Jan 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Feb 2017
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First version publication date |
09 Feb 2017
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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 |
PROCAL2010
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Bispebjerg University Hospital
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Sponsor organisation address |
Bispebjerg Bakke 23, Copenhagen, Denmark, 2400
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Public contact |
Respiratory Research Unit, Bispebjerg Hospital, mhostrup@nexs.ku.dk
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Scientific contact |
Respiratory Research Unit, Bispebjerg Hospital, mhostrup@nexs.ku.dk
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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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
06 Mar 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Jan 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Jan 2016
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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 investigate the pharmacokinetic and pharmakodynamic properties of inhaled vs oral administered procaterol in healthy young men, asthmatics and elite athletes with astma.
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Protection of trial subjects |
Safety of the trial subjects was high prioritized. All procedures are well tolerated and at risk periods, the subjects were under surveillance so that a member of staff could intervene if needed. The study was performed under the GCP-guidelines.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jun 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
20
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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) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
20
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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 |
Recruitment started on the 1st of june 2011 and ended on the 15thof december 2012 Recruitment took place in Denmark, mostly in the Greater Copenhagen Area | |||||||||
Pre-assignment
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Screening details |
# Doctors examination # ECG and pulmonary function testing # Incremental test | |||||||||
Pre-assignment period milestones
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Number of subjects started |
20 | |||||||||
Number of subjects completed |
20 | |||||||||
Period 1
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Period 1 title |
Intervention (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Healthy | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Procaterol
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for nebuliser solution, Tablet
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Routes of administration |
Oral use, Not mentioned
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Dosage and administration details |
4 µg procaterol was administered as nebulization
100 µg procaterol was administered orally.
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Arm title
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Asthmatic | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Procaterol
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for nebuliser solution, Tablet
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Routes of administration |
Not mentioned , Oral use
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Dosage and administration details |
4 µg procaterol was administered as nebulization
100 µg procaterol was administered orally.
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End points reporting groups
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Reporting group title |
Healthy
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Reporting group description |
- | ||
Reporting group title |
Asthmatic
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Reporting group description |
- |
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End point title |
Urine concentrations | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
During whole trial
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Statistical analysis title |
Repeated-measures analysis | ||||||||||||
Comparison groups |
Healthy v Asthmatic
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Number of subjects included in analysis |
20
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
P-value |
≤ 0.05 | ||||||||||||
Method |
ANOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Confidence interval |
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level |
95% | ||||||||||||
sides |
1-sided
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lower limit |
- | ||||||||||||
upper limit |
- | ||||||||||||
Variability estimate |
Standard deviation
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Adverse events information [1]
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Timeframe for reporting adverse events |
From inclusion until 1 week post end of trial
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Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
National Authority | ||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
Procaterol
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Reporting group description |
- | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||
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Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No adverse events have been reported. |
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/26990656 |