Clinical Trial Results:
A Randomized, Double-blind, Placebo-controlled, Crossover Study to
Assess the Effect of 28 Day Treatment with Fostair® pMDI 200/12 on biomarkers of platelet adhesion in Patients with Idiopathic pulmonary fibrosis.
Summary
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EudraCT number |
2013-004404-19 |
Trial protocol |
GB |
Global end of trial date |
25 Apr 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Jan 2019
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First version publication date |
02 Jan 2019
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Other versions |
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Summary report(s) |
clinical study report |
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 |
Acadmed18013
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02048644 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
hull and east yorkshire nhs hosptals trust
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Sponsor organisation address |
castle hill hospital, castle rd, cottingham, United Kingdom, hu16 5jq
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Public contact |
Wright, Hull and East Yorkshire Hospitals NHS Trust , 44 1482624067, c.e.wright@hull.ac.uk
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Scientific contact |
caroline Wright, Hull and East Yorkshire Hospitals NHS Trust , 44 1482624067, c.e.wright@hull.ac.uk
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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 |
12 Dec 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
25 Apr 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
25 Apr 2015
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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 |
There is a significant unmet medical need for the treatment of Idiopathic pulmonary fibrosis (IPF); there is no effective therapy for treatment of IPF in the UK, and only pirfenidone is approved for treatment. The main goal of the current study is to evaluate the effect of Fostair on the biomarkers of platelet activation in IPF disease. We believe that platelets- cell fragments which have a major role in wound healing, also have a pivotal role in the pathogenesis of IPF and whether this translates in to a clinically beneficial effect of Fostair on IPF disease.
The primary objective of this study is to determine the effect of Fostair fine particle Metered dose inhaler on markers of pulmonary fibrosis. Primary endpoint will be a change in biomarkers of platelet activation.
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Protection of trial subjects |
continued in routine care
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Background therapy |
- | ||
Evidence for comparator |
No Comparators used | ||
Actual start date of recruitment |
03 Mar 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 |
United Kingdom: 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) |
2
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From 65 to 84 years |
18
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85 years and over |
0
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Recruitment
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Recruitment details |
Recruitment took place within the pulmonary fibrosis clinics and also from the pulmonary fibrosis support group by informing patients of the ongoing studies. recruitment began on 11/06/2014 | ||||||||||||||||||
Pre-assignment
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Screening details |
screening patirents were screened for eligibility to take part in the study main criteria were adults (40-85 years of age) with IPF diagnosis according to ATS/ERS Consensus Statement, Able to maintain O2 saturation of ≥ 89% while breathing room air at rest and a FVC (forced vital capacity) of 50-110% predicted value. | ||||||||||||||||||
Period 1
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Period 1 title |
baseline
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst | ||||||||||||||||||
Arms
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Arm title
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baseline | ||||||||||||||||||
Arm description |
no treatmentnt | ||||||||||||||||||
Arm type |
baseline | ||||||||||||||||||
Investigational medicinal product name |
no product
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Investigational medicinal product code |
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Other name |
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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 |
baseline period no products given to subjects as title suggests BASELINE PERIOD
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Period 2
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Period 2 title |
Treatment period
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Is this the baseline period? |
No | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Assessor | ||||||||||||||||||
Blinding implementation details |
BDP/Formoterol 100/6 HFA pMDI combination inhaler and matched placebo were packed and supplied by Chiesi Ltd. The inhalers were identical; ensuring both patient and investigator remained blind to the active medication being received
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Fostair | ||||||||||||||||||
Arm description |
Budesonide phosphate (BDP)/Formoterol 100/6 HFA pMDI | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
budesonide phosphate
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Investigational medicinal product code |
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Other name |
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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 |
Budesonide phosphate (BDP)/Formoterol 100/6 HFA delivered by metered dose inhaler.
2 puffs BD. total dose budesonide /day 400 mcg
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Arm title
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placebo | ||||||||||||||||||
Arm description |
matched placebo metered dose inhalers. The inhalers were identical; to the test inhalers ensuring both patient and investigator blind | ||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||
Investigational medicinal product name |
placebo
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Investigational medicinal product code |
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Other name |
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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 |
2 puffs of placebo twice a day
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Baseline characteristics reporting groups
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Reporting group title |
baseline
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Reporting group description |
no treatmentnt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
baseline
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Reporting group description |
no treatmentnt | ||
Reporting group title |
Fostair
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Reporting group description |
Budesonide phosphate (BDP)/Formoterol 100/6 HFA pMDI | ||
Reporting group title |
placebo
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Reporting group description |
matched placebo metered dose inhalers. The inhalers were identical; to the test inhalers ensuring both patient and investigator blind |
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End point title |
p SELECTIN expression | ||||||||||||||||
End point description |
Measured differences between the baseline and two treatments on AUC P-selectin expression obtained from ANOVA and Tukey post hoc test for multiple comparisons.
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End point type |
Primary
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End point timeframe |
recorded at baseline, following 4 week Fostair and following 4 week placebo inhalers with a 4week washout between therapy
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Statistical analysis title |
P-selectiin difference from baseline ANOVA | ||||||||||||||||
Statistical analysis description |
measured differences between the baseline and Fostair on AUC P-selectin expression obtained from ANOVA and Tukey post hoc test for multiple comparisons.
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Comparison groups |
baseline v Fostair
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Number of subjects included in analysis |
34
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Analysis specification |
Post-hoc
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Analysis type |
superiority [1] | ||||||||||||||||
P-value |
≤ 0.05 | ||||||||||||||||
Method |
ANOVA | ||||||||||||||||
Parameter type |
Mean difference (net) | ||||||||||||||||
Confidence interval |
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level |
95% | ||||||||||||||||
sides |
2-sided
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lower limit |
5.8 | ||||||||||||||||
upper limit |
140.6 | ||||||||||||||||
Variability estimate |
Standard deviation
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Notes [1] - ANOVA and Tukey post hoc test for multiple comparisons. |
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Statistical analysis title |
P-selectin difference from baseline with placebo | ||||||||||||||||
Statistical analysis description |
ANOVA and Tukey post hoc test for multiple comparisons.
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Comparison groups |
baseline v placebo
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Number of subjects included in analysis |
34
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Analysis specification |
Post-hoc
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Analysis type |
superiority | ||||||||||||||||
P-value |
≤ 0.05 | ||||||||||||||||
Method |
ANOVA | ||||||||||||||||
Parameter type |
Mean difference (net) | ||||||||||||||||
Confidence interval |
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level |
95% | ||||||||||||||||
sides |
2-sided
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lower limit |
-22 | ||||||||||||||||
upper limit |
141 | ||||||||||||||||
Variability estimate |
Standard deviation
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End point title |
platelet fibrinogen expression | ||||||||||||||||
End point description |
Measured differences between the baseline and two treatments on AUC platelet fibrinogen expression obtained from ANOVA and Tukey post hoc test for multiple comparisons.
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End point type |
Primary
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End point timeframe |
measured at baseline, following 4 weeks Fostair and following 4 weeks placebo with a 4 week washout between treatments
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Statistical analysis title |
Platelet fibrinogen expression Fostair | ||||||||||||||||
Statistical analysis description |
Measured differences between the baseline and Fostair treatment in AUC platelet-fibrinogen expression obtained from ANOVA and Tukey post hoc test for multiple comparisons.
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Comparison groups |
Fostair v baseline
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Number of subjects included in analysis |
34
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Analysis specification |
Post-hoc
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Analysis type |
superiority [2] | ||||||||||||||||
P-value |
≤ 0.05 | ||||||||||||||||
Method |
ANOVA | ||||||||||||||||
Parameter type |
Mean difference (net) | ||||||||||||||||
Confidence interval |
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level |
95% | ||||||||||||||||
sides |
2-sided
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lower limit |
-53 | ||||||||||||||||
upper limit |
253 | ||||||||||||||||
Variability estimate |
Standard deviation
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Notes [2] - AUC Platelet fibrinogen expression obtained from ANOVA and Tukey post hoc test for multiple comparisons. Study was a crossover study thus only 17 patients analysed |
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Statistical analysis title |
platelet fibrinogen expression with placebo | ||||||||||||||||
Statistical analysis description |
Measured differences between the baseline and placebo on AUC Platelet fibrinogen expression obtained from ANOVA and Tukey post hoc test for multiple comparisons.
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Comparison groups |
placebo v baseline
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Number of subjects included in analysis |
34
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Analysis specification |
Post-hoc
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Analysis type |
superiority [3] | ||||||||||||||||
P-value |
≤ 0.05 | ||||||||||||||||
Method |
ANOVA | ||||||||||||||||
Parameter type |
Mean difference (net) | ||||||||||||||||
Confidence interval |
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level |
95% | ||||||||||||||||
sides |
2-sided
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lower limit |
-136 | ||||||||||||||||
upper limit |
169 | ||||||||||||||||
Variability estimate |
Standard deviation
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Notes [3] - AUC P-selectin expression obtained from ANOVA and Tukey post hoc test for multiple comparisons. the study was a crossover therefore only 17 patients data analysed |
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End point title |
platelet monocyte aggregates | ||||||||||||||||
End point description |
Differences between the baseline and two treatments on AUC platelet monocyte aggregates obtained from ANOVA and Tukey post hoc test for multiple comparisons.
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End point type |
Primary
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End point timeframe |
measured at baseline, following 4 weeks Fostair and following 4 weeks placebo inhalers with a 4 week washout between treatments
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Statistical analysis title |
platelet monocyte aggregates Fostair | ||||||||||||||||
Statistical analysis description |
differences between the baseline and Fostair on AUC platelet monocyte aggregates (PMA) obtained from ANOVA and Tukey post hoc test for multiple comparisons.
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Comparison groups |
baseline v Fostair
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Number of subjects included in analysis |
34
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Analysis specification |
Post-hoc
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Analysis type |
superiority [4] | ||||||||||||||||
P-value |
≤ 0.05 | ||||||||||||||||
Method |
ANOVA | ||||||||||||||||
Parameter type |
Mean difference (net) | ||||||||||||||||
Confidence interval |
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level |
95% | ||||||||||||||||
sides |
2-sided
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lower limit |
-117 | ||||||||||||||||
upper limit |
144 | ||||||||||||||||
Variability estimate |
Standard deviation
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Notes [4] - Change from baseline AUC PMA from ANOVA and Tukey post hoc test for multiple comparisons. This was a crossover study thus 17 patients data analysed |
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Statistical analysis title |
PMA- placebo | ||||||||||||||||
Statistical analysis description |
Differences between the baseline and placebo AUC PMA obtained from ANOVA and Tukey post hoc test for multiple comparisons.
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Comparison groups |
baseline v placebo
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Number of subjects included in analysis |
34
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Analysis specification |
Post-hoc
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Analysis type |
superiority [5] | ||||||||||||||||
P-value |
≤ 0.05 | ||||||||||||||||
Method |
ANOVA | ||||||||||||||||
Parameter type |
Mean difference (net) | ||||||||||||||||
Confidence interval |
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level |
95% | ||||||||||||||||
sides |
2-sided
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lower limit |
-168 | ||||||||||||||||
upper limit |
92.4 | ||||||||||||||||
Variability estimate |
Standard deviation
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Notes [5] - ANOVA and Tukey post hoc test for multiple comparisons. This was a crossover study thus 17 patients data analysed |
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End point title |
Forced expired volume in 1 second | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
from baseline through to post 4 weeks foster and post 4 weeks placebo.
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Notes [6] - FAS [7] - FAS [8] - FAS |
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Statistical analysis title |
Paired test | ||||||||||||||||
Comparison groups |
baseline v Fostair v placebo
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Number of subjects included in analysis |
51
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
≤ 0.05 | ||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||
Confidence interval |
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End point title |
Forced vital capacity | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
measurement taken at baseline, at 4weeks post foster therapy, and at 4 weeks post placebo therapy. Each subject acted as own control, crossover study
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Statistical analysis title |
paired ttest | ||||||||||||||||
Statistical analysis description |
change from baseline in FVC following 4 weeks placebo was compared with change in FVC from baseline following 4 weeks fostair
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Comparison groups |
baseline v Fostair v placebo
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Number of subjects included in analysis |
51
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
≤ 0.05 | ||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||
Confidence interval |
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End point title |
FEF25-75 | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
measured at baseline, at 4weeks post placebo and at 4weeks post fostair therapy
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Statistical analysis title |
paired ttest | ||||||||||||||||
Statistical analysis description |
compared change from baseline in FEF 25/75 with placebo with that of change in from baseline following fostair. crossover study
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Comparison groups |
baseline v Fostair v placebo
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Number of subjects included in analysis |
51
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
≤ 0.05 | ||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||
Confidence interval |
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End point title |
FENO | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Measured at baseline, following 4 weeks placebo and following 4 weeks treatment with fostair with 4 week interval between treatments
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Notes [9] - Only 12 patients were able to produce sputum at all relevant visits through out study as per protoco |
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Statistical analysis title |
ANOVA | ||||||||||||||||
Statistical analysis description |
compared change from baseline between fostair and placebo
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Comparison groups |
baseline v Fostair v placebo
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Number of subjects included in analysis |
36
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Analysis specification |
Pre-specified
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Analysis type |
superiority [10] | ||||||||||||||||
P-value |
≤ 0.05 [11] | ||||||||||||||||
Method |
ANOVA | ||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||
Confidence interval |
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Notes [10] - compared baseline placebo and fostair with bonferoni. within group comparison as each individual acted as own control. only 12 subjects analysed [11] - a value<0.05 demonstrated significant difference |
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End point title |
fev1/FVC | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
measured at baseline and at 4weeks post placebo and at 4 weeks post fostair with a 4 week interval between treatments.
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Statistical analysis title |
ANOVA | ||||||||||||||||
Comparison groups |
baseline v Fostair v placebo
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Number of subjects included in analysis |
51
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Analysis specification |
Post-hoc
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Analysis type |
superiority | ||||||||||||||||
P-value |
≤ 0.05 | ||||||||||||||||
Method |
ANOVA | ||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||
Confidence interval |
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End point title |
KBILD | ||||||||||||||||
End point description |
measuring total score for Kings Brief questionnaire for interstitial lung disease
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End point type |
Secondary
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End point timeframe |
measured at baseline, following 4 weeks placebo and following 4 weeks fostair
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Notes [12] - not parallel study crossover on 17 analysed |
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Statistical analysis title |
ANOVA | ||||||||||||||||
Comparison groups |
baseline v Fostair v placebo
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Number of subjects included in analysis |
51
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Analysis specification |
Post-hoc
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Analysis type |
superiority | ||||||||||||||||
P-value |
≤ 0.05 | ||||||||||||||||
Method |
ANOVA | ||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events were reported at baseline, following 4 weeks treatment with placebo at the end of the 4 week interval (no therapy) and at the end of the 4 week treatment with fostair.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
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Reporting groups
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Reporting group title |
Full analysis set
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Reporting group description |
full analysis set | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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02 Jul 2014 |
1)Prohibited mediciation:- Irreversible cyclo-oxygenase inhibitors- Aspirin. To remove this class of medications from the list
2)Inclusion critera: 4. FVC of 50-80% predicted. To change this criteria to FVC of 50-110% predicted. |
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21 Nov 2014 |
1) Extension of certificate of analysis on the fostair/placebo inhalers
2) Supply of 20 additional kits with expiry increased to April 2015. |
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/2925571 |