Clinical Trial Results:
TARGETING OF THE SMALL AIRWAYS IN PATIENTS WITH COPD: AIRWAY EFFECTS OF TIOTROPIUM -Respimat vs. Handihaler
Summary
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EudraCT number |
2015-001615-13 |
Trial protocol |
GB |
Global end of trial date |
11 Jan 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Oct 2019
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First version publication date |
19 Oct 2019
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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 |
151C2697
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02683668 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Imperial College London
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Sponsor organisation address |
South Kensington Campus, London, United Kingdom, SW7 2AZ
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Public contact |
Dr Omar Usmani, Imperial College London, +44 (0)20 7351 8051, o.usmani@imperial.ac.uk
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Scientific contact |
Dr Omar Usmani, Imperial College London, +44 (0)20 7351 8051, o.usmani@imperial.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 |
07 Jan 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 Jan 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Jan 2018
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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 |
Our principle objective is to investigate the effect of tiotropium (a long-acting inhaled bronchodilator), delivered from different devices, on a panel of small (IOS, MBNW, DLCO, FVC) and large airway (FEV1, PEF) responses in patients with mild-moderate COPD. We will compare equivalent doses of Titropium from Respimat (Tiotropium Respimat 5 micrograms once daily), a small particle soft mist inhaler (SMI) compared to delivering it from Handihaler (18 micrograms once daily), a standard large particle dry powder inhaler (DPI). Respimat is a novel inhaler platform that has small particles and a slow inhalation allowing deeper lung drug delivery.
We will be using easily performed non-invasive breathing tests to measure response:
• Impulse Oscillometry (IOS) parameters
• Multiple Nitrogen Washout parameters (MBNW)
• Lung function test (LFT) parameters:
We will also assess the safety and tolerability, as determined by vital signs of heart rate and blood pressure.
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Protection of trial subjects |
None
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jun 2015
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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: 44
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Worldwide total number of subjects |
44
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EEA total number of subjects |
44
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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) |
12
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From 65 to 84 years |
32
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85 years and over |
0
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Recruitment
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Recruitment details |
Participant were recruited at Royal Brompton Hospital between February 2016 and January 2018 | ||||||||||
Pre-assignment
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Screening details |
A total of 47 participant were screened, 3 excluded due to not meet the inclusion criteria | ||||||||||
Period 1
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Period 1 title |
Phase 0
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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All participant | ||||||||||
Arm description |
All participants treated with HandiHaler 18mcg Tiotropium, no training for the participants | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Tiotropium
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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 |
18ug daily
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Period 2
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Period 2 title |
Phase 1
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Is this the baseline period? |
No | ||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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All participant | ||||||||||
Arm description |
All participant treated with HandiHaler 18ug Tiotropium daily. training provided for participants | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Tiotropium
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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 |
18ug daily
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Period 3
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Period 3 title |
phase 2
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Is this the baseline period? |
No | ||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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All participant | ||||||||||
Arm description |
All participants treated with Respimat 5mcg Tiotropium, no training for the participants | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Tiotropium
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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 |
5ug daily
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Baseline characteristics reporting groups
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Reporting group title |
Phase 0
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
All participant
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Reporting group description |
All participants treated with HandiHaler 18mcg Tiotropium, no training for the participants | ||
Reporting group title |
All participant
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Reporting group description |
All participant treated with HandiHaler 18ug Tiotropium daily. training provided for participants | ||
Reporting group title |
All participant
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Reporting group description |
All participants treated with Respimat 5mcg Tiotropium, no training for the participants |
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End point title |
R5-R20 [1] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
6 months
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical analyses ongoing, end date is January 2020. |
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No statistical analyses for this end point |
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End point title |
Sacin [2] | ||||||||||||||||
End point description |
After treatment IMPULSE Oscillometry
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End point type |
Primary
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End point timeframe |
14 days
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical analyses ongoing, end date is January 2020. |
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No statistical analyses for this end point |
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End point title |
Lung function FEV1 [3] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
14 days
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Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical analyses ongoing, end date is January 2020. |
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No statistical analyses for this end point |
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End point title |
Multi-Breath Washout Test (MBW) | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
14 days
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
3 months
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Assessment type |
Non-systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
All participant
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Reporting group description |
- | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
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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 event were detected on the trial. |
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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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09 Nov 2015 |
Modify Participant consent form, Participant information sheet (PIS). |
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01 Sep 2016 |
We request a change in one of the exclusion criteria of our study protocol. |
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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 |