To compare the efficacy and safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution delivered by the Respimat® Inhaler with Tiotropium inhalation capsules 18 µg delivered by the HandiHaler®.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints:
- Time to death (all-cause mortality)
- Time to first COPD exacerbation
Secondary outcome
Secondary endpoints:
- Number of COPD exacerbations
- Time to first hospitalisation due to COPD exacerbation
- Number of hospitalisations due to COPD exacerbations
- Time to first major adverse cardiovascular event
Background summary
Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5
µg formulations have been limited to 4-week crossover studies. Therefore,
prospective data from a trial of adequate size and duration is required to
establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will
have (a) similar effects on safety and (b) similar or superior effects on
exacerbations.
Study objective
To compare the efficacy and safety of 2.5 µg and 5 µg Tiotropium Inhalation
Solution delivered by the Respimat® Inhaler with Tiotropium inhalation capsules
18 µg delivered by the HandiHaler®.
Study design
A randomised, active-controlled, double-blind, double-dummy, parallel group
design, multi-center trial
Intervention
Eligible patients are assigned to one of the three double-blind treatments at
Visit 1 ( 2,5 mcg or 5 mcg tiotropium inhalation solution, administered with
the Respimat® Inhaler, or tiotropium inhalation capsules 18 mcg, administered
via the HandiHaler®. The treatment for each patient is determined by random
assignment.
Study burden and risks
Patients are requested to visit the clinic about every 3 months over a maximum
period of 3 years.
Visit 2: physical ex (basal), ECG, vital signs, pulmonary function testing
(FVC/FEV1) only if there are no results available of a PFT performed < 6 months
ago; prenancy test (if applicable, visit 1 and end of treatment visit),
explanation about study medication inhalation (all clinic visits). Patients are
requested to document all changes to (COPD) medication and new or changed
symptoms at home in a reminder card.
Comeniusstraat 6
1817 MS Alkmaar
NL
Comeniusstraat 6
1817 MS Alkmaar
NL
Listed location countries
Age
Inclusion criteria
1.All patients must sign an informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
2.Male or female patients 40 years of age or older.
3.Patients must be current or ex-smokers with a smoking history of >=10 pack-years.
4.All patients must have a diagnosis of COPD (according to definition in protocol page 26)
5.Patients must be able to inhale from the HandiHaler® and the Respimat® devices.
Exclusion criteria
1.Significant diseases other than COPD. (see protocl for definitions)
2.Patients with a recent history (i.e., six months or less) of myocardial infarction.
3.Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
4.Hospitalisation for cardiac failure (New York Heart Association (NYHA) Class III or IV) during the past year.
5. A respiratory infection or exacerbation of COPD in the four weeks prior to screening.
6. Patients with a history of asthma, cystic fibrosis, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease
7. Use of systemic corticosteroid medication at unstable doses (i.e., less than six weeks on stable dose) or at doses in excess of the equivalent of 10 milligrams (mg) prednisolone per day
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-015713-51-NL |
| CCMO | NL31791.060.10 |