A randomized, active-controlled, double-blind, double-dummy, parallel group design, multi-center trial 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®.

Phase 1

• Conditions: Chronic obstructive pulmonary disease (COPD); MedDRA version: 12.1Level: LLTClassification code 10009033Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2009-015713-51-BE
• Lead Sponsor: SCS Boehringer Ingelheim Comm.V

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-08
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16800

Inclusion Criteria

1. All patients must sign an informed consent consistent with ICH-GCP guidelines
prior to participation in the trial, includes medication washout and restrictions.

2. Male or female patients aged 40 years of age or over

3. Patients must be current or ex-smokers with a smoking history of =10 pack-
years. (Patients who have never smoked cigarettes must be excluded)

4. All patients must have a diagnosis of COPD and must meet the following
criteria:
Relatively stable airway obstruction with a post-bronchodilator FEV1 =70% of
predicted normal and post-bronchodilator FEV1 / FVC =70%

5. Patients must be able to inhale from the HandiHaler® and the Respimat®
devices.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Significant diseases other than COPD.

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. Known active tuberculosis.

6. Patients with a history of asthma, cystic fibrosis, bronchiectasis, interstitial lung
disease, or pulmonary thromboembolic disease

7. A history of thoracotomy with pulmonary resection.

8. Patients planning to undergo lung transplant or lung volume reduction surgery
(LVRS).

9. Malignancy for which the patient has undergone resection, radiation,
chemotherapy or biological treatments within the last five years. Patients with
treated basal cell carcinoma are allowed.

10. A respiratory infection or exacerbation of COPD in the four weeks prior to
screening.

11. Known hypersensitivity to anticholinergic drugs, lactose, benzalkonium
chloride (BAC), ethylenediaminetetraacetic acid (EDTA) or any other
components of the HandiHaler® or Respimat® inhalation solution delivery
system.

12. Patients with known moderate to severe renal impairment (as judged by the
investigator).

13. Patients with known narrow angle glaucoma.

14. Patients with significant symptomatic prostatic hyperplasia or bladder-neck
obstruction. Patients whose symptoms are controlled on treatment may be
included.

15. Use of systemic corticosteroid medication at unstable doses.

16. Pregnant or nursing women or women of childbearing potential not using a
medically approved means of contraception.

17. Significant alcohol or drug abuse within the past 12 months.

18. Patients requiring the use of supplemental oxygen therapy for >12 hours per
day

19. Patients who have completed a pulmonary rehabilitation program in the six
weeks prior to the screening visit or patients who are currently in a
pulmonary rehabilitation program that will not be maintained throughout the
duration of the study.

20. Patients who have taken an investigational drug within 30 days prior to
Screening Visit.

21. Previous participation (receipt of randomised treatment) in this study.

22. Patients who are currently participating in an interventional study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy and safety of 2.5mcg and 5mcg Tiotropium Inhalation Solution delivered by the Respimat Inhaler with Tiotropium inhalation capsules 18mcg delivered by the HandiHaler.;Secondary Objective: NA;Primary end point(s): The first primary endpoint is time to all-cause mortality.<br><br>The second primary endpoint is time to first COPD exacerbation. <br><br>A COPD exacerbation is defined as a complex of lower respiratory events / symptoms (increase or new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment.