A randomised, active-controlled, double-blind, double-dummy, parallel group design, multi-center trial to compare the efficacy and safety of 2.5 microgram and 5 microgram Tiotropium Inhalation Solution delivered by the Respimat Inhaler with Tiotropium inhalation capsules 18 microgram delivered by the HandiHaler - ND

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 9.1Level: LLTClassification code 10009033

• Registration Number: EUCTR2009-015713-51-IT
• Lead Sponsor: BOEHRINGER ING.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-13
• Last Update Posted: 30 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 21000

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. (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%. Pulmonary function tests to be conducted after the inhalation of 400 micrograms salbutamol / albuterol (preferred). Testing with either 200 micrograms salbutamol/albuterol or a combination of salbutamol/albuterol with ipratropium bromide (2 to 4 actuations) is acceptable. Furthermore historical data from measurements within the past 6 months either at the site or at a referral site may be used. If the measurements are not performed at the trial site a referral letter and signed copies of the measurement printouts must be provided to the trial site for source data verification. In case several qualifying spirometry measurements are available, the most recent one should be referred to as long as it was not performed during an exacerbation. Patients may not be randomised to the study without the availability of spirometry data at the actual study site. 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. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence the patients ability to participate in the study. 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. Patients with a history of thoracotomy for other reasons should be evaluated as per Exclusion 1. 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 (i.e., less than six weeks on stable dose) or at doses in excess of the equivalent of 10 milligrams (mg) prednisolone per day 16. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm or subdermal implants e.g., Norplant) for at least three months prior to and for the duration of the trial. 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