EUCTR2009-015713-51-ATActive, not recruitingNot Applicable
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®. - TIOSPIR
Boehringer Ingelheim RCV GmbH & Co KG0 sites16,800 target enrollmentStarted: May 3, 2010Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 16,800
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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®
- •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
- •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
- •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®
- •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
- •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
- •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
- •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
- •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
- •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.
- •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
- •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.
- +22 more not shown
Investigators
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