A randomized, double-blind, double-dummy, parallel group trial comparing 12 weeks treatment with tiotropium inhalation capsules 18 mcg via the HandiHaler® once daily to Combivent® Inhalation Aerosol CFC MDI 2 actuations q.i.d. in COPD patients currently prescribed Combivent® Inhalation Aerosol CFC MDI - SOLSTICE II
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD) including chronic bronchitis and emphysemaMedDRA version: 8.1 Level: LLT Classification code 10010952 Term: COPD
- Registration Number
- EUCTR2006-000822-30-GB
- Lead Sponsor
- Boehringer Ingelheim Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 350
1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial.
2. Male or female patients 40 years of age or older.
3. Current or ex-smokers with a smoking history of >/= to 10 pack years. Patients who have never smoked cigarettes must be excluded.
4. Use of Combivent® Inhalation Aerosol MDI for maintenance COPD treatment at least one month prior to screening.
5. All patients must have a diagnosis of chronic obstructive pulmonary disease (re:ATS/ERS statement on COPD), relatively stable airway obstruction, and must meet the following spirometric criteria:
•At Visit 1 – post-bronchodilator FEV1 < or =70% of predicted [after administration of albuterol (salbutamol) 200 mcg]
•At Visit 2 – pre-bronchodilator FEV1< or =65% of predicted normal and FEV1/FVC =70%
Predicted normal values will be calculated according to Morris equation.
6. Ability to perform technically acceptable pulmonary function tests and able to maintain records (electronic Patient Daily Record) during the study period as required in the protocol.
7.Ability to inhale medication from the HandiHaler® and the metered dose inhaler.
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. Significant diseases other than COPD will be excluded. 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 either the results of the study or the patient’s ability to participate in the study.
2. Clinical history of asthma.
3. History of thoracotomy with pulmonary resection.
4. Regularly use daytime supplemental oxygen therapy for more than one hour per day and who in the investigator’s opinion, will be unable to abstain from the use of supplemental oxygen therapy during testing.
5. Use of systemic corticosteroids in an unstable daily dose (less than 6 weeks on a stable dose) or a daily dose of >10 mg of prednisone or its equivalent.
6. Respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial Visit 1.
7. Recent history (i.e., 6 months or less) of myocardial infarction.
8. Any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.
9. Currently undergoing radiation therapy or chemotherapy for a malignancy.
10. 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 3 months prior to and for the duration of the trial.
11. Participation in another trial with investigational drug within 30 days or 6 half lives (whichever is greater) of the start of the study.
12. Known hypersensitivity to anticholinergic drugs, soya lecithin or related food products such as soybean and peanut, lactose or any other components of the study medications or derivatives.
13. Current or recent (within 4 weeks of Visit 1) participation in a pulmonary rehabilitation program.
14. Significant alcohol or drug abuse in the previous year.
15. Use of commercially available Spiriva in the preceding 3 months.
16. Current treatment with beta-blocker medications.
17. Current treatment with oral beta-adrenergics.
18. Use of cromolyn sodium or nedocromil sodium, antileukotrienes or leukotriene receptor antagonists within 3 months of Visit 1.
19.Current treatment with monoamine oxidase inhibitors or tricyclic antidepressants.
20. Use of regularly scheduled ipratropium (Atrovent® MDI, nebulizer, or nasal solution) or other short-acting anticholinergic (i.e. oxitropium), nebulized combination of ipratropium and albuterol or other combination of anticholinergic and beta agonist in any formulation (ie:Berdual®)in the previous month.
21. Symptomatic prostatic hypertrophy or bladder neck obstruction. Patients with symptomatically controlled prostatic hypertrophy on medications may be included and should continue their medications.
23. Known narrow-angle glaucoma.
24. Current participation in another interventional study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method