A Six-week Study Comparing the Efficacy and Safety of Tiotropium Plus Formoterol to Salmeterol Plus Fluticasone in Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the efficacy and safety of tiotropium plus formoterol in comparison to salmeterol plus fluticasone in COPD patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Fluticasone; Formoterol Fumarate; Salmeterol Xinafoate; Tiotropium Bromide; Xhance

Criteria

Inclusion Criteria:

1. All patients must sign an informed consent prior to participation in the trial, which includes medication washout and restrictions.

2. All patients must have a diagnosis of chronic obstructive pulmonary disease according to the GOLD criteria and must meet the following spirometric criteria:

a post-bronchodilator FEV1 < 80% of predicted normal, a post-bronchodilator FEV1/FVC < 70% at Visit 1, and a morning FEV1 <= 65% predicted at Visit 2.

3. Male or female patients 40 years of age or older.

4. Patients must be current or ex-smokers with a smoking history of more than 10 pack-years.

5. Patients must be able to perform technically acceptable pulmonary function tests.

6. Patients must be able to inhale medication in a competent manner from the HandiHaler® device, the Blue Inhaler device, and from a metered dose inhaler (MDI).

Exclusion Criteria:

1. Patients with significant diseases other than COPD.

2. Patients with a recent history (i.e., six months or less) of myocardial infarction.

3. Patients who have been hospitalized for heart failure (NYHA class III or IV) within the past year.

4. Any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.

5. Patients with a history of cancer within the last five years.

6. Patients with known narrow-angle glaucoma.

7. Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count >= 600/mm3.

8. Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.

9. Patients with known active tuberculosis.

10. Patients with significant alcohol or drug abuse within the past two years.

11. Patients who have undergone thoracotomy with pulmonary resection.

12. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the study.

13. Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy.

14. Patients who are being treated with antihistamines (H1 receptor antagonists) for asthma or excluded allergic conditions.

15. Patients who have taken an investigational drug within one month or six half lives prior to Visit 1.

16. Patients who have been treated with oral beta-adrenergics within one month prior to Visit 1.

17. Patients who have been treated with antileukotrienes or leukotriene receptor antagonists for any disease within one month prior to Visit 1.

18. Patients who have been treated with oral steroids within six weeks prior to Visit 1.

19. Patients who have been treated with monoamine oxidase inhibitors or tricyclic antidepressants within one month prior to Visit 1.

20. Patients who have been treated with cromolyn sodium or nedocromil sodium within one month prior to Visit 1.

21. Patients who have been treated with inhaled steroids within two months prior to Visit 1, including combinations of inhaled steroids and long-acting beta-adrenergics.

22. Patients with known hypersensitivity to anticholinergic drugs, beta adrenergics, lactose or any other components of the inhalation capsule delivery system or any other components of the aerosol delivery systems.

23. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception for the previous three months.

24. Patients with any respiratory infections in the six weeks prior to the Screening Visit (Visit 1) or during the run-in period.

25. Patients who are currently participating in another study.

26. Patients requiring more than eight puffs of salbutamol on three or more consecutive days during the run-in period.