Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 9.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease
Conditions
Interventions
Trade Name: Spiriva 18 microgram, inhalation powder, hard capsule
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Tiotropium bromide
Concentration unit: µg microgram(s)
Conce
Sponsors
Boehringer Ingelheim bv
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Outpatients of either sex, aged = 40 years with a diagnosis of relatively stable, moderate to severe COPD [post bronchodilator 30%= FEV1=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Recent history of MI. 2. Hospitalization for heart failure (NYHA class III or IV) within the past year. 3. Unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring an intervention or a change in drug therapy during the past year. 4. Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. 5. History of asthma, allergic rhinitis or who have a total blood eosinophil count = 600 mm3. 6. History of life-threatening pulmonary obstruction or a history of cystic fibrosis or clinically evident bronchiectasis. 7. Active tuberculosis. 8. Thoracotomy with pulmonary resection. 9. Use of daytime oxygen 10. Resent treatment with theophylline, oral betaadrenergics or systemic corticosteroids at unstable doses 11. Pregnant or nursing women or women of childbearing potential who are not practicing acceptable means of birth control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate and compare the effect on lung function parameters of the combination of salmeterol (50µg bid, Diskus) and tiotropium (18 µg capsule via Handihaler qd) and the four different treatments: a) 1000 µg fluticasone (2 puffs of 250 µg bid) ex valve b) 400 µg ciclesonide (5 puffs of 80 µg qd) ex actuator c) 800 µg ciclesonide (5 puffs of 160 µg qd) ex actuator d) or placebo at the end of 4-week periods of randomised treatment.;Secondary Objective: To evaluate and compare the effect on: 1. Trough FVC response 2. FEV1 and FVC morning peak response at day 1 and 28 3. FEV1 and FVC evening peak response at day 28 4. FEV1 AUC0-3h, FEV1 AUC12-15h, FVC AUC0-3h and FVC AUC12-15h 5. Individual FEV1 and FVC measurements 6. Trough and peak IC and VC response at day 1 and 28 7. Peak Expiratory Flow 8. Rescue therapy use 9. Mahler Dyspnea Indices 10. Fractional exhaled nitric oxide 11. Safety;Primary end point(s): The primary endpoint will be trough forced expiratory volume in one second (FEV1) response determined at the end of four week treatment periods. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline is the pre-treatment FEV1 measured just prior to first administration of the randomised treatment after the 4-week run-in period. | — |
Countries
Belgium, Denmark, Germany, Netherlands
Outcome results
None listed