Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The primary objectives of this study are to assess bronchodilator efficacy as determined by FEV1, the effect on dyspnoea as determined by the BDI/TDI, the effect on health status as determined bt the SGRQ and the effect on COPD exacerbations
Interventions
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
DRUGTiotropium/Salmeterol QD + Salmeterol
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule
DRUGPlacebo
Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule
DRUGSalmeterol
Salmeterol Inhalation Powder, hard PE capsule
DRUGTiotropium
Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main: Diagnosis of COPD Post-bronchodilator FEV1\<80% predicted and FEV1/FVC\<70% predicted
Exclusion criteria
Main: Significant other diseases then COPD Recent MI Any unstable or life-threatening cardiac arrythmia requiring intervention or change in drug therapy during the past year Hospitalisation for cardiac failure during the past year History of asthma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trough FEV1 response | 12 Weeks, 24 Weeks and 48 Weeks |
| FEV1AUC 0 8hr response | 12 Weeks, 24 Weeks and 48 Weeks |
| Mahler TDI focal score | 12 Weeks, 24 Weeks and 48 Weeks |
| SGRQ total score | 12 Weeks, 24 Weeks and 48 Weeks |
| Time to first moderate to severe COPD exacerbation | 12 Weeks, 24 Weeks and 48 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| FVC (forced vital capacity) AUC0-8h and trough FVC response | 48 weeks |
| Individual FEV1, FVC and PEF measurements | 48 weeks |
| Weekly mean morning pre-dose and evening pre-dose PEFs (peak expiratory flow) and FEV1 (recorded by AM2+); PEFs determined by spirometry ] | 48 weeks |
| Mahler TDI focal score | 4, 36 and 48 weeks |
| Mahler Dyspnoea Indices (Functional Impairment, Magnitude of Task and Magnitude of Effort) | 4, 12, 24, 36 and 48 weeks |
| SGRQ total score, and the impact, activity and symptoms domain scores from the SGRQ | 4, 12, 36 and 48 weeks |
| All adverse events | 48 weeks |
| Trough FEV1 response | 4, 36 and 48 weeks |
| Routine blood chemistry, haematology and urinalysis | Baseline and 48 weeks |
| Vital status of randomised patients | 48 weeks |
| Number of days in hospital (including ambulance transportation | 48 weeks |
| Number of unscheduled health care provider visits | 48 weeks |
| Number of visits in emergency room (including ambulance transportation) | 48 weeks |
| Number of days in intensive care unit | 48 weeks |
| Concomitant medications (for instance antibiotics and systemic steroids) | 48 weeks |
| Vital signs: pulse rate and blood pressure | Baseline and 4 weeks |
| FEV1 AUC0-8h response | 4, 36 and 48 weeks |
| Peak FEV1 response | 12, 24, 36 and 48 weeks |
| Use of rescue medication (weekly mean number of puffs of as-needed salbutamol/albuterol per day, daytime and night-time) | 24 hours |
| Weekly mean number of COPD related night time awakenings | 1 week |
Countries
Austria, Canada, Denmark, Estonia, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, Netherlands, Slovakia, South Africa, South Korea, Sweden, United States
Outcome results
None listed