Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The primary objectives of this study are to assess bronchodilator efficacy as determined by forced expiratory volume in one second (FEV1), the effect on dyspnoea as determined by the Baseline Dyspnoea Index/Transition Dyspnoea Index (BDI/TDI), the effect on health status as determined by the St George Respiratory Questionnaire (SGRQ) and the effect on chronic obstructive pulmonary disease (COPD) exacerbations.
Interventions
DRUGTiotropium/Salmeterol QD
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
DRUGPlacebo
Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule
DRUGSalmeterol
Salmeterol Inhalation Powder, hard PE capsule
DRUGTiotropium/Salmeterol QD+ Salmeterol
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule
Tiotropium, 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 Inclusion criteria: * Diagnosis of COPD * Post-bronchodilator FEV1\<80% predicted and FEV1/FVC\<70% predicted Main
Exclusion criteria
* Significant other diseases then COPD * Recent myocardial infarction (MI) * Unstable or life-threatening arrythmia requiring intervention or change in drug therapy * Hospitalisation for cardiac failure in past year * History of asthma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trough forced expiratory volume in one second (FEV1) response | 12 Weeks, 24 Weeks and 48 Weeks |
| FEV1 area under the curve (AUC) 0-8h response | 12 Weeks, 24 Weeks and 48 Weeks |
| Mahler Transition Dyspnoea Index (TDI) focal score | 12 Weeks, 24 Weeks and 48 Weeks |
| St George Respiratory Questionnaire (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 |
|---|---|
| Individual FEV1, FVC and peak expiratory flow (PEF) measurements | 48 weeks |
| Weekly mean morning pre-dose and evening pre-dose PEFs and FEV1 (recorded by Asthma Monitor® 2 (AM2+)); PEFs determined by spirometry ] | 48 weeks |
| Weekly mean number of COPD related night time awakenings | 1 week |
| 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 |
| FEV1 AUC 0-8h 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 |
| Trough FEV1 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 |
| Forced vital capacity (FVC) AUC0-8h and trough FVC response | 48 weeks |
Countries
Austria, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, Slovakia, South Korea, Sweden, United States
Outcome results
None listed