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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
220
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule
Salmeterol Inhalation Powder, hard PE capsule
Trough forced expiratory volume in one second (FEV1) response
Time frame: 12 Weeks, 24 Weeks and 48 Weeks
FEV1 area under the curve (AUC) 0-8h response
Time frame: 12 Weeks, 24 Weeks and 48 Weeks
Mahler Transition Dyspnoea Index (TDI) focal score
Time frame: 12 Weeks, 24 Weeks and 48 Weeks
St George Respiratory Questionnaire (SGRQ) total score
Time frame: 12 Weeks, 24 Weeks and 48 Weeks
Time to first moderate to severe COPD exacerbation
Time frame: 12 Weeks, 24 Weeks and 48 Weeks
FEV1 AUC 0-8h response
Time frame: 4, 36 and 48 weeks
Trough FEV1 response
Time frame: 4, 36 and 48 weeks
Peak FEV1 response
Time frame: 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)
Time frame: 24 hours
Forced vital capacity (FVC) AUC0-8h and trough FVC response
Time frame: 48 weeks
Individual FEV1, FVC and peak expiratory flow (PEF) measurements
Time frame: 48 weeks
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Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule
Tiotropium, Spiriva®
1184.14.01013 Boehringer Ingelheim Investigational Site
Boulder, Colorado, United States
1184.14.01018 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
1184.14.01006 Boehringer Ingelheim Investigational Site
Winter Park, Florida, United States
1184.14.01003 Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho, United States
1184.14.01015 Boehringer Ingelheim Investigational Site
South Bend, Indiana, United States
1184.14.01007 Boehringer Ingelheim Investigational Site
Lafayette, Louisiana, United States
1184.14.01005 Boehringer Ingelheim Investigational Site
Bangor, Maine, United States
1184.14.01020 Boehringer Ingelheim Investigational Site
Edina, Minnesota, United States
1184.14.01009 Boehringer Ingelheim Investigational Site
Burlington, North Carolina, United States
1184.14.01002 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
...and 62 more locations
Weekly mean morning pre-dose and evening pre-dose PEFs and FEV1 (recorded by Asthma Monitor® 2 (AM2+)); PEFs determined by spirometry ]
Time frame: 48 weeks
Weekly mean number of COPD related night time awakenings
Time frame: 1 week
Mahler TDI focal score
Time frame: 4, 36 and 48 weeks
Mahler Dyspnoea Indices (Functional Impairment, Magnitude of Task and Magnitude of Effort)
Time frame: 4, 12, 24, 36 and 48 weeks
SGRQ total score, and the impact, activity and symptoms domain scores from the SGRQ
Time frame: 4, 12, 36 and 48 weeks
All adverse events
Time frame: 48 weeks
Vital signs: pulse rate and blood pressure
Time frame: Baseline and 4 weeks
Routine blood chemistry, haematology and urinalysis
Time frame: Baseline and 48 weeks
Vital status of randomised patients
Time frame: 48 weeks
Number of days in hospital (including ambulance transportation
Time frame: 48 weeks
Number of unscheduled health care provider visits
Time frame: 48 weeks
Number of visits in emergency room (including ambulance transportation)
Time frame: 48 weeks
Number of days in intensive care unit
Time frame: 48 weeks
Concomitant medications (for instance antibiotics and systemic steroids).
Time frame: 48 weeks