Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo and Salmeterol HydroFluoroAlkane (HFA) Metered Dose Inhaler (MDI) (50 mcg Twice Daily) in Patient With Moderate Persistent Asthma II
- Conditions
- Asthma
- Interventions
- Drug: placeboDrug: 50 mcg salmeterol HFA MDI
- Registration Number
- NCT01172821
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily). Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of maintenance treatment with inhaled corticosteroid controller medication in patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on quality of life, effects on asthma control, effects on health care resource utilisation, and number of adverse events.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1032
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tiotropium low dose tiotropium Respimat® low dose Once daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily) tiotropium high dose tiotropium Respimat® high dose Once daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily) tiotropium high dose placebo Once daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily) 50 mcg salmeterol placebo Twice daily, delivered with HFA MDI (+ inhalation of placebo Respimat® inhaler once daily) 50 mcg salmeterol 50 mcg salmeterol HFA MDI Twice daily, delivered with HFA MDI (+ inhalation of placebo Respimat® inhaler once daily) placebo placebo Once daily, delivered with Respimat® inhaler + twice daily delivered with HFA MDI tiotropium low dose placebo Once daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily)
- Primary Outcome Measures
Name Time Method Peak FEV1 Within 3 Hours Post-dose Response 24 weeks Peak forced expiratory volume in one second (FEV1) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.
Trough FEV1 Response 24 weeks Trough FEV1 response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.
The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821) 24 weeks The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period (on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.
- Secondary Outcome Measures
Name Time Method Peak FVC Within 3 Hours Post-dose Response 24 weeks Peak forced vital capacity (FVC) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.
Trough FVC Response 24 weeks Trough FVC response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.
FEV1 Area Under Curve 0-3 Hours (AUC0-3h) Response 24 weeks Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24- week treatment. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
FVC Area Under Curve 0-3 Hours (AUC0-3h) Response 24 weeks Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24- week treatment. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
Trough PEF Response 24 weeks Trough peak expiratory flow (PEF) response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.
Total Asthma Quality of Life Questionnaire (AQLQs)) Score 24 weeks Total score from the Standardised Asthma Quality of Life Questionnaire (AQLQ(s)) determined at the end of 24-week treatment.
The AQLQ(s) contains 32 questions, each question has a 7 point scale from 1 (highest intensity) till 7 (no symptoms). Total score was defined as the sum of all items divided by the number of items and ranges from from 1 (highest intensity) till 7 (no symptoms). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.Total Asthma Control Questionnaire (ACQ) Score 24 weeks Control of asthma as assessed by the ACQ determined at the end of 24-week treatment. The ACQ contains 7 questions, each question has a 7 point scale from 0 (no symptoms) till 6 (highest intensity). Total score was defined as the sum of all items divided by the number of items and ranges from from 0 (no symptoms) till 6 (highest intensity). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.
The Responder Rate as Assessed by the ACQ 24 weeks The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period. A patient was considered to be a responder if he or she was reported with an improvement (decrease) in ACQ total score of at least 0.5 points.The score ranges from 0 (no impairment) to 6 (maximum impairment).
Mean Pre-dose Morning PEF (PEF a.m.) Based on the Weekly Mean Response at Week 24 Baseline and last 7 days before week 24 visit Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week
Mean Pre-dose Evening PEF (PEF p.m.) Based on the Weekly Mean Response at Week 24 Baseline and last 7 days before week 24 visit Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.
PEF Variability Last 7 days before week 24 visit PEF daily variability was assesed by patients at home using the AM3 device. PEF variability is the absolute difference between morning and evening PEF value divided by their mean, based on the weekly mean response at week 24. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.
Mean Pre-dose Morning FEV1 (FEV1 a.m.) Based on the Weekly Mean Response at Week 24 Baseline and last 7 days before week 24 visit Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.
Mean Pre-dose Evening FEV1 (FEV1 p.m.) Based on the Weekly Mean Response at Week 24 Baseline and last 7 days before week 24 visit Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.
Mean Number of Puffs of Rescue Medication During the Entire 24-h Day Based on the Weekly Mean Response at Week 24 Baseline and last 7 days before week 24 visit Daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.
Asthma Symptom-free Days Based on the Weekly Mean Response at Week 24 Baseline and last 7 days before week 24 visit Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. An asthma symptom-free day was defined as a day with no reported symptoms and no use of rescue medication.
Time to First Severe Asthma Exacerbation From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821) 24 weeks Time to first severe asthma exacerbation during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)
Time to First Asthma Exacerbation From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821) 24 weeks Time to first asthma exacerbation (including severe, non-severe; symptomatic, asymptomatic; i.e. any exacerbation) during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)
Trial Locations
- Locations (125)
205.419.01058 Boehringer Ingelheim Investigational Site
🇺🇸Los Angeles, California, United States
205.419.01053 Boehringer Ingelheim Investigational Site
🇺🇸Stockton, California, United States
205.419.01061 Boehringer Ingelheim Investigational Site
🇺🇸Centennial, Colorado, United States
205.419.01066 Boehringer Ingelheim Investigational Site
🇺🇸Denver, Colorado, United States
205.419.01064 Boehringer Ingelheim Investigational Site
🇺🇸Panama City, Florida, United States
205.419.01060 Boehringer Ingelheim Investigational Site
🇺🇸Winter Park, Florida, United States
205.419.01068 Boehringer Ingelheim Investigational Site
🇺🇸Novi, Michigan, United States
205.419.01054 Boehringer Ingelheim Investigational Site
🇺🇸Plymouth, Minnesota, United States
205.419.01062 Boehringer Ingelheim Investigational Site
🇺🇸St. Louis, Missouri, United States
205.419.01070 Boehringer Ingelheim Investigational Site
🇺🇸Bozeman, Montana, United States
Scroll for more (115 remaining)205.419.01058 Boehringer Ingelheim Investigational Site🇺🇸Los Angeles, California, United States