Efficacy and Safety of 2 Doses of Tiotropium Via Respimat in Adult Patients With Mild Persistent Asthma
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT01316380
- 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 compared to placebo over 12 week treatment period. Tiotropium inhalation solution will be delivered via Respimat inhaler and will be examined on top of maintenance inhaled corticosteroid treatment in patients with mild persistent asthma. Efficacy and safety will be assessed by measuring the effects on lung functions, effects on lung exacerbations, effects on asthma control and numbers of adverse events.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 465
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tiotropium 5 mcg tiotropium 5 mcg once daily delivered via Respimat inhaler tiotropium 2.5 mcg tiotropium 2.5 mcg once daily delivered via Respimat inhaler placebo placebo once daily delivered via Respimat inhaler
- Primary Outcome Measures
Name Time Method Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 12 Weeks. Baseline and 12 weeks Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 12 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.
- Secondary Outcome Measures
Name Time Method Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 12-week Treatment Period. Baseline and 12 weeks Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 12 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.
FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 12-week Treatment Period. Baseline and 12 weeks The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 12 weeks. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit baseline\*visit.
FVC (AUC0-3h) Response at the End of the 12-week Treatment Period. Baseline and 12 weeks The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 12 weeks. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit baseline\*visit.
Asthma Control Questionnaire (ACQ) Responder After 12 Weeks of Treatment 12 weeks For the ACQ, the total score was calculated as the mean of the responses to 6 self administered questions and one question which was completed by clinical staff based upon pre-bronchodilator FEV1. The score ranges from 0 (no impairment) to 6 (maximum impairment). Response was categorised as: responder (change from baseline \<= -0.5), no change (-0.5 \<change from baseline \< 0.5) and worsening (change from baseline \>= 0.5).
Time to First Severe Asthma Exacerbation During the 12-week Treatment. 12 weeks Severe asthma exacerbations are defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days.
Time to First Asthma Exacerbation During the 12-week Treatment. 12 weeks An asthma exacerbation was defined as an episode of progressive increase in 1 or more asthma symptom that were outside the patient's usual range of day-to-day asthma symptoms and lasted for at least 2 consecutive days or as a decrease in a patient's best morning PEF of 30% or more from a patient's mean morning PEF for at least 2 consecutive days that may or may not have been accompanied by symptoms.
Trough FEV1 Response Determined After a Treatment Period of 12 Weeks. Baseline and 12 weeks The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 12 weeks and the trough FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.
Use of Rescue Medication During 24h Period Baseline and 12 weeks Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during 24 h period), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5.
The mean was adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.Use of Rescue Medication During Daytime Baseline and 12 weeks Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during daytime), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5.
The mean was adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.Use of Rescue Medication During Nighttime Baseline and 12 weeks Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during nighttime), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5.
The mean was adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.
Trial Locations
- Locations (62)
205.442.54003 Boehringer Ingelheim Investigational Site
🇦🇷Florencio Varela, Argentina
205.442.50203 Boehringer Ingelheim Investigational Site
🇬🇹Guatemala, Guatemala
205.442.54002 Boehringer Ingelheim Investigational Site
🇦🇷Capital Federal, Argentina
205.442.91011 Boehringer Ingelheim Investigational Site
🇮🇳Ahmedabad, India
205.442.82001 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
205.442.37101 Boehringer Ingelheim Investigational Site
🇱🇻Baldone, Latvia
205.442.48003 Boehringer Ingelheim Investigational Site
🇵🇱Gizycko, Poland
205.442.42101 Boehringer Ingelheim Investigational Site
🇸🇰Nove Zamky, Slovakia
205.442.48001 Boehringer Ingelheim Investigational Site
🇵🇱Poznan, Poland
205.442.39006 Boehringer Ingelheim Investigational Site
🇮🇹Cagliari, Italy
205.442.39003 Boehringer Ingelheim Investigational Site
🇮🇹Chieti, Italy
205.442.39001 Boehringer Ingelheim Investigational Site
🇮🇹Pisa, Italy
205.442.54005 Boehringer Ingelheim Investigational Site
🇦🇷Capital Federal, Argentina
205.442.36002 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡ºGödöllö, Hungary
205.442.36004 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡ºKomarom, Hungary
205.442.36005 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡ºSzazhalombatta, Hungary
205.442.91009 Boehringer Ingelheim Investigational Site
🇮🇳Banglore, India
205.442.43003 Boehringer Ingelheim Investigational Site
🇦🇹Schlüsslberg, Austria
205.442.37203 Boehringer Ingelheim Investigational Site
🇪🇪Kohtla-Järve, Estonia
205.442.43001 Boehringer Ingelheim Investigational Site
🇦🇹Wels, Austria
205.442.43002 Boehringer Ingelheim Investigational Site
🇦🇹Linz, Austria
205.442.38504 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡·Zagreb, Croatia
205.442.38503 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡·Split, Croatia
205.442.38502 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡·Rijeka, Croatia
205.442.50201 Boehringer Ingelheim Investigational Site
🇬🇹Nivel Guatemala, Guatemala
205.442.37202 Boehringer Ingelheim Investigational Site
🇪🇪Tartu, Estonia
205.442.50204 Boehringer Ingelheim Investigational Site
🇬🇹Guatemala, Guatemala
205.442.36003 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡ºCegled, Hungary
205.442.36007 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡ºBudapest, Hungary
205.442.50205 Boehringer Ingelheim Investigational Site
🇬🇹Vila hermosa I, Guatemala
205.442.36006 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡ºPecs, Hungary
205.442.36001 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡ºSzarvas, Hungary
205.442.91002 Boehringer Ingelheim Investigational Site
🇮🇳Coimbatore, India
205.442.91003 Boehringer Ingelheim Investigational Site
🇮🇳Coimbatore, India
205.442.91007 Boehringer Ingelheim Investigational Site
🇮🇳Jaipur, India
205.442.91008 Boehringer Ingelheim Investigational Site
🇮🇳Hyderabad, India
205.442.91004 Boehringer Ingelheim Investigational Site
🇮🇳Coimbatore, India
205.442.91001 Boehringer Ingelheim Investigational Site
🇮🇳Nagpur, India
205.442.91006 Boehringer Ingelheim Investigational Site
🇮🇳Pune, India
205.442.39007 Boehringer Ingelheim Investigational Site
🇮🇹Acquaviva delle Fonti (BA), Italy
205.442.82006 Boehringer Ingelheim Investigational Site
🇰🇷Cheongju-si, Korea, Republic of
205.442.82002 Boehringer Ingelheim Investigational Site
🇰🇷Gangwon-do, Korea, Republic of
205.442.82003 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
205.442.37102 Boehringer Ingelheim Investigational Site
🇱🇻Talsi, Latvia
205.442.37104 Boehringer Ingelheim Investigational Site
🇱🇻Daugavpils, Latvia
205.442.82005 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
205.442.37103 Boehringer Ingelheim Investigational Site
🇱🇻Daugavpils, Latvia
205.442.82004 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
205.442.48002 Boehringer Ingelheim Investigational Site
🇵🇱Gorzow Wielkopolski, Poland
205.442.48005 Boehringer Ingelheim Investigational Site
🇵🇱Krakow, Poland
205.442.48004 Boehringer Ingelheim Investigational Site
🇵🇱Ostrow Wielkopolska, Poland
205.442.42107 Boehringer Ingelheim Investigational Site
🇸🇰Humenne, Slovakia
205.442.42103 Boehringer Ingelheim Investigational Site
🇸🇰Topolcany, Slovakia
205.442.42105 Boehringer Ingelheim Investigational Site
🇸🇰Bardejov, Slovakia
205.442.42104 Boehringer Ingelheim Investigational Site
🇸🇰Kosice, Slovakia
205.442.42102 Boehringer Ingelheim Investigational Site
🇸🇰Nitra, Slovakia
205.442.38501 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡·Split, Croatia
205.442.37201 Boehringer Ingelheim Investigational Site
🇪🇪Rakvere, Estonia
205.442.91005 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
205.442.42106 Boehringer Ingelheim Investigational Site
🇸🇰Spisska Nova Ves, Slovakia
205.442.42108 Boehringer Ingelheim Investigational Site
🇸🇰Poprad, Slovakia
205.442.50202 Boehringer Ingelheim Investigational Site
🇬🇹Nivel Guatemala, Guatemala