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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
465
To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler
To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler
To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler
Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 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.
Time frame: Baseline and 12 weeks
Trough FEV1 Response Determined After a Treatment Period of 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.
Time frame: Baseline and 12 weeks
Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 12-week Treatment Period.
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.
Time frame: Baseline and 12 weeks
FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 12-week Treatment Period.
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.
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205.442.54002 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
205.442.54005 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
205.442.54003 Boehringer Ingelheim Investigational Site
San Juan Bautista, Argentina
205.442.43002 Boehringer Ingelheim Investigational Site
Linz, Austria
205.442.43003 Boehringer Ingelheim Investigational Site
Schlüsslberg, Austria
205.442.43001 Boehringer Ingelheim Investigational Site
Wels, Austria
205.442.38502 Boehringer Ingelheim Investigational Site
Rijeka, Croatia
205.442.38501 Boehringer Ingelheim Investigational Site
Split, Croatia
205.442.38503 Boehringer Ingelheim Investigational Site
Split, Croatia
205.442.38504 Boehringer Ingelheim Investigational Site
Zagreb, Croatia
...and 52 more locations
Time frame: Baseline and 12 weeks
FVC (AUC0-3h) Response at the End of the 12-week Treatment Period.
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.
Time frame: Baseline and 12 weeks
Asthma Control Questionnaire (ACQ) Responder After 12 Weeks of Treatment
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 frame: 12 weeks
Time to First Severe Asthma Exacerbation During the 12-week Treatment.
Severe asthma exacerbations are defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days.
Time frame: 12 weeks
Time to First Asthma Exacerbation During the 12-week Treatment.
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.
Time frame: 12 weeks
Use of Rescue Medication During 24h Period
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.
Time frame: Baseline and 12 weeks
Use of Rescue Medication During Daytime
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.
Time frame: Baseline and 12 weeks
Use of Rescue Medication During Nighttime
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.
Time frame: Baseline and 12 weeks