Efficacy and Safety of 2 Doses of Tiotropium Respimat Compared to Placebo in Adolescents With Severe Persistent Asthma
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT01277523
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily) over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma.
The primary objective of the trial is to demonstrate superiority of tiotropium (5 mcg and possibly 2.5 mcg once daily in the evening) over placebo with regard to the primary pulmonary function endpoint after 12 weeks of treatment.
Secondary objectives are to evaluate efficacy of tiotropium with regard to other endpoints, and to evaluate the safety of tiotropium, compared to placebo, as add-on controller therapy on top of usual care in this patient population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 392
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B tiotropium high dose - C placebo - A tiotropium low dose -
- Primary Outcome Measures
Name Time Method FEV1 peak0-3 Change From Baseline Baseline and 12 weeks Change from baseline in peak forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak0-3) measured at week 12.
Measured values presented are actually adjusted means.
- Secondary Outcome Measures
Name Time Method Trough FEV1 Change From Baseline Baseline and 12 weeks Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 12.
Measured values presented are actually adjusted means.FVC peak0-3 Change From Baseline Baseline and 12 weeks Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak0-3h) after 12 weeks of treatment.
The measured values presented are actually adjusted means.FEV1 AUC (0-3h) Change From Baseline Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks Change from baseline of area under the curve (AUC) from 0 to 3 hours for FEV1 (FEV1 AUC 0-3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
Measured values presented are actually adjusted means.FVC AUC (0-3h) Change From Baseline Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks Change from baseline of area under the curve (AUC) from 0 to 3 hours for FVC (Forced vital capacity) (FVC AUC0-3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
Measured values presented are actually adjusted means.Control of Asthma as Assessed by ACQ6 Score. Baseline and 12 weeks Change from baseline in Asthma Control Questionnaire (ACQ) 6 score measured at week 12
The ACQ is a scale containing 7 questions, each question has a 7 point scale which ranges from 0 to 6. A score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ6.
The measured values presented are actually adjusted means.ACQ6 Score Responders 12 weeks Responder rates based on the ACQ6 score after 12 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline \<= -0.5), no change (-0.5 \< change from trial baseline \<0.5) and worsening (change from trial baseline \>= 0.5).
The ACQ is a scale containing 7 questions, each question has a 7- point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ6 is calculated as the mean of the responses to the first 6 questions of the ACQ6.
No statistical testing was performed on ACQ6 responders.Control of Asthma as Assessed by ACQ Total Score Baseline and 12 weeks Change from baseline in Asthma Control Questionnaire (ACQ) total score measured at week 12.
The ACQ is a scale containing 7 questions. Each question has a 7 point scale which ranges from 0 to 6. A score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ total score is calculated as the mean of the responses to all 7 questions.
The measured values presented are actually adjusted means.ACQ Total Score Responders 12 weeks Responder rates based on the ACQ total score after 12 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 \<change from trial baseline \<0.5) and worsening (change from trial baseline ≥0.5) No statistical testing was performed for ACQ total score responders.
The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment.Use of PRN Rescue Medication During the Day Baseline and 12 weeks Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the day (24 hour period) based on the weekly mean at week 12.
The measured values presented are actually adjusted means.Use of PRN Rescue Medication During the Daytime Baseline and 12 weeks Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the daytime based on the weekly mean at week 12.
Measured values presented are actually adjusted means.Use of PRN Rescue Medication During the Night-time Baseline and 12 weeks Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the night-time based on the weekly mean at week 12.
Measured values presented are actually adjusted meansTime to First Severe Asthma Exacerbation During the 12-week Treatment Period. 12 weeks Time in days to first severe asthma exacerbation during the 12 week treatment period. The median time to first severe asthma exacerbation was not calculable, so the number of patients who experienced a severe asthma exacerbation are presented for the measured values.
A severe asthma exacerbation was defined as a subgroup of all asthma exacerbations that required an initiation of treatment with systemic corticosteroids for at least 3 days or, in case of ongoing and pre-existing systemic corticosteroid therapy, requiring at least doubling of previous daily doses of systemic corticosteroids for at least 3 days.Analysis of Time to First Asthma Exacerbation During the 12 Week Treatment Period. 12 weeks Time in days to first asthma exacerbation during the 12 week treatment period. The median time to first asthma exacerbation was not calculable, so the number of patients who experienced an asthma exacerbation are presented for the measured values.
Clinically Relevant Abnormalities for Physical Examination, ECG, Vital Signs and Laboratory Tests From first drug administration until 30 days after last drug intake, up to 142 days Clinically relevant abnormalities for physical examination, ECG, vital signs and laboratory tests. New abnormal findings or worsening of baseline conditions were reported as adverse events.
Trial Locations
- Locations (69)
205.456.01003 Boehringer Ingelheim Investigational Site
🇺🇸Baltimore, Maryland, United States
205.456.35101 Boehringer Ingelheim Investigational Site
🇵🇹Lisboa, Portugal
205.456.35103 Boehringer Ingelheim Investigational Site
🇵🇹Porto, Portugal
205.456.50201 Boehringer Ingelheim Investigational Site
🇬🇹Guatemala City, Guatemala
205.456.36004 Boehringer Ingelheim Investigational Site
🇭🇺Gyula, Hungary
205.456.52001 Boehringer Ingelheim Investigational Site
🇲🇽Hermosillo Sonora, Mexico
205.456.37104 Boehringer Ingelheim Investigational Site
🇱🇻Balvi, Latvia
205.456.35105 Boehringer Ingelheim Investigational Site
🇵🇹Coimbra, Portugal
205.456.38001 Boehringer Ingelheim Investigational Site
🇺🇦Lviv, Ukraine
205.456.09001 Boehringer Ingelheim Investigational Site
🇵🇭Quezon City, Philippines
205.456.38004 Boehringer Ingelheim Investigational Site
🇺🇦Kharkiv, Ukraine
205.456.35902 Boehringer Ingelheim Investigational Site
🇧🇬Plovdiv, Bulgaria
205.456.35903 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
205.456.61002 Boehringer Ingelheim Investigational Site
🇦🇺Parkville, Victoria, Australia
205.456.49001 Boehringer Ingelheim Investigational Site
🇩🇪Bochum, Germany
205.456.61001 Boehringer Ingelheim Investigational Site
🇦🇺Perth, Western Australia, Australia
205.456.36005 Boehringer Ingelheim Investigational Site
🇭🇺Budapest, Hungary
205.456.97205 Boehringer Ingelheim Investigational Site
🇮🇱Holon, Israel
205.456.50203 Boehringer Ingelheim Investigational Site
🇬🇹Guatemala City, Guatemala
205.456.36006 Boehringer Ingelheim Investigational Site
🇭🇺Nagyatad, Hungary
205.456.49008 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
205.456.49007 Boehringer Ingelheim Investigational Site
🇩🇪Neu-Isenburg, Germany
205.456.49010 Boehringer Ingelheim Investigational Site
🇩🇪Mainz, Germany
205.456.97201 Boehringer Ingelheim Investigational Site
🇮🇱Safed, Israel
205.456.50205 Boehringer Ingelheim Investigational Site
🇬🇹Guatemala City, Guatemala
205.456.36001 Boehringer Ingelheim Investigational Site
🇭🇺Miskolc, Hungary
205.456.37101 Boehringer Ingelheim Investigational Site
🇱🇻Baldone, Latvia
205.456.37103 Boehringer Ingelheim Investigational Site
🇱🇻Rezekne, Latvia
205.456.38007 Boehringer Ingelheim Investigational Site
🇺🇦Lviv, Ukraine
205.456.38006 Boehringer Ingelheim Investigational Site
🇺🇦Dnipropetrovsk, Ukraine
205.456.38005 Boehringer Ingelheim Investigational Site
🇺🇦Uzhgorod, Ukraine
205.456.38008 Boehringer Ingelheim Investigational Site
🇺🇦Vinnytsya, Ukraine
205.456.38002 Boehringer Ingelheim Investigational Site
🇺🇦Zaporizhzhya, Ukraine
205.456.01004 Boehringer Ingelheim Investigational Site
🇺🇸Stockton, California, United States
205.456.01002 Boehringer Ingelheim Investigational Site
🇺🇸Bellevue, Nebraska, United States
205.456.01001 Boehringer Ingelheim Investigational Site
🇺🇸Rockville Centre, New York, United States
205.456.01006 Boehringer Ingelheim Investigational Site
🇺🇸Summerville, South Carolina, United States
205.456.01005 Boehringer Ingelheim Investigational Site
🇺🇸Cincinnati, Ohio, United States
205.456.54002 Boehringer Ingelheim Investigational Site
🇦🇷Capital Federal, Argentina
205.456.54006 Boehringer Ingelheim Investigational Site
🇦🇷Capital Federal, Argentina
205.456.54008 Boehringer Ingelheim Investigational Site
🇦🇷Capital Federal, Argentina
205.456.54003 Boehringer Ingelheim Investigational Site
🇦🇷Florencio Varela, Argentina
205.456.54009 Boehringer Ingelheim Investigational Site
🇦🇷San Miguel de Tucuman, Argentina
205.456.54005 Boehringer Ingelheim Investigational Site
🇦🇷Mendoza, Argentina
205.456.54004 Boehringer Ingelheim Investigational Site
🇦🇷San Miguel de Tucumán, Argentina
205.456.35901 Boehringer Ingelheim Investigational Site
🇧🇬Ruse, Bulgaria
205.456.49004 Boehringer Ingelheim Investigational Site
🇩🇪Frankfurt, Germany
205.456.49005 Boehringer Ingelheim Investigational Site
🇩🇪Kehl, Germany
205.456.49003 Boehringer Ingelheim Investigational Site
🇩🇪Koblenz, Germany
205.456.49002 Boehringer Ingelheim Investigational Site
🇩🇪Wesel, Germany
205.456.50204 Boehringer Ingelheim Investigational Site
🇬🇹Guatemala City, Guatemala
205.456.36002 Boehringer Ingelheim Investigational Site
🇭🇺Debrecen, Hungary
205.456.36007 Boehringer Ingelheim Investigational Site
🇭🇺Mosdos, Hungary
205.456.97203 Boehringer Ingelheim Investigational Site
🇮🇱Petach Tikva, Israel
205.456.37102 Boehringer Ingelheim Investigational Site
🇱🇻Riga, Latvia
205.456.37105 Boehringer Ingelheim Investigational Site
🇱🇻Talsi, Latvia
205.456.52002 Boehringer Ingelheim Investigational Site
🇲🇽Monterrey, Mexico
205.456.52003 Boehringer Ingelheim Investigational Site
🇲🇽Monterrey, Mexico
205.456.52004 Boehringer Ingelheim Investigational Site
🇲🇽Nuevo León, Mexico
205.456.09002 Boehringer Ingelheim Investigational Site
🇵🇭Quezon City, Philippines
205.456.35102 Boehringer Ingelheim Investigational Site
🇵🇹Lisboa, Portugal
205.456.27001 Boehringer Ingelheim Investigational Site
🇿🇦Cape Town, South Africa
205.456.35104 Boehringer Ingelheim Investigational Site
🇵🇹Lisboa, Portugal
205.456.27002 Boehringer Ingelheim Investigational Site
🇿🇦Durban, South Africa
205.456.38003 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
205.456.38010 Boehringer Ingelheim Investigational Site
🇺🇦Kriviy Rig, Ukraine
205.456.38009 Boehringer Ingelheim Investigational Site
🇺🇦Kyiv, Ukraine
205.456.01007 Boehringer Ingelheim Investigational Site
🇺🇸Columbia, Missouri, United States
205.456.01008 Boehringer Ingelheim Investigational Site
🇺🇸Normal, Illinois, United States