Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg
- Conditions
- Asthma
- Registration Number
- NCT00350207
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks.
The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 388
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial baseline and after 16 weeks of treatment Change from baseline in mean weekly morning peak expiratory flow at 16 weeks. Baseline is defined as the last week prior to the randomisation visit
- Secondary Outcome Measures
Name Time Method Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 16 After 16 weeks of treatment Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Mean Weekly Morning Peak Expiratory Flow at Week 8 After 8 weeks of treatment Mean weekly morning peak expiratory flow at week 8, pre-dose
Mean Weekly Morning Peak Expiratory Flow at Week 12 After 12 weeks of treatment Mean weekly morning peak expiratory flow at week 12, pre-dose
Mean Weekly Morning Peak Expiratory Flow at Week 16 After 16 weeks of treatment Mean weekly morning peak expiratory flow at week 16, pre-dose
Mean Weekly Evening Peak Expiratory Flow at Week 12 After 12 weeks of treatment Mean weekly evening peak expiratory flow at week 12, pre-dose
Mean Weekly Evening Peak Expiratory Flow at Week 16 After 16 weeks of treatment Mean weekly evening peak expiratory flow at week 16, pre-dose
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4 After 4 weeks of treatment Mean weekly morning forced expiratory volume in 1 second at week 4, pre-dose
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8 After 8 weeks of treatment Mean weekly morning forced expiratory volume in 1 second at week 8, pre-dose
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12 After 12 weeks of treatment Mean weekly morning forced expiratory volume in 1 second at week 12, pre-dose
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16 After 16 weeks of treatment Mean weekly morning forced expiratory volume in 1 second at week 16, pre-dose
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4 After 4 weeks of treatment Mean weekly evening forced expiratory volume in 1 second at week 4, pre-dose
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8 After 8 weeks of treatment Mean weekly evening forced expiratory volume in 1 second at week 8, pre-dose
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12 After 12 weeks of treatment Mean weekly evening forced expiratory volume in 1 second at week 12, pre-dose
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16 After 16 weeks of treatment Mean weekly evening forced expiratory volume in 1 second at week 16, pre-dose
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 4 After 4 weeks of treatment Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 8 After 8 weeks of treatment Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 12 After 12 weeks of treatment Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 16 After 16 weeks of treatment Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms in the Morning" at Week 4 After 4 weeks of treatment Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 8 After 8 weeks of treatment Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 12 After 12 weeks of treatment Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 16 After 16 weeks of treatment Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 4 After 4 weeks of treatment Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 8 After 8 weeks of treatment Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 12 After 12 weeks of treatment Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 4 After 4 weeks of treatment Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 8 After 8 weeks of treatment Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 12 After 12 weeks of treatment Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 16 After 16 weeks of treatment Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 4 After 4 weeks of treatment Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 8 After 8 weeks of treatment Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 12 After 12 weeks of treatment Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 16 After 16 weeks of treatment Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 4 After 4 weeks of treatment Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 8 After 8 weeks of treatment Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 12 After 12 weeks of treatment Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 16 After 16 weeks of treatment Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3 After 6 weeks of treatment Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 6 weeks of treatment
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4 After 12 weeks of treatment Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 12 weeks of treatment
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5 After 16 weeks of treatment Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 16 weeks od treatment
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5 After 16 weeks of treatment Morning pre-dose forced vital capacity as measured by spirometry after 16 weeks of treatment
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3 After 6 weeks of treatment Morning pre-dose forced vital capacity as measured by spirometry after 6 weeks of treatment
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4 After 12 weeks of treatment Morning pre-dose forced vital capacity as measured by spirometry after 12 weeks of treatment
Systolic Blood Pressure in Conjunction With Spirometry at Visit 5 After 16 weeks of treatment Systolic blood pressure collected in conjunction with spirometry at 16 weeks
Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3 After 6 weeks of treatment Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value
Mini-AQLQ Overall Score at Visit 4 After 12 weeks of treatment Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value
Systolic Blood Pressure in Conjunction With Spirometry at Visit 3 After 6 weeks of treatment Systolic blood pressure collected in conjunction with spirometry at 6 weeks
Systolic Blood Pressure in Conjunction With Spirometry at Visit 4 After 12 weeks of treatment Systolic blood pressure collected in conjunction with spirometry at 12 weeks
Pulse Rate in Conjunction With Spirometry at Visit 3 After 6 weeks of treatment Pulse rate collected in conjunction with spirometry at 6 weeks
Mean PEF Variability at Week 8 After 8 weeks of treatment PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%
Mean PEF Variability at Week 12 After 12 weeks of treatment PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%
Mini-AQLQ Overall Score at Visit 5 After 16 weeks of treatment Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5 After 16 weeks of treatment Diastolic blood pressure collected in conjunction with spirometry at 16 weeks
Pulse Rate in Conjunction With Spirometry at Visit 4 After 12 weeks of treatment Pulse rate collected in conjunction with spirometry at 12 weeks
Pulse Rate in Conjunction With Spirometry at Visit 5 After 16 weeks of treatment Pulse rate collected in conjunction with spirometry at 16 weeks
Mean PEF Variability at Week 4 After 4 weeks of treatment PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%
Mean PEF Variability at Week 16 After 16 weeks of treatment PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3 After 6 weeks of treatment Diastolic blood pressure collected in conjunction with spirometry at 6 weeks
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4 After 12 weeks of treatment Diastolic blood pressure collected in conjunction with spirometry at 12 weeks
Mean Weekly Morning Peak Expiratory Flow at Week 4 After 4 weeks of treatment Mean weekly morning peak expiratory flow at week 4, pre-dose
Mean Weekly Evening Peak Expiratory Flow at Week 4 After 4 weeks of treatment Mean weekly evening peak expiratory flow at week 4, pre-dose
Mean Weekly Evening Peak Expiratory Flow at Week 8 After 8 weeks of treatment Mean weekly evening peak expiratory flow at week 8, pre-dose
Trial Locations
- Locations (109)
205.342.43002 Boehringer Ingelheim Investigational Site
🇦🇹Graz, Austria
205.342.43004 Boehringer Ingelheim Investigational Site
🇦🇹Trofaiach, Austria
205.342.43003 Boehringer Ingelheim Investigational Site
🇦🇹Wels, Austria
205.342.43001 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
205.342.43005 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
205.342.43006 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
205.342.43007 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
205.342.32010 Boehringer Ingelheim Investigational Site
🇧🇪Anderlecht, Belgium
205.342.32005 Boehringer Ingelheim Investigational Site
🇧🇪Angleur, Belgium
205.342.32002 Boehringer Ingelheim Investigational Site
🇧🇪Brussel, Belgium
Scroll for more (99 remaining)205.342.43002 Boehringer Ingelheim Investigational Site🇦🇹Graz, Austria