Efficacy And Safety Of GW642444M Comparing Placebo In Adolescent And Adult Subjects With Persistent Asthma.
- Conditions
- Asthma
- Interventions
- Drug: GW642444MDrug: Placebo
- Registration Number
- NCT00600171
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study is designed to determine if the investigational drug is effective and safe in individuals with asthma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 614
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GW642444M GW642444M GW642444M Placebo Placebo Placebo Multi dose dry powder inhlaer
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in Clinic Visit Trough FEV1 at Day 28 (Last Observation Carried Forward [LOCF]) Baseline and Day 28 Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 at the end of the 28-day treatment period, with the trough FEV1 defined as the mean of the 23 hour and 24 hour post-dose assessments on Day 28. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) using LOCF with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, and treatment.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in Clinic Visit Trough FEV1 at Day 28 Per Stratum (LOCF) Baseline and Day 28 Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 at the end of the 28-day treatment period, with the trough FEV1 defined as the mean of the 23 hour and 24 hour post-dose assessments on Day 28. Change from Baseline in trough FEV1 at the end of the treatment period (23 hours and 24 hours after dosing on Day 28) was analyzed for each stratum (Lower stratum: FEV1 percent predicted, \>=40% to \<=65%; Upper stratum: FEV1 percent predicted, \>=65% to \<=90%). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA using LOCF with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, treatment, and treatment by stratum interaction.
Change From Baseline in Weighted Mean 24-hour Serial FEV1 at Day 1 and Day 28 Baseline; Day 1 and Day 28 (mean post-dose FEV1 after 15, 30, and 60 minutes and 2, 3, 4, 6, 12, 16, 20, 22, 23, and 24 hours) Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Change from Baseline in weighted mean for 24-hour serial FEV1 on Days 1 and Day 28 was assessed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, and treatment.
Mean Change From Baseline in Trough (Pre-dose and Pre-bronchodilator) Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 28-day Treatment Period Baseline and Days 1-28 Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily PM over the 28-day treatment period (at Day 28) minus the Baseline value (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.
Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 28-day Treatment Period Baseline and Days 1-28 Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily AM over the 28-day treatment period (at Day 28) minus the Baseline value (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.
Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Averaged Over the 28-day Treatment Period Baseline and Days 1-28 Participants who were symptom free for 24 hours were assessed. Change from Baseline was calculated as the value at Day 28 minus the value at Baseline (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.
Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Averaged Over the 28-day Treatment Period Baseline and Days 1-28 The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. Change from Baseline is calculated as the value at Day 28 minus the value at Baseline (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.
Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30 Minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: 24 Hours After Dosing on Day 1 and Day 28 24 hours after dosing on Day 1 (Visit 2) and on Day 28 (Visit 5) Assessment at Visit 2/2a was made prior to the evening dose of study medication on Day 2. Participants were administered a single 400 µg dose of salbutamol/albuterol, and FEV1 was measured 30 minutes after this administration. The highest of three technically acceptable measurements was recorded. These assessments were performed as follows: between 5 PM and 10 PM, \>=6 hours after the last use of salbutamol/albuterol, \>=6 hours after the last caffeine consumption, \>=2 hours after exercise (or strenuous activity), \>=24 hours after the first dose (Visit 2) or last dose (Visit 5) of study medication. Analysis was performed using ANCOVA with covariates of Baseline (pre-salbutamol measurement at Screening), country, sex, age, stratum, and treatment. Analysis is of the differences in absolute FEV1 measurements taken post-salbutamol/albuterol.
Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: Screening and 24 Hours After Dosing on Day 1 Screening (Visit 1) and 24 hours after dosing on Day 1 (Visit 2) Assessment at Visit 2/2a was made prior to the evening dose of study medication on Day 2. Participants were administered a single 400 µg dose of salbutamol/albuterol, and FEV1 was measured 30 minutes after this administration. The highest of three technically acceptable measurements was recorded. These assessments were performed as follows: between 5 PM and 10 PM, \>=6 hours after the last use of salbutamol/albuterol, \>=6 hours after the last caffeine consumption, \>=2 hours after exercise (or strenuous activity), Screening and \>=24 hours after the first dose (Visit 2) of study medication. Analysis was performed using ANCOVA with covariates of Baseline (pre-salbutamol measurement at Screening), country, sex, age, stratum, and treatment. Analysis is of the differences in absolute FEV1 measurements taken post-salbutamol/albuterol.
Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30 Minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: Screening and 24 Hours After Dosing on Day 28 Screening (Visit 1) and 24 hours after dosing on Day 28 (Visit 5) Assessment at Visit 2/2a was made prior to the evening dose of study medication on Day 2. Participants were administered a single 400 µg dose of salbutamol/albuterol, and FEV1 was measured 30 minutes after this administration. The highest of three technically acceptable measurements was recorded. These assessments were performed as follows: between 5 PM and 10 PM, \>=6 hours after the last use of salbutamol/albuterol, \>=6 hours after the last caffeine consumption, \>=2 hours after exercise (or strenuous activity), Screening and \>=24 hours after the first dose (Visit 2) of study medication. Analysis was performed using ANCOVA with covariates of Baseline (pre-salbutamol measurement at Screening), country, sex, age, stratum, and treatment. Analysis is of the differences in absolute FEV1 measurements taken post-salbutamol/albuterol.
Trial Locations
- Locations (1)
GSK Investigational Site
🇹🇭Khon Kaen, Thailand