Asthma
Conditions
Keywords
asthma, children, budesonide pMDI
Brief summary
This purpose of the study is to investigate if budesonide pMDI 160 �g twice a day during 6 weeks is effective and safe in treating asthmatic children aged 6 to \<12 years
Detailed description
Phase 2, double-blind, randomized, parallel-group, placebo-controlled, multicenter study, comparing budesonide pMDI 160 �g bid with placebo: a 6-week efficacy and safety study in children aged 6 to \<12 years with asthma
Interventions
DRUGbudesonide
pMDI, inhalation, bid, 6 weeks
DRUGplacebo
pMDI, inhalation, bid, 6 weeks
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Has a documented clinical diagnosis of asthma for at least 6 months prior to Visit 2 that has required daily inhaled corticosteroid in the low dose range OR LTRA as monotherapy for at least 30 days prior to Visit 2. * Has a morning clinic pre-bronchodilator FEV1 measured at least 6 hours after the last dose of inhaled short acting beta agonist of greater than or equal to 70% and less than or equal to 95% of predicted normal * Demonstrated reversibility of FEV1 of ≥12% from pre short acting beta agonist level within 15 to 30 minutes after administration of a standard dose of short acting beta agonist OR has a documented reversibility of ≥ 12 % within 12 months prior to Visit 2.
Exclusion criteria
* Has been hospitalized at least once or required emergency treatment (was seen in the emergency room or had an urgent care visit) more than once for an asthma-related condition during the 6 months prior to Visit 2 * Has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 12 weeks prior to Visit 2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average | Baseline to 6 weeks | The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Evening PEF From Baseline to the Treatment Period Average | Baseline to 6 weeks | The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period. |
| Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average | Baseline to 6 weeks | FVC is the total volume of air expired after a full inspiration. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period. |
| Change in Forced Mid-expiratory Flow Between 25% and 75% of the FVC (FEF25-75) From Baseline to Treatment Period Average | Baseline to 6 weeks | FEF25-75 is the average rate of airflow during the midportion of the forced vital capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period. |
| Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average | Baseline to 6 weeks | Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were used: 0 = None; no symptoms of asthma; 1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated; 2 = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep; 3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep. |
| Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average | Baseline to 6 weeks | FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period. |
| Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average | Baseline to 6 weeks | Patients, with the help of their caregiver, were asked to respond to a standard question each morning as they completed their eDiary. The question to be answered was, Did your asthma cause you to wake-up last night? If yes, patients were asked, Did you need to use your reliever medication (albuterol/salbutamol inhaler) before you went back to sleep? Baseline is defined as the percentage of days where patient experienced nighttime awakenings out of all available days where data was collected during the last 7 days of the run-in period. |
| Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average | Baseline to 6 weeks | The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, How many albuterol/salbutamol inhalations since last diary entry? |
| Change in Nighttime Reliever Medication Use From Baseline to Treatment Period Average | Baseline to 6 weeks | The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, How many albuterol/salbutamol inhalations since last diary entry? |
| Number of Withdrawals Due to Pre-defined Asthma Events | Baseline to 6 weeks | Patients were considered to have experienced a pre-defined asthma event if any of the following conditions were met during the study: 1. At each visit or follow-up visit, a decrease in morning pre-dose FEV1 \>=20% from the Visit 3 (randomization visit) morning pre-dose FEV1 or a decrease to \<65% of predicted normal value; 2. The use of \>=8 actuations of albuterol/salbutamol per day on 3 or more days within any period of 7 consecutive days following randomization; 3. A decrease in morning PEF \>=20% from baseline on 3 or more days within any period of 7 consecutive days after randomization; 4. Two or more nights with an awakening due to asthma, which required the use of reliever medication within any period of 7 consecutive days after randomization; 5. A clinical exacerbation requiring emergency treatment, hospitalization, or use of an asthma medication not allowed by the study protocol. |
| Change in Nighttime Asthma Symptom Score From Baseline to Treatment Period Average | Baseline to 6 weeks | Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were used: 0 = None; no symptoms of asthma; 1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated; 2 = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep; 3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep. |
Countries
Bulgaria, Hungary, Latvia, Poland, Slovakia, South Africa, United States
Participant flow
Recruitment details
This multicenter study was conducted in Bulgaria, Hungary, Latvia, Poland, Slovakia, South Africa, and the United States between 07 August 2011 and 05 April 2013.
Pre-assignment details
The study consisted of a screening visit (Visit 1), an enrollment visit (Visit 2), a 7- to 21-day run-in/qualification period, a randomization visit (Visit 3), and 6 further weekly visits during a treatment period of 6 weeks. A telephone follow-up was conducted approximately 2 weeks after the final study visit.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo pMDI bid | 152 |
| Budesonide Budesonide pMDI 160 mcg bid | 152 |
| Total | 304 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Other | 8 | 3 |
| Overall Study | Severe Non-Compliance to Protocol | 0 | 2 |
| Overall Study | Study-Specific Withdrawal Criteria | 48 | 25 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Placebo | Budesonide | Total |
|---|---|---|---|
| Age, Continuous | 9.0 years STANDARD_DEVIATION 1.62 | 9.0 years STANDARD_DEVIATION 1.63 | 9.0 years STANDARD_DEVIATION 1.62 |
| Age, Customized 6 to <8 years | 33 participants | 33 participants | 66 participants |
| Age, Customized 8 to- <12 years | 119 participants | 119 participants | 238 participants |
| Forced expiratory volume in 1 second (FEV1) | 1.70 liters STANDARD_DEVIATION 0.416 | 1.69 liters STANDARD_DEVIATION 0.388 | 1.70 liters STANDARD_DEVIATION 0.401 |
| Race/Ethnicity, Customized African American | 7 participants | 9 participants | 16 participants |
| Race/Ethnicity, Customized Asian (other than Chinese and Japanese) | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 10 participants | 11 participants | 21 participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Not Applicable | 128 participants | 126 participants | 254 participants |
| Race/Ethnicity, Customized Other | 6 participants | 4 participants | 10 participants |
| Sex: Female, Male Female | 58 Participants | 54 Participants | 112 Participants |
| Sex: Female, Male Male | 94 Participants | 98 Participants | 192 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 27 / 152 | 40 / 152 |
| serious Total, serious adverse events | 0 / 152 | 0 / 152 |
Outcome results
Primary
Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average
The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
Time frame: Baseline to 6 weeks
Population: The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average | 4.1 liters/minute | Standard Error 3.19 |
| Budesonide | Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average | 17.8 liters/minute | Standard Error 3.24 |
Comparison: Change from baseline to treatment period average was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.p-value: <0.000195% CI: [7.5, 19.7]ANCOVA
Secondary
Change in Evening PEF From Baseline to the Treatment Period Average
The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
Time frame: Baseline to 6 weeks
Population: The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Evening PEF From Baseline to the Treatment Period Average | 4.0 liters/minute | Standard Error 3.08 |
| Budesonide | Change in Evening PEF From Baseline to the Treatment Period Average | 14.7 liters/minute | Standard Error 3.13 |
Comparison: Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.p-value: 0.000495% CI: [4.9, 16.7]ANCOVA
Secondary
Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average
FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
Time frame: Baseline to 6 weeks
Population: The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average | 0.00 liters | Standard Error 0.023 |
| Budesonide | Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average | 0.06 liters | Standard Error 0.023 |
Comparison: Change from baseline to treatment period average was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.p-value: 0.004795% CI: [0.02, 0.11]ANCOVA
Secondary
Change in Forced Mid-expiratory Flow Between 25% and 75% of the FVC (FEF25-75) From Baseline to Treatment Period Average
FEF25-75 is the average rate of airflow during the midportion of the forced vital capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
Time frame: Baseline to 6 weeks
Population: The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Forced Mid-expiratory Flow Between 25% and 75% of the FVC (FEF25-75) From Baseline to Treatment Period Average | 0.01 liters/second | Standard Error 0.045 |
| Budesonide | Change in Forced Mid-expiratory Flow Between 25% and 75% of the FVC (FEF25-75) From Baseline to Treatment Period Average | 0.11 liters/second | Standard Error 0.045 |
Comparison: Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.p-value: 0.021695% CI: [0.01, 0.19]ANCOVA
Secondary
Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average
FVC is the total volume of air expired after a full inspiration. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
Time frame: Baseline to 6 weeks
Population: The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average | 0.00 liters | Standard Error 0.021 |
| Budesonide | Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average | 0.04 liters | Standard Error 0.021 |
Comparison: Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.p-value: 0.067395% CI: [0, 0.08]ANCOVA
Secondary
Change in Nighttime Asthma Symptom Score From Baseline to Treatment Period Average
Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were used: 0 = None; no symptoms of asthma; 1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated; 2 = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep; 3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep.
Time frame: Baseline to 6 weeks
Population: The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Nighttime Asthma Symptom Score From Baseline to Treatment Period Average | -0.3 units on a scale | Standard Error 0.06 |
| Budesonide | Change in Nighttime Asthma Symptom Score From Baseline to Treatment Period Average | -0.4 units on a scale | Standard Error 0.06 |
Comparison: Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.p-value: 0.007995% CI: [-0.26, -0.04]ANCOVA
Secondary
Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average
Patients, with the help of their caregiver, were asked to respond to a standard question each morning as they completed their eDiary. The question to be answered was, Did your asthma cause you to wake-up last night? If yes, patients were asked, Did you need to use your reliever medication (albuterol/salbutamol inhaler) before you went back to sleep? Baseline is defined as the percentage of days where patient experienced nighttime awakenings out of all available days where data was collected during the last 7 days of the run-in period.
Time frame: Baseline to 6 weeks
Population: The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average | Nighttime awakenings | -9.8 percentage of days with awakenings | Standard Error 1.81 |
| Placebo | Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average | Nighttime awakenings with reliever use | -6.1 percentage of days with awakenings | Standard Error 1.17 |
| Budesonide | Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average | Nighttime awakenings | -14.5 percentage of days with awakenings | Standard Error 1.84 |
| Budesonide | Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average | Nighttime awakenings with reliever use | -10.0 percentage of days with awakenings | Standard Error 1.18 |
Comparison: Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.p-value: 0.009595% CI: [-8.2, -1.1]ANCOVA
Comparison: Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.p-value: 0.000795% CI: [-6.2, -1.7]ANCOVA
Secondary
Change in Nighttime Reliever Medication Use From Baseline to Treatment Period Average
The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, How many albuterol/salbutamol inhalations since last diary entry?
Time frame: Baseline to 6 weeks
Population: The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Nighttime Reliever Medication Use From Baseline to Treatment Period Average | -0.1 inhalations per day | Standard Error 0.06 |
| Budesonide | Change in Nighttime Reliever Medication Use From Baseline to Treatment Period Average | -0.4 inhalations per day | Standard Error 0.06 |
Comparison: Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.p-value: <0.000195% CI: [-0.3, -0.1]ANCOVA
Secondary
Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average
Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were used: 0 = None; no symptoms of asthma; 1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated; 2 = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep; 3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep.
Time frame: Baseline to 6 weeks
Population: The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average | Total asthma symptom score | -0.5 units on a scale | Standard Error 0.11 |
| Placebo | Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average | Daytime asthma symptom score | -0.2 units on a scale | Standard Error 0.06 |
| Budesonide | Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average | Daytime asthma symptom score | -0.4 units on a scale | Standard Error 0.06 |
| Budesonide | Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average | Total asthma symptom score | -0.8 units on a scale | Standard Error 0.11 |
Comparison: Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.p-value: 0.000495% CI: [-0.31, -0.09]ANCOVA
Comparison: Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.p-value: 0.001595% CI: [-0.55, -0.13]ANCOVA
Secondary
Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average
The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, How many albuterol/salbutamol inhalations since last diary entry?
Time frame: Baseline to 6 weeks
Population: The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average | Daytime reliever medication use | -0.1 inhalations per day | Standard Error 0.07 |
| Placebo | Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average | Total reliever medication use | -0.3 inhalations per day | Standard Error 0.11 |
| Budesonide | Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average | Total reliever medication use | -0.7 inhalations per day | Standard Error 0.11 |
| Budesonide | Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average | Daytime reliever medication use | -0.4 inhalations per day | Standard Error 0.07 |
Comparison: Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.p-value: 0.000195% CI: [-0.4, -0.1]ANCOVA
Comparison: Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.p-value: <0.000195% CI: [-0.7, -0.2]ANCOVA
Secondary
Number of Withdrawals Due to Pre-defined Asthma Events
Patients were considered to have experienced a pre-defined asthma event if any of the following conditions were met during the study: 1. At each visit or follow-up visit, a decrease in morning pre-dose FEV1 \>=20% from the Visit 3 (randomization visit) morning pre-dose FEV1 or a decrease to \<65% of predicted normal value; 2. The use of \>=8 actuations of albuterol/salbutamol per day on 3 or more days within any period of 7 consecutive days following randomization; 3. A decrease in morning PEF \>=20% from baseline on 3 or more days within any period of 7 consecutive days after randomization; 4. Two or more nights with an awakening due to asthma, which required the use of reliever medication within any period of 7 consecutive days after randomization; 5. A clinical exacerbation requiring emergency treatment, hospitalization, or use of an asthma medication not allowed by the study protocol.
Time frame: Baseline to 6 weeks
Population: The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Withdrawals Due to Pre-defined Asthma Events | 50 participants |
| Budesonide | Number of Withdrawals Due to Pre-defined Asthma Events | 25 participants |
p-value: 0.0004Log Rank