Asthma
Conditions
Keywords
Asthma, Pulmicort Respules
Brief summary
The primary objective of the study is to show similarity of efficacy on Pulmicort Respules 1.0 mg/day or 2.0 mg/day for 6 weeks in the treatment period and the corresponding doses of Pulmicort Turbuhaler 400 μg/day or 800 μg/day for 4 weeks in the observation period in Japanese adult asthmatic patients with age of 16 years or older.
Interventions
DRUGBudesonide
Inhalation powder, inhalation, twice daily, 4 weeks followed by Suspension for nebulisation, inhalation, once or twice daily, 6 weeks
Pulmicort Turbuhaler 200 µg, Dry powder inhaler, budesonide 200 µg/dose, 112 doses/Turbuhaler
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent prior to any study specific procedures. * A minimum of 6 months documented history of asthma according to the JGL 2006 definition * Asthma patients under prescribed treatment with ICS at least 3 months before Visit 2.
Exclusion criteria
* Current or previous tobacco smokers with a history of \>= 10 pack-years * Use of β-blockers including eye drops * Clinically significant respiratory infection affecting the asthma, as judged by the investigator(s) within 4 weeks prior to visit 2 * Intake of oral, rectal or parenteral GCS within 4 weeks prior to Visit 2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morning Peak Expiratory Flow (mPEF) | 6 weeks | Change in morning peak expiratory flow (mPEF) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Symptom Score (Daytime); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms) | 6 weeks | Change in Asthma symptom score (Daytime) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules) |
| Asthma Symptom Score (Night-time); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms) | 6 weeks | Change in Asthma symptom score (Night-time) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules) |
| Asthma Symptom Score (Total); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms) | 6 weeks | Change in Asthma symptom score (Total) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules) |
| Use of Rescue Medication (Daytime) | 6 weeks | Change in Use of rescue medication (Daytime) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules) |
| Use of Rescue Medication (Night-time) | 6 weeks | Change in Use of rescue medication (Night-time) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules) |
| Evening Peak Expiratory Flow (ePEF) | 6 weeks | Change in evening peak expiratory flow (ePEF) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules) |
| Night-time Awakenings Due to Asthma Symptoms | 6 weeks | Change in Night-time awakenings due to asthma symptoms from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules) |
| Forced Expiratory Volume in 1 Second (FEV 1.0) | 6 weeks | Change in Forced Expiratory Volume in 1 second (FEV 1.0) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules) |
| Forced Vital Capacity (FVC) | 6 weeks | Change in Forced Vital Capacity (FVC) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules) |
| Number of Participants With Adverse Events (AEs) | 6 weeks | Number of participants with AEs reported during the period on Pulmicort Respules |
| Use of Rescue Medication (Total) | 6 weeks | Change in Use of rescue medication (Total) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules) |
Countries
Japan
Participant flow
Recruitment details
Outpatients, male and female ≥ 16 years with stable asthma
Participants by arm
| Arm | Count |
|---|---|
| Pulmicort Turbuhaler and Pulmicort Respules 4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily | 106 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Incorrect enrolment | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Pulmicort Turbuhaler and Pulmicort Respules |
|---|---|
| Age Continuous | 43.9 Years STANDARD_DEVIATION 13.4 |
| Sex: Female, Male Female | 73 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 105 |
| serious Total, serious adverse events | 0 / 108 |
Outcome results
Primary
Morning Peak Expiratory Flow (mPEF)
Change in morning peak expiratory flow (mPEF) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmicort Turbuhaler and Pulmicort Respules | Morning Peak Expiratory Flow (mPEF) | 3.3 L/min | Standard Deviation 21.4 |
Secondary
Asthma Symptom Score (Daytime); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)
Change in Asthma symptom score (Daytime) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmicort Turbuhaler and Pulmicort Respules | Asthma Symptom Score (Daytime); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms) | 0.018 Scores on a scale | Standard Deviation 0.198 |
Secondary
Asthma Symptom Score (Night-time); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)
Change in Asthma symptom score (Night-time) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmicort Turbuhaler and Pulmicort Respules | Asthma Symptom Score (Night-time); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms) | 0.022 Scores on a scale | Standard Deviation 0.185 |
Secondary
Asthma Symptom Score (Total); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)
Change in Asthma symptom score (Total) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmicort Turbuhaler and Pulmicort Respules | Asthma Symptom Score (Total); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms) | 0.039 Scores on a scale | Standard Deviation 0.346 |
Secondary
Evening Peak Expiratory Flow (ePEF)
Change in evening peak expiratory flow (ePEF) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmicort Turbuhaler and Pulmicort Respules | Evening Peak Expiratory Flow (ePEF) | 3.8 L/min | Standard Deviation 18.1 |
Secondary
Forced Expiratory Volume in 1 Second (FEV 1.0)
Change in Forced Expiratory Volume in 1 second (FEV 1.0) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmicort Turbuhaler and Pulmicort Respules | Forced Expiratory Volume in 1 Second (FEV 1.0) | 0.079 L | Standard Deviation 0.244 |
Secondary
Forced Vital Capacity (FVC)
Change in Forced Vital Capacity (FVC) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmicort Turbuhaler and Pulmicort Respules | Forced Vital Capacity (FVC) | 0.105 L | Standard Deviation 0.283 |
Secondary
Night-time Awakenings Due to Asthma Symptoms
Change in Night-time awakenings due to asthma symptoms from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmicort Turbuhaler and Pulmicort Respules | Night-time Awakenings Due to Asthma Symptoms | -0.004 awakenings | Standard Deviation 0.165 |
Secondary
Number of Participants With Adverse Events (AEs)
Number of participants with AEs reported during the period on Pulmicort Respules
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulmicort Turbuhaler and Pulmicort Respules | Number of Participants With Adverse Events (AEs) | 50 Participants |
Secondary
Use of Rescue Medication (Daytime)
Change in Use of rescue medication (Daytime) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmicort Turbuhaler and Pulmicort Respules | Use of Rescue Medication (Daytime) | 0.017 puffs | Standard Deviation 0.16 |
Secondary
Use of Rescue Medication (Night-time)
Change in Use of rescue medication (Night-time) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmicort Turbuhaler and Pulmicort Respules | Use of Rescue Medication (Night-time) | 0.044 puffs | Standard Deviation 0.22 |
Secondary
Use of Rescue Medication (Total)
Change in Use of rescue medication (Total) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmicort Turbuhaler and Pulmicort Respules | Use of Rescue Medication (Total) | 0.061 puffs | Standard Deviation 0.317 |