Trial Outcomes & Findings for Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic Patients (NCT NCT00855959)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

108 participants

Primary outcome timeframe

6 weeks

Results posted on

2011-03-11

Participant Flow

Outpatients, male and female ≥ 16 years with stable asthma

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	108
Overall Study Patients Who Received Pulmicort Respules	105
Overall Study COMPLETED	99
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Adverse Event	2
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	3
Overall Study Pregnancy	1
Overall Study Incorrect enrolment	1

Baseline Characteristics

Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pulmicort Turbuhaler and Pulmicort Respules n=106 Participants 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
Age Continuous	43.9 Years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	73 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Pulmicort Turbuhaler and Pulmicort Respules n=105 Participants 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
Morning Peak Expiratory Flow (mPEF)	3.3 L/min Standard Deviation 21.4

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Pulmicort Turbuhaler and Pulmicort Respules n=105 Participants 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
Evening Peak Expiratory Flow (ePEF)	3.8 L/min Standard Deviation 18.1

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Pulmicort Turbuhaler and Pulmicort Respules n=105 Participants 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
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 outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Pulmicort Turbuhaler and Pulmicort Respules n=105 Participants 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
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 outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Pulmicort Turbuhaler and Pulmicort Respules n=105 Participants 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
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 outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Pulmicort Turbuhaler and Pulmicort Respules n=105 Participants 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
Use of Rescue Medication (Daytime)	0.017 puffs Standard Deviation 0.160

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Pulmicort Turbuhaler and Pulmicort Respules n=105 Participants 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
Use of Rescue Medication (Night-time)	0.044 puffs Standard Deviation 0.220

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Pulmicort Turbuhaler and Pulmicort Respules n=105 Participants 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
Use of Rescue Medication (Total)	0.061 puffs Standard Deviation 0.317

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Pulmicort Turbuhaler and Pulmicort Respules n=105 Participants 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
Night-time Awakenings Due to Asthma Symptoms	-0.004 awakenings Standard Deviation 0.165

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Pulmicort Turbuhaler and Pulmicort Respules n=102 Participants 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
Forced Expiratory Volume in 1 Second (FEV 1.0)	0.079 L Standard Deviation 0.244

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Pulmicort Turbuhaler and Pulmicort Respules n=102 Participants 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
Forced Vital Capacity (FVC)	0.105 L Standard Deviation 0.283

SECONDARY outcome

Timeframe: 6 weeks

Number of participants with AEs reported during the period on Pulmicort Respules

Outcome measures

Outcome measures
Measure	Pulmicort Turbuhaler and Pulmicort Respules n=105 Participants 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
Number of Participants With Adverse Events (AEs)	50 Participants

Adverse Events

Pulmicort Turbuhaler and Pulmicort Respules

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pulmicort Turbuhaler and Pulmicort Respules n=105 participants at risk；n=108 participants at risk 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
Renal and urinary disorders Nasopharyngitis	6.7% 7/105

Additional Information

Gerard Lynch

AstraZeneca

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60