Phase 3
Completed N=108
Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic Patients
Source: ClinicalTrials.gov NCT00855959 ↗Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcomePrimary: Morning Peak Expiratory Flow (mPEF) — 3.3 L/min
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Morning Peak Expiratory Flow (mPEF) |
3.3 | — |
| SECONDARY Evening Peak Expiratory Flow (ePEF) |
3.8 | — |
| SECONDARY Asthma Symptom Score (Daytime); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms) |
0.018 | — |
| SECONDARY Asthma Symptom Score (Night-time); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms) |
0.022 | — |
| SECONDARY Asthma Symptom Score (Total); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms) |
0.039 | — |
| SECONDARY Use of Rescue Medication (Daytime) |
0.017 | — |
| SECONDARY Use of Rescue Medication (Night-time) |
0.044 | — |
| SECONDARY Use of Rescue Medication (Total) |
0.061 | — |
| SECONDARY Night-time Awakenings Due to Asthma Symptoms |
-0.004 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV 1.0) |
0.079 | — |
| SECONDARY Forced Vital Capacity (FVC) |
0.105 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
50 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00855959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.