Clinical trial NCT00855959: Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic Patients
Official title: An Evaluation of Efficacy and Safety of Corresponding Doses of Pulmicort Turbuhaler® and Pulmicort Respules® in Japanese Asthmatic Adult Patients (Open, Multicenter, Phase III Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Pulmicort Respules
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-03-05
Enrollment: 108
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Morning Peak Expiratory Flow (mPEF)
timeFrame: 6 weeks
Secondary outcomes:
measure: Evening Peak Expiratory Flow (ePEF)
timeFrame: 6 weeks
measure: Asthma Symptom Score (Daytime); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)
timeFrame: 6 weeks
measure: Asthma Symptom Score (Night-time); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)
timeFrame: 6 weeks
measure: Asthma Symptom Score (Total); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)
timeFrame: 6 weeks
measure: Use of Rescue Medication (Daytime)
timeFrame: 6 weeks
measure: Use of Rescue Medication (Night-time)
timeFrame: 6 weeks
measure: Use of Rescue Medication (Total)
timeFrame: 6 weeks
measure: Night-time Awakenings Due to Asthma Symptoms
timeFrame: 6 weeks
measure: Forced Expiratory Volume in 1 Second (FEV 1.0)
timeFrame: 6 weeks
measure: Forced Vital Capacity (FVC)
timeFrame: 6 weeks
measure: Number of Participants With Adverse Events (AEs)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Ichikawa
country: Japan
facility: Research Site
state: Chiba
city: Yokosuka
country: Japan
facility: Research Site
state: Kanagawa
city: Chiyoda
country: Japan
facility: Research Site
state: Tokyo
city: Hino
country: Japan
facility: Research City
state: Tokyo
city: Setagaya
country: Japan
facility: Research Site
state: Tokyo
city: Tachikawa
country: Japan
facility: Research Site
state: Tokyo
Study officials:
affiliation: AstraZeneca R&D Lund
name: Lars-Göran Carlsson, MD
role: STUDY_DIRECTOR
References: