Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic Patients - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00855959

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Pulmicort Respules Drug: Pulmicort Turbuhaler	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study
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)

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

PEF (mPEF) [ Time Frame: Daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PEF (ePEF), Asthma symptom score - day, night and total, Use of rescue medication - day, night and total, Nighttime awakenings due to asthma symptoms [ Time Frame: daily ] [ Designated as safety issue: No ]
Forced expiratory volume in one second (FEV1.0), Forced vital capacity (FVC) [ Time Frame: Visit 2 and 5 ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	February 2009
Estimated Study Completion Date:	August 2009

Arms	Assigned Interventions
1: Experimental Pulmicort Turbuhaler at a dose of 400 μg twice daily and Pulmicort Respules at a dose of 1.0 mg twice daily (High Dose)	Drug: Pulmicort Respules Pulmicort Respules 0.5 mg, Inhalation suspension, budesonide 0.5 mg/ampoule (2 mL)
2: Experimental Pulmicort Turbuhaler at a dose of 200 μg twice daily and Pulmicort Respules at a dose of 0.5 mg twice daily or 1.0 mg once daily (low dose)	Drug: Pulmicort Turbuhaler Pulmicort Turbuhaler 200 µg, Dry powder inhaler, budesonide 200 µg/dose, 112 doses/Turbuhaler

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855959

Contacts

Contact: AstraZeneca Clinical Study Information

1-800-236-9933

information.center@astrazeneca.com

Locations

Japan, Chiba
Research Site	Recruiting
Ichikawa, Chiba, Japan
Japan, Kanagawa
Research Site	Recruiting
Yokosuka, Kanagawa, Japan
Japan, Tokyo
Research Site	Not yet recruiting
Tachikawa, Tokyo, Japan
Research Site	Not yet recruiting
Setagaya, Tokyo, Japan
Research Site	Active, not recruiting
Chiyoda, Tokyo, Japan
Research City	Recruiting
Hino, Tokyo, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Lars-Göran Carlsson, MD

AstraZeneca R&D Lund

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Carlsson, Lars-Goran, MD, Medical Science Director, Est.Respiratory Brands )
Study ID Numbers:	D5259C00001
Study First Received:	March 4, 2009
Last Updated:	March 4, 2009
ClinicalTrials.gov Identifier:	NCT00855959 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:

Asthma
Pulmicort Respules

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Asthma
Hormones
Glucocorticoids

Pharmacologic Actions
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010