Adults With Moderate to Severe Asthma - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00642122

Purpose

A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when given to asthma patients aged 12 years and above.

Condition	Intervention	Phase
Asthma	Drug: Budesonide	Phase III

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Blinded, Multicenter, Parallel Study Comparing the Efficacy and Safety of Pulmicort Respules at 0.5mg QD, 1.0mg QD, 1.0mg Bid, 2.0mg Bid and Pulmicort Turbuhaler at 4.00mcg Bid on Adolescents (12 Yrs of Age and Older) With Adults With Moderate to Severe Asthma.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Forced Expiratory Volume in 1 second in patients allocated treatment with Pulmicort REPSULES at 0.5mg and 2.0mg. [ Time Frame: Day -14, 1, and every 28 days thereafter ]

Secondary Outcome Measures:

Percentage of symptom free days [ Time Frame: Day -14, 1, and every 28 days thereafter ]
Percentage of symptom free nights [ Time Frame: Day -14, 1, and every 28 days thereafter ]
Percentage of symptom free 24-hours [ Time Frame: Day -14, 1, and every 28 days thereafter ]

Estimated Enrollment:	900
Study Start Date:	April 2003
Study Completion Date:	December 2004
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Pulmicort RESPULES	Drug: Budesonide 0.5mg once daily Drug: Budesonide 1mg once daily Drug: Budesonide 1mg twice daily Drug: Budesonide 2mg once daily
2: Experimental Pulmicort TURBUHALER	Drug: Budesonide 4.00mcg twice daily

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female aged 12 or over who have asthma
Ability to properly use an electronic diary
Able and willing to nebulize for up to 20 minutes every morning and evening

Exclusion Criteria:

Hospitalised at least one once or required emergency treatment due to asthma in the previous 6 months
Planned hospitalisation during the study
pregnant women or women planning to become pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642122

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Bertil Andersson

AstraZeneca

More Information

No publications provided

Responsible Party:	( Lars-Göran Carlsson )
Study ID Numbers:	SD-004-0764, D5257L00012
Study First Received:	March 18, 2008
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00642122 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Asthma
Pulmicort
budesonide
respules
turbuhaler

Study placed in the following topic categories:

Anti-Inflammatory Agents
Bronchial Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Asthma
Anti-Asthmatic Agents
Hormones
Glucocorticoids

Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

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 May 07, 2009