New Version Pulmicort Turbuhaler USA Adults - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00642187

Purpose

A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in adult patients who have asthma and are currently being treated with inhaled steroids. In addition the study evaluated the functionality of the new inhaler at the end of its intended life.

Condition	Intervention	Phase
Asthma	Drug: budesonide Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	A Placebo-controlled Comparison of the Efficacy and Safety of the Current US Version of Pulmicort (Budesonide) Turbuhaler and the New Version of Pulmicort Turbuhaler in Asthmatic Adults Currently Treated With Inhaled Steroids.

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:

Change from Baseline in Forced Expiratory Volume in 1 second [ Time Frame: Week 2, 4 and 8, then at week 12 ]

Secondary Outcome Measures:

Change from baseline in Forced Vital Capacity, Morning Peak Expiratory Flow, Daytime and nighttime asthma symptom scores, beta-agonist use and discontinuation rate. [ Time Frame: Week 2, 4 and 8, then at week 12 ]
Incidence of Adverse Events [ Time Frame: Week 2,4 and 8, then at week 12 ]
Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration) [ Time Frame: 6 or 12 hours post dose ]

Estimated Enrollment:	525
Study Start Date:	July 2002
Study Completion Date:	October 2004
Primary Completion Date:	October 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Pulmicort	Drug: budesonide Other Name: Pulmicort
Placebo Comparator: 2 Placebo	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females at least 18 years old with a diagnosis of asthma (as defined by the ATS) for at least 6 months.
To enter the run in period, subjects were also required to have the following:
A forced expiratory volume (FEV1) in 1 second of 60% to 90% of predicted normal, airway reversibility of at least 12% and 0.20 L, use of orally inhaled corticosteroids for at least 3 months prior to the study.
At Visit 2, subjects who met additional entry criteria related to rescue medication use and asthma symptom scores during the run in period plus visit specific FEV1 requirements were assigned to randomized treatments

Exclusion Criteria:

Life threatening asthma, Two or more overnight hospitalisations for asthma within 1 year or any emergency room visit for asthma within 6 months of starting study.
Use of steroid tablets or injections during the month (28 days) prior to Visit 1 and use of other asthma medicines (except rescue medication) within 2 weeks prior to the study.
Any acute exacerbation of asthma or a respiratory tract infection within 30 days prior to the study. Subject must not smoke or have smoked within 6 months of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642187

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Bertil Andersson	AZ employee
Study Director:	Lars-Göran Carlsson	AZ employee

More Information

No publications provided

Responsible Party:	Lars-Göran Carlsson
ClinicalTrials.gov Identifier:	NCT00642187 History of Changes
Other Study ID Numbers:	SD-004-0620, D5254C00620
Study First Received:	March 18, 2008
Last Updated:	January 21, 2011
Health Authority:	United States: Food and Drug Administration; Indonesia: National Food and Drug Agency; Philippines: Bureau of Food and Drugs

Keywords provided by AstraZeneca:

Asthma
Pulmicort
Turbuhaler
Budesonide
Flexhaler

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Bronchodilator Agents

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012