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Study Comparing Budesonide Hydrofluoroalkane (HFA) vs Chlorofluorocarbon (CFC) Pressurized Metered Dose Inhalers (pMDI) in Patients With Mild to Moderate Asthma

NCT ID: NCT00667992

Last Updated: 2012-11-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-05-31

Brief Summary

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This study is being carried out to see if budesonide with HFA is effective, safe and well tolerated compared with budesonide CFC. Budesonide HFA has been already given in other research studies, in both healthy volunteers and subjects with asthma.

Detailed Description

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Conditions

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Asthma

Keywords

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Asthma hyperreactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Budesonide Hydrofluoroalkane (HFA) 100

Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks

Group Type ACTIVE_COMPARATOR

Budesonide HFA

Intervention Type DRUG

standard daily inhaled dose

Budesonide HFA 400

Budesonide HFA 400 mcg twice daily for 2 weeks

Group Type ACTIVE_COMPARATOR

Budesonide HFA

Intervention Type DRUG

standard daily inhaled dose

Budesonide Chlorofluorocarbon (CFC) 100

Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks

Group Type ACTIVE_COMPARATOR

Budesonide CFC

Intervention Type DRUG

standard daily inhaled dose

Budesonide CFC 400

Budesonide CFC 400 mcg twice daily for 2 weeks

Group Type ACTIVE_COMPARATOR

Budesonide CFC

Intervention Type DRUG

standard daily inhaled dose

Interventions

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Budesonide HFA

standard daily inhaled dose

Intervention Type DRUG

Budesonide CFC

standard daily inhaled dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients suffering from stable, persistent, mild to moderate asthma as defined by Global Initiative for Asthma (GINA) Guidelines and for whom FEV1 \> 60 %
* ICS taking ≤ 1000 μg BDP per day, or equivalent
* Methacholine PC20 \< 4 mg/mL

Exclusion Criteria

* Known or suspected hypersensitivity to budesonide or any other constituents of the budesonide HFA pMDI or budesonide CFC pMDI.
* Currently a smoker or who has ceased smoking within 6 months of Visit 1.
* Exacerbations of asthma requiring oral steroids, hospitalisation or change in asthma therapy in the previous three months.
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or bronchiectasis
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian Lipworth, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Asthma and Allergy Research Group Division of Medicine and Therapeutics Ninewells Hospital and Medical School University of Dundee

Locations

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Research Site

King of Prussia, Pennsylvania, United States

Site Status

Research Site

Dundee, Scotland, United Kingdom

Site Status

Research Site

Perth, Scotland, United Kingdom

Site Status

Countries

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United States United Kingdom

References

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Anderson WJ, Short PM, Jabbal S, Lipworth BJ. Inhaled corticosteroid dose response in asthma: Should we measure inflammation? Ann Allergy Asthma Immunol. 2017 Feb;118(2):179-185. doi: 10.1016/j.anai.2016.11.018. Epub 2017 Jan 3.

Reference Type DERIVED
PMID: 28065396 (View on PubMed)

Other Identifiers

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D5252C00008

Identifier Type: -

Identifier Source: org_study_id