Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort Pressurized Metered-dose Inhaler (pMDI) or Oxis Turbuhaler

NCT ID: NCT00658255

Last Updated: 2011-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2003-05-31

Brief Summary

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The purpose of this study is to compare the therapeutic effects of formoterol in Symbicort with formoterol in Oxis Turbuhaler for the treatment of adults with stable asthma.

Detailed Description

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Conditions

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Stable Asthma

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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1

Group Type EXPERIMENTAL

budesonide/formoterol

Intervention Type DRUG

2

Group Type ACTIVE_COMPARATOR

formoterol

Intervention Type DRUG

Interventions

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budesonide/formoterol

Intervention Type DRUG

formoterol

Intervention Type DRUG

Other Intervention Names

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Symbicort Oxis Turbuhaler

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age
* Diagnosis of asthma and baseline lung function tests as determined by the protocol
* Required and received treatment with inhaled corticosteroids within timeframe and doses specified in the protocol

Exclusion Criteria

* Severe asthma
* Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Michael E Ruff, MD

Role: STUDY_DIRECTOR

Pharmaceutical Research & Consulting Inc

Catherine Bonuccelli

Role: STUDY_CHAIR

AstraZeneca

Other Identifiers

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D5896C00729

Identifier Type: -

Identifier Source: secondary_id

SD-039-0729

Identifier Type: -

Identifier Source: org_study_id

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