Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics

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

PHASE1/PHASE2

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-02-28

Brief Summary

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The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbohaler in terms of the drug absorbed into the bloodstream.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Budesonide/formoterol Easyhaler

Group Type EXPERIMENTAL

budesonide and formoterol 200/6 microg

Intervention Type DRUG

2 inhalations as a single dose

Charcoal and Budesonide/formoterol EH

Group Type EXPERIMENTAL

budesonide and formoterol 200/6 microg

Intervention Type DRUG

2 inhalations as a single dose with the concurrent charcoal blockage

Symbicort Turbohaler

Group Type ACTIVE_COMPARATOR

budesonide and formoterol 200/6 microg

Intervention Type DRUG

2 inhalations as a single dose

Charcoal and Symbicort Turbohaler

Group Type ACTIVE_COMPARATOR

budesonide and formoterol 200/6 microg

Intervention Type DRUG

2 inhalations as a single dose with the concurrent charcoal blockage

Interventions

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budesonide and formoterol 200/6 microg

2 inhalations as a single dose

Intervention Type DRUG

budesonide and formoterol 200/6 microg

2 inhalations as a single dose

Intervention Type DRUG

budesonide and formoterol 200/6 microg

2 inhalations as a single dose with the concurrent charcoal blockage

Intervention Type DRUG

budesonide and formoterol 200/6 microg

2 inhalations as a single dose with the concurrent charcoal blockage

Intervention Type DRUG

Other Intervention Names

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Budesonide/formoterol Easyhaler 200/6 microg/inhalation Symbicort Turbohaler 200/6 microg/inhalation Budesonide/formoterol Easyhaler 200/6 microg/inhalation Symbicort Turbohaler 200/6 microg/inhalation

Eligibility Criteria

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Inclusion Criteria

* Males or females aged 18-60 years with documented diagnosis of asthma
* Prebronchodilator forced expiratory volume in one second (FEV1) at least 80% of the predicted value
* The asthma should be stable on the same regular treatment for at least 4 weeks before screening.

Exclusion Criteria

* Use of oral, parenteral or rectal corticosteroids within 4 weeks preceding the screening
* Respiratory infection within 4 weeks preceding the screening
* Any condition requiring regular concomitant treatment or likely to need concomitant treatment during the study with medicinal products which have pharmacokinetic interactions with budesonide
* Any disorder or clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No