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Symbicort Rapihaler Therapeutic Equivalence Study | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Symbicort Rapihaler Therapeutic Equivalence Study

A 6-week, Phase III, Double-blind, Randomized, Multi-centre, Parallel-group Study Evaluating the Efficacy and Safety of 2 Actuations Symbicort®pMDI® 40/2.25 μg Twice Daily Compared With 1 Inhalation Symbicort Turbuhaler® 80/4.5 μg Twice Daily and 1 Inhalation Pulmicort®Turbuhaler® 100 μg Twice Daily

NCT00536731•AstraZeneca

View on ClinicalTrials.gov

Summary

The purpose of the this study is to evaluate the efficacy and safety of 2 actuations Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Asthma clinically diagnosed since at least 6 months.
•Lung function values measured ≥ 50% and ≤ 90% of predicted normal.
•Patients with reversible airway obstruction Daily use of inhaled steroids (any brand) for \>3 months.

Exclusion Criteria

•Use of oral, rectal or parenteral steroids within 30 days prior to start of study.
•Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to start of randomised treatment.
•Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study or the patient's ability to participate in the study.

Locations (48)

Research Site

Pleven, Bulgaria

Research Site

Plovdiv, Bulgaria

Research Site

Rousse, Bulgaria

Research Site

Sofia, Bulgaria

Research Site

Varna, Bulgaria

Research Site

Benesov U Prahy, Czechia

Research Site

Hradec Králové, Czechia

Research Site

Jihlava, Czechia

Research Site

Kladno, Czechia

Research Site

Kolín, Czechia

Key Dates

Start Date

September 1, 2007

Primary Completion Date

April 1, 2008

Completion Date

April 1, 2008

Last Updated

August 15, 2012

Enrollment

742

ACTUAL participants

Conditions

Bronchial Asthma

Interventions

Symbicort Turbuhaler

DRUG

Symbicort pMDI

DRUG

Pulmicort Turbuhaler

DRUG

Behavioral Changes Among Asthmatic Children in Sohag Universty Hospital

NCT06624735

Bronchial Asthma

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ACTIVE_NOT_RECRUITINGPHASE2

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NCT07054034

Bronchial Asthma

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COMPLETEDPHASE3

BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation in Patients With Stable Mild Asthma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Symbicort Rapihaler Therapeutic Equivalence Study

Inclusion Criteria

Exclusion Criteria

Behavioral Changes Among Asthmatic Children in Sohag Universty Hospital

Study of MG-ZG122 Humanized Monoclonal Antibody in Asthma Subjects

BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation in Patients With Stable Mild Asthma

the Effect of Use of Vit d and Probiotic as a Supplementaition in the Treatment of Bronchial Asthma in Patient Aged 6 to 50 Year and Its Effect in Decrasing Excerbation.

Echo and Electrocardiographic Findings in Children With Bronchial Asthma At Sohag University Hospital

Assessment of Bronchial Asthma Among Patients Attending Sohag University Hospital