Symbicort Rapihaler Therapeutic Equivalence Study

NCT ID: NCT00536731

Last Updated: 2012-08-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

742 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bronchial Asthma

Keywords

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Asthma Symbicort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Symbicort pMDI

Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily

Group Type ACTIVE_COMPARATOR

Symbicort pMDI

Intervention Type DRUG

Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily

Symbicort Turbuhaler

Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily

Group Type ACTIVE_COMPARATOR

Symbicort Turbuhaler

Intervention Type DRUG

Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily

Pulmicort Turbuhaler

Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily

Group Type ACTIVE_COMPARATOR

Pulmicort Turbuhaler

Intervention Type DRUG

Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily

Interventions

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Symbicort Turbuhaler

Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily

Intervention Type DRUG

Symbicort pMDI

Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily

Intervention Type DRUG

Pulmicort Turbuhaler

Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 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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Tomas Andersson

Role: STUDY_DIRECTOR

AstraZeneca

Akos Somoskovi

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca

Locations

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Research Site

Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Benesov U Prahy, , Czechia

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Hradec Králové, , Czechia

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Jihlava, , Czechia

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Kladno, , Czechia

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Kolín, , Czechia

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Kutná Hora, , Czechia

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Litoměřice, , Czechia

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Neratovice, , Czechia

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Pardubice, , Czechia

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Prague, , Czechia

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Rokycany, , Czechia

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Strakonice, , Czechia

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Balassagyarmat, , Hungary

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Budapest, , Hungary

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Cegléd, , Hungary

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Debrecen, , Hungary

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Deszk, , Hungary

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Győr, , Hungary

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Gyula, , Hungary

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Kaposvár, , Hungary

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Nyíregyháza, , Hungary

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Szarvas, , Hungary

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Százhalombatta, , Hungary

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Szeged, , Hungary

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Törökbálint, , Hungary

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Bialystok, , Poland

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Bielsko-Biala, , Poland

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Bydgoszcz, , Poland

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Chodzież, , Poland

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Chrzanów, , Poland

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Karpacz, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Ostrów Wielkopolski, , Poland

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Poznan, , Poland

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Skierniewice, , Poland

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Szczecin, , Poland

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Tarnów, , Poland

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Turek, , Poland

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Wodzisław Śląski, , Poland

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Wroclaw, , Poland

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Łomża, , Poland

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Countries

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Bulgaria Czechia Hungary Poland

Other Identifiers

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D5897C00003

Identifier Type: -

Identifier Source: org_study_id