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A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma

NCT ID: NCT00628758

Last Updated: 2012-08-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

430 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-09-30

Brief Summary

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The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adult patients with persistent asthma.

Detailed Description

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A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler Therapy in adult patients with persistent asthma.

Conditions

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Asthma

Keywords

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Symbicort Turbuhaler Persistent Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Symbicort

Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)

Group Type EXPERIMENTAL

Symbicort TBH - Turbuhaler

Intervention Type DRUG

Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)

Conventional BP

Conventional Best Practice for Treatment of Asthma

Group Type EXPERIMENTAL

beta-II-agonist, inhale steroid

Intervention Type DRUG

Salbulin inh. 200-400 dosage 100 microgram (mcg)/dosage Salbutamol Sustained Release(SR)capsule 4 mg/8 mg Salbutol tablet (tb) 2 mg Salbutol forte syrup 2 mg/5 ml Ventolin tb, syrup, intravenous(IV),5mgx10 ampule(amp) Ventolin inhaler (inh) 200 dosage, 100 mcg/dosage Ventolin nebul 2.5 mg Volmax tb 4 mg/8 mg Vent-o-sal inh 100 mcg/200 dosage Combivent inh 100 mcg/dosage Combivent neb 2.5 mg/dosage Bricanyl tb 2.5 mg Bricanyl durules ret tb 5 mg Bricanyl syrup 30mg Bricanyl inhaler 0.25 mg/dosage, 400 dosage Bricanyl turbuhaler 0.5 mg/dosage, 200dosage

Interventions

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Symbicort TBH - Turbuhaler

Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)

Intervention Type DRUG

beta-II-agonist, inhale steroid

Salbulin inh. 200-400 dosage 100 microgram (mcg)/dosage Salbutamol Sustained Release(SR)capsule 4 mg/8 mg Salbutol tablet (tb) 2 mg Salbutol forte syrup 2 mg/5 ml Ventolin tb, syrup, intravenous(IV),5mgx10 ampule(amp) Ventolin inhaler (inh) 200 dosage, 100 mcg/dosage Ventolin nebul 2.5 mg Volmax tb 4 mg/8 mg Vent-o-sal inh 100 mcg/200 dosage Combivent inh 100 mcg/dosage Combivent neb 2.5 mg/dosage Bricanyl tb 2.5 mg Bricanyl durules ret tb 5 mg Bricanyl syrup 30mg Bricanyl inhaler 0.25 mg/dosage, 400 dosage Bricanyl turbuhaler 0.5 mg/dosage, 200dosage

Intervention Type DRUG

Other Intervention Names

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Astmerol inh 25 mcg/dosage, 60-120 dosage Astmerol maksihaler 50 mcg/dosage, 28-60 dosage Serevent diskus 50 mcg/dosage, 60 dosage Serevent inh 25 mcg/dosage, 60 dosage Foradil inh kap 12 mcg/dosage, 60 caps Foradil inh 12 mcg/dosage, 50-100 dosage Foradil combi 200 mcg Foradil combi 400 mcg Oxis turbuhaler 4.5-9 mcg/dosage, 60 dosage Ventofor 12mg/60 inh.caps Seretide disc 100-250-500 mcg/dosage 60 dosage Symbicort 160/4.5 mcg/60-120 dosage, 320/9mcg/60 dosage

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent form. If the patient cannot read and write, verbal consent from the patient is required.
* Ability to read and write in Turkish
* Female or male outpatients aged 18 years
* Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition
* Prescribed inhaled glucocorticosteroid (GCS) at a dose of 320mg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1
* Either: daily maintenance treatment with both inhaled GCS and long-acting b2-agonist (LABA) or daily treatment with inhaled GCS alone (i.e. without LABA); and a history of suboptimal asthma control the month prior to enrollment as judged by the investigator; and use of 3 Peak Expiratory Flow inhalations ofas needed medication for symptom relief during the last 7 days before enrollment

Exclusion Criteria

* Previous treatment with Symbicort Single inhaler Therapy
* Use of any b-blocking agent, including eye drops
* Use of oral GCS as maintenance treatment
* Known or suspected hypersensitivity to study therapy or excipients
* A history of smoking 10 pack years
* Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
* Any significant disease or disorder, which, in the opinion of the investigator, may put the patient at risk because of participating in the study
Minimum Eligible Age

18 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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Zeynep Misirligil

Role: PRINCIPAL_INVESTIGATOR

Ankara Univ. Med. Fac, Chest Disease Dept

Locations

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Research Site

Ankara, , Turkey (Türkiye)

Site Status

Research Site

Antalya, , Turkey (Türkiye)

Site Status

Research Site

Bursa, , Turkey (Türkiye)

Site Status

Research Site

Denizli, , Turkey (Türkiye)

Site Status

Research Site

Diyarbakır, , Turkey (Türkiye)

Site Status

Research Site

Edirne, , Turkey (Türkiye)

Site Status

Research Site

Eski?ehir, , Turkey (Türkiye)

Site Status

Research Site

Istanbul, , Turkey (Türkiye)

Site Status

Research Site

Izmir, , Turkey (Türkiye)

Site Status

Research Site

Kocaeli, , Turkey (Türkiye)

Site Status

Research Site

Malatya, , Turkey (Türkiye)

Site Status

Research Site

Manisa, , Turkey (Türkiye)

Site Status

Research Site

Mersin, , Turkey (Türkiye)

Site Status

Research Site

Samsun, , Turkey (Türkiye)

Site Status

Research Site

Zonguldak, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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D5890L00016

Identifier Type: -

Identifier Source: org_study_id