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

Basic Information

• 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

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

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

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

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

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

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zeynep Misirligil

Role: PRINCIPAL_INVESTIGATOR

Ankara Univ. Med. Fac, Chest Disease Dept

Locations

Research Site

Ankara, , Turkey (Türkiye)

Research Site

Antalya, , Turkey (Türkiye)

Research Site

Bursa, , Turkey (Türkiye)

Research Site

Denizli, , Turkey (Türkiye)

Research Site

Diyarbakır, , Turkey (Türkiye)

Research Site

Edirne, , Turkey (Türkiye)

Research Site

Eski?ehir, , Turkey (Türkiye)

Research Site

Istanbul, , Turkey (Türkiye)

Research Site

Izmir, , Turkey (Türkiye)

Research Site

Kocaeli, , Turkey (Türkiye)

Research Site

Malatya, , Turkey (Türkiye)

Research Site

Manisa, , Turkey (Türkiye)

Research Site

Mersin, , Turkey (Türkiye)

Research Site

Samsun, , Turkey (Türkiye)

Research Site

Zonguldak, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

D5890L00016

Identifier Type: -

Identifier Source: org_study_id