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

Asthma Clinical Trial

— PASSION  

Official title:

A Comparison of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5mg, 1 Inhalation Two Times a Day (b.i.d.) Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults a -26-week, Randomized, Open-label, Parallel-group, Multicentre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628758
• Other study ID #: D5890L00016
• Status: Completed
• Phase: Phase 3
• First received: January 10, 2008
• Last updated: July 6, 2012
• Start date: December 2005
• Est. completion date: September 2008

Study information

• Verified date: July 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Symbicort TBH - Turbuhaler
Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
• 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

Locations

Country	Name	City	State
Turkey	Research Site	Ankara
Turkey	Research Site	Antalya
Turkey	Research Site	Bursa
Turkey	Research Site	Denizli
Turkey	Research Site	Diyarbakir
Turkey	Research Site	Edirne
Turkey	Research Site	Eski?ehir
Turkey	Research Site	Istanbul
Turkey	Research Site	Izmir
Turkey	Research Site	Kocaeli
Turkey	Research Site	Malatya
Turkey	Research Site	Manisa
Turkey	Research Site	Mersin
Turkey	Research Site	Samsun
Turkey	Research Site	Zonguldak

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Severe Asthma Exacerbation	Time to severe exacerbation among patients	26 weeks	No
Secondary	Number of Severe Asthma Exacerbations	Total number of severe asthma exacerbations per treatment group	26 weeks	No
Secondary	Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score	Quality-of-Life assessment; grouped in four domains;activity limitation, symptoms, emotional function and exposure to environmental stimuli, using with a scale from 1 to 7 where 1 represents the greatest possible impairment and 7 represents the least impairment.	Baseline and 26 weeks	No
Secondary	Mean Use of As-needed Medication Per Day During Treatment Period	Mean use of as-needed medication per day during treatment period	Daily recording during the treatment period of 26 weeks	No