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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
Symbicort TBH - Turbuhaler
beta-II-agonist, inhale steroid
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Symbicort, Turbuhaler, Persistent Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Symbicort

Conventional BP

Arm Description

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

Conventional Best Practice for Treatment of Asthma

Outcomes

Primary Outcome Measures

Time to First Severe Asthma Exacerbation
Time to severe exacerbation among patients

Secondary Outcome Measures

Number of Severe Asthma Exacerbations
Total number of severe asthma exacerbations per treatment group
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.
Mean Use of As-needed Medication Per Day During Treatment Period
Mean use of as-needed medication per day during treatment period

Full Information

First Posted
January 10, 2008
Last Updated
July 6, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00628758
Brief Title
A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Symbicort, Turbuhaler, Persistent Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
430 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Symbicort
Arm Type
Experimental
Arm Description
Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
Arm Title
Conventional BP
Arm Type
Experimental
Arm Description
Conventional Best Practice for Treatment of Asthma
Intervention Type
Drug
Intervention Name(s)
Symbicort TBH - Turbuhaler
Intervention Description
Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
Intervention Type
Drug
Intervention Name(s)
beta-II-agonist, inhale steroid
Other Intervention Name(s)
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
Intervention Description
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
Primary Outcome Measure Information:
Title
Time to First Severe Asthma Exacerbation
Description
Time to severe exacerbation among patients
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Number of Severe Asthma Exacerbations
Description
Total number of severe asthma exacerbations per treatment group
Time Frame
26 weeks
Title
Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score
Description
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.
Time Frame
Baseline and 26 weeks
Title
Mean Use of As-needed Medication Per Day During Treatment Period
Description
Mean use of as-needed medication per day during treatment period
Time Frame
Daily recording during the treatment period of 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep Misirligil
Organizational Affiliation
Ankara Univ. Med. Fac, Chest Disease Dept
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Ankara
Country
Turkey
Facility Name
Research Site
City
Antalya
Country
Turkey
Facility Name
Research Site
City
Bursa
Country
Turkey
Facility Name
Research Site
City
Denizli
Country
Turkey
Facility Name
Research Site
City
Diyarbakir
Country
Turkey
Facility Name
Research Site
City
Edirne
Country
Turkey
Facility Name
Research Site
City
Eski?ehir
Country
Turkey
Facility Name
Research Site
City
Istanbul
Country
Turkey
Facility Name
Research Site
City
Izmir
Country
Turkey
Facility Name
Research Site
City
Kocaeli
Country
Turkey
Facility Name
Research Site
City
Malatya
Country
Turkey
Facility Name
Research Site
City
Manisa
Country
Turkey
Facility Name
Research Site
City
Mersin
Country
Turkey
Facility Name
Research Site
City
Samsun
Country
Turkey
Facility Name
Research Site
City
Zonguldak
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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