A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma
PASSION
1 other identifier
interventional
430
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Dec 2005
Typical duration for phase_3 asthma
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 10, 2008
CompletedFirst Posted
Study publicly available on registry
March 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
August 14, 2012
CompletedAugust 14, 2012
July 1, 2012
2.8 years
January 10, 2008
September 18, 2009
July 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to First Severe Asthma Exacerbation
Time to severe exacerbation among patients
26 weeks
Secondary Outcomes (3)
Number of Severe Asthma Exacerbations
26 weeks
Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score
Baseline and 26 weeks
Mean Use of As-needed Medication Per Day During Treatment Period
Daily recording during the treatment period of 26 weeks
Study Arms (2)
Symbicort
EXPERIMENTALSymbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
Conventional BP
EXPERIMENTALConventional Best Practice for Treatment of Asthma
Interventions
Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (15)
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)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Zeynep Misirligil
Ankara Univ. Med. Fac, Chest Disease Dept
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2008
First Posted
March 5, 2008
Study Start
December 1, 2005
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
August 14, 2012
Results First Posted
August 14, 2012
Record last verified: 2012-07