- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00628758
A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma (PASSION)
July 6, 2012 updated by: AstraZeneca
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler Therapy in adult patients with persistent asthma.
Study Type
Interventional
Enrollment (Actual)
430
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey
- Research Site
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Antalya, Turkey
- Research Site
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Bursa, Turkey
- Research Site
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Denizli, Turkey
- Research Site
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Diyarbakir, Turkey
- Research Site
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Edirne, Turkey
- Research Site
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Eski?ehir, Turkey
- Research Site
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Istanbul, Turkey
- Research Site
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Izmir, Turkey
- Research Site
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Kocaeli, Turkey
- Research Site
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Malatya, Turkey
- Research Site
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Manisa, Turkey
- Research Site
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Mersin, Turkey
- Research Site
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Samsun, Turkey
- Research Site
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Zonguldak, Turkey
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Symbicort
Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
|
Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
|
Experimental: Conventional BP
Conventional Best Practice for Treatment of Asthma
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to First Severe Asthma Exacerbation
Time Frame: 26 weeks
|
Time to severe exacerbation among patients
|
26 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Severe Asthma Exacerbations
Time Frame: 26 weeks
|
Total number of severe asthma exacerbations per treatment group
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26 weeks
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Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score
Time Frame: Baseline and 26 weeks
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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.
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Baseline and 26 weeks
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Mean Use of As-needed Medication Per Day During Treatment Period
Time Frame: Daily recording during the treatment period of 26 weeks
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Mean use of as-needed medication per day during treatment period
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Daily recording during the treatment period of 26 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zeynep Misirligil, Ankara Univ. Med. Fac, Chest Disease Dept
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
January 10, 2008
First Submitted That Met QC Criteria
February 25, 2008
First Posted (Estimate)
March 5, 2008
Study Record Updates
Last Update Posted (Estimate)
August 14, 2012
Last Update Submitted That Met QC Criteria
July 6, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Salmeterol Xinafoate
- Formoterol Fumarate
- Budesonide, Formoterol Fumarate Drug Combination
Other Study ID Numbers
- D5890L00016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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