A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma (PASSION)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00628758
First received: January 10, 2008
Last updated: July 6, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Symbicort TBH - Turbuhaler Drug: beta-II-agonist, inhale steroid |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Asthma
Drug Information available for:
Formoterol fumarate
Formoterol
Salmeterol
Salmeterol xinafoate
Arformoterol Tartrate
U.S. FDA Resources
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Time to First Severe Asthma Exacerbation [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Time to severe exacerbation among patients
Secondary Outcome Measures:
- Number of Severe Asthma Exacerbations [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Total number of severe asthma exacerbations per treatment group
- Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Daily recording during the treatment period of 26 weeks ] [ Designated as safety issue: No ]Mean use of as-needed medication per day during treatment period
| Enrollment: | 430 |
| Study Start Date: | December 2005 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Symbicort
Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
|
Drug: Symbicort TBH - Turbuhaler
Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
|
|
Experimental: Conventional BP
Conventional Best Practice for Treatment of Asthma
|
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
Other Names:
|
Detailed Description:
A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler Therapy in adult patients with persistent asthma.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00628758
Locations
| 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, Turkey | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Zeynep Misirligil | Ankara Univ. Med. Fac, Chest Disease Dept |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00628758 History of Changes |
| Other Study ID Numbers: | D5890L00016 |
| Study First Received: | January 10, 2008 |
| Results First Received: | September 18, 2009 |
| Last Updated: | July 6, 2012 |
| Health Authority: | Turkey: Ministry of Health |
Keywords provided by AstraZeneca:
|
Symbicort Turbuhaler Persistent Asthma |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Formoterol Salmeterol Symbicort Adrenergic beta-2 Receptor Agonists |
Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013