A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma - PASSION
Study identifier:D5890L00016
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
asthma
Phase
Phase 3
Healthy volunteers
No
Study drug
Symbicort TBH - Turbuhaler, beta-II-agonist, inhale steroid
Sex
All
Actual Enrollment
430
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Dec 2005
Primary Completion Date: 01 Sept 2008
Study Completion Date: 01 Sept 2008
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 Name: Astmerol inh 25 mcg/dosage, 60-120 dosage Other Name: Astmerol maksihaler 50 mcg/dosage, 28-60 dosage Other Name: Serevent diskus 50 mcg/dosage, 60 dosage Other Name: Serevent inh 25 mcg/dosage, 60 dosage Other Name: Foradil inh kap 12 mcg/dosage, 60 caps Other Name: Foradil inh 12 mcg/dosage, 50-100 dosage Other Name: Foradil combi 200 mcg Other Name: Foradil combi 400 mcg Other Name: Oxis turbuhaler 4.5-9 mcg/dosage, 60 dosage Other Name: Ventofor 12mg/60 inh.caps Other Name: Seretide disc 100-250-500 mcg/dosage 60 dosage Other Name: Symbicort 160/4.5 mcg/60-120 dosage, 320/9mcg/60 dosage |
Contacts
Investigators
Principal Investigator
Zeynep Misirligil
Ankara Univ. Med. Fac, Chest Disease Dept
