Symbicort TBH - Turbuhaler
DrugSymbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
NCT Number: NCT00628758
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Research Site, Ankara, Turkey (Türkiye)
A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler Therapy in adult patients with persistent asthma.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: 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
Time frame: 26 weeks
Time to severe exacerbation among patients
Time frame: 26 weeks
Total number of severe asthma exacerbations per treatment group
Time frame: Baseline and 26 weeks
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: Daily recording during the treatment period of 26 weeks
Mean use of as-needed medication per day during treatment period
AstraZeneca
Industry
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
Acronym: PASSION
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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