A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma (PASSION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00628758
First received: January 10, 2008
Last updated: July 6, 2012
Last verified: July 2012

January 10, 2008
July 6, 2012
December 2005
September 2008   (final data collection date for primary outcome measure)
Time to First Severe Asthma Exacerbation [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Time to severe exacerbation among patients
Time to first severe asthma exacerbation. Defined as deterioration in asthma leading to at least one of the following:1. Hospitalisation/Emergency room (or equivalent) treatment due to asthma 2. Oral GC treatment due to asthma for at least 3 days
Complete list of historical versions of study NCT00628758 on ClinicalTrials.gov Archive Site
  • 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
  • Number of severe asthma exacerbations
  • Change in AQLQ(S) score from randomisation (visit 1) to Visits 4
  • Mean use of as-needed medication per day during treatment period
  • Prescribed asthma medication during the treatment period
Not Provided
Not Provided
 
A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma
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.

A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler Therapy in adult patients with persistent asthma.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
  • Drug: Symbicort TBH - Turbuhaler
    Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
  • 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:
    • 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
  • Experimental: Symbicort
    Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
    Intervention: Drug: Symbicort TBH - Turbuhaler
  • Experimental: Conventional BP
    Conventional Best Practice for Treatment of Asthma
    Intervention: Drug: beta-II-agonist, inhale steroid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
430
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT00628758
D5890L00016
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Zeynep Misirligil Ankara Univ. Med. Fac, Chest Disease Dept
AstraZeneca
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP