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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00628758
Recruitment Status : Completed
First Posted : March 5, 2008
Results First Posted : August 14, 2012
Last Update Posted : August 14, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE January 10, 2008
First Posted Date  ICMJE March 5, 2008
Results First Submitted Date  ICMJE September 18, 2009
Results First Posted Date  ICMJE August 14, 2012
Last Update Posted Date August 14, 2012
Study Start Date  ICMJE December 2005
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2012)
Time to First Severe Asthma Exacerbation [ Time Frame: 26 weeks ]
Time to severe exacerbation among patients
Original Primary Outcome Measures  ICMJE
 (submitted: February 25, 2008)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2012)
  • Number of Severe Asthma Exacerbations [ Time Frame: 26 weeks ]
    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 ]
    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 ]
    Mean use of as-needed medication per day during treatment period
Original Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2008)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2012)
430
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2008)
1000
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00628758
Other Study ID Numbers  ICMJE D5890L00016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zeynep Misirligil Ankara Univ. Med. Fac, Chest Disease Dept
PRS Account AstraZeneca
Verification Date July 2012

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