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

July 6, 2012 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

430

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • 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
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Symbicort
Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
Experimental: Conventional BP
Conventional Best Practice for Treatment of Asthma
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Severe Asthma Exacerbation
Time Frame: 26 weeks
Time to severe exacerbation among patients
26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Severe Asthma Exacerbations
Time Frame: 26 weeks
Total number of severe asthma exacerbations per treatment group
26 weeks
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.
Baseline and 26 weeks
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
Daily recording during the treatment period of 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Zeynep Misirligil, Ankara Univ. Med. Fac, Chest Disease Dept

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

January 10, 2008

First Submitted That Met QC Criteria

February 25, 2008

First Posted (Estimate)

March 5, 2008

Study Record Updates

Last Update Posted (Estimate)

August 14, 2012

Last Update Submitted That Met QC Criteria

July 6, 2012

Last Verified

July 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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