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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
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Symbicort TBH - Turbuhaler
Drug: beta-II-agonist, inhale steroid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to First Severe Asthma Exacerbation [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Time to severe exacerbation among patients


Secondary Outcome Measures:
  • 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


Enrollment: 430
Study Start Date: December 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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 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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628758

Locations
Turkey
Research Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Zeynep Misirligil Ankara Univ. Med. Fac, Chest Disease Dept
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00628758     History of Changes
Other Study ID Numbers: D5890L00016
Study First Received: January 10, 2008
Results First Received: September 18, 2009
Last Updated: July 6, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by AstraZeneca:
Symbicort
Turbuhaler
Persistent Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Symbicort
Anti-Asthmatic Agents
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014