Study to investigate real life effectiveness of Symbicort Maintenance and Reliever Therapy in Asthma patients across Asia.

Phase 4

Completed

• Conditions: Other and unspecified asthma,

• Registration Number: CTRI/2009/091/000562
• Lead Sponsor: AstraZeneca Singapore Pte Ltd

Brief Summary

The propose of this study is to compare whether Symbicort Maintence & Reliever Therapy (SMART) is more effective in uncontrolled asthmatic patients than their current therapy in a real life situation. Of 1150 patients planned regionally for the study, India enrolled 176 patients in the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-18
• Study Completion: 2010-07-14
• Last Update Posted: 2020-05-16

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1150

Inclusion Criteria

• Provision of signed informed consent.
• Asthma diagnosis at least 6 months before visit 1 of study.
• Patients who have reversible airway obstruction continuous asthma treatment except Symbicort at least within 4 weeks before visit 1 of study.

Exclusion Criteria

Known or suspected allergy to active ingredients of study medication or excipients- Use of oral, rectal or parenteral glucocorticosteroids 30 days before visit 1 of study- Smoking, current or previous with a smoking history of ≥10 pack years.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Asthma Control Questionnaire (ACQ(5)) score from baseline at a regional level	At initiate study treatment visit with 3 further visits at 4, 8 and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in ACQ (5) score from baseline at country level	At initiate study treatment visit with 3 further visits at 4, 8 and 12 weeks
Change in Asthma Quality of Life Questionnaire, standardized version (AQLQ (S)) domain and overall scores from baseline	At initiate study treatment visit with 3 further visits at 4, 8 and 12 weeks
Study medication use (maintenance and reliever) in Diary Cards	At initiate study treatment visit with 2 further visits at 4 and 8 weeks

Trial Locations

Locations (12)

Bangalore Clinisearch; 🇮🇳 Bangalore, KARNATAKA, India

Bengaluru Allergy & Immunology Research Foundation; 🇮🇳 Compound,Mission, India

Coimbatore Chest Clinic; 🇮🇳 Coimbatore, TAMIL NADU, India

Dr. Mehta's Allergy and Asthma Care and Research Centre; 🇮🇳 Indore, MADHYA PRADESH, India

Fortis Hospital; 🇮🇳 Sector, India

Global Hospitals and Health City; 🇮🇳 Chennai, TAMIL NADU, India

Kunal Institute of Medical Specialities Pvt. Ltd.; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Mehta's Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Ramamurthy Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Sri Ramachandra Medical Center; 🇮🇳 Chennai, TAMIL NADU, India

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Bangalore Clinisearch

🇮🇳Bangalore, KARNATAKA, India

Dr. S. Dinesh

Principal investigator

bhaktha.dinesh@gmail.com