A comparative study of Symbicort® Maintenance and Reliever Therapy (Symbicort Turbuhaler® 160/4.5 mg, one inhalation bid plus as-needed) and Symbicort Turbuhaler 160/4.5 mg, one inhalation bid plus Terbutaline Turbuhaler 0.4 mg/inhalation as-needed, for treatment of asthma.

Phase 3

Completed

• Conditions: Health Condition 1: null- AsthmaHealth Condition 2: J459- Other and unspecified asthma

• Registration Number: CTRI/2009/091/000240
• Lead Sponsor: AstraZeneca R D

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2010-12-21
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 249

Inclusion Criteria

1.Provision of signed and dated informed consent prior to any study specific procedures. For patients under-age, signed informed consent from both the patient and the patient?s parent/legal guardian is required.

2.Outpatients of either gender aged >=16 years

3.Diagnosis of asthma according to GINA 2007 with a documented history of at least 6 months duration prior to start of study

4.FEV1 ³ 50% of predicted normal value pre-bronchodilator

5.Reversible airway obstruction defined as an increase in FEV1 >=12% relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline (delivered dose) Turbuhaler

6.Prescribed use of inhaled GCS (any brand) for at least 12 weeks prior to Visit 2

Exclusion Criteria

Patients must not enter the study if any of the following exclusion criteria are fulfilled.

1.Respiratory infection affecting the asthma, as judged by the investigator, within 4 weeks prior to Visit 2

2.Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS within 12 weeks prior to Visit 2

Study & Design

• Study Type: Interventional
• Study Design: Not specified