Status:
COMPLETED
A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
12-130 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to test if Symbicort (budesonide/formoterol) Turbuhaler is effective in treating asthma when used 'as needed' in patients with milder asthma. The efficacy of Symbicort 'as...
Detailed Description
A 52-week, double-blind, randomised, multi-centre, phase III, parallel-group study in patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort (budesonide/formoterol) T...
Eligibility Criteria
Inclusion
- Provision of 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
- Male or Female, ≥12 years of age
- Documented diagnosis of asthma for at least 6 months prior to Visit 1
- Patients who are in need of GINA step 2 treatment
- Patients treated with a short acting inhaled bronchodilator(s) only should have pre-bronchodilator FEV1 ≥ 60 % of predicted normal (PN) and post-bronchodilator FEV1 ≥ 80 % PN
- Patients treated with low stable dose of ICS or leukotriene antagonists in addition to short acting inhaled bronchodilator(s) should have pre-bronchodilator FEV1 ≥80 % PN
- Patients should have reversible airway obstruction
- To be randomized patients must have used Bricanyl Turbuhaler as needed on at least 3 separate days during the last week of the run in period
Exclusion
- Patient has a history of life-threatening asthma including intubation and intensive care unit admission
- Patient has had an asthma worsening requiring change in treatment other than short acting inhaled bronchodilator(s) within 30 days prior to Visit 1 and from Visit 1 until randomization
- Patient has required treatment with oral, rectal or parenteral GCS within 30 days and/or depot parenteral GCS within 12 weeks prior to Visit 1
- Current or previous smoker with a smoking history of ≥ 10 pack years
- Pregnancy, breast-feeding or planned pregnancy during the study
Key Trial Info
Start Date :
November 28 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2017
Estimated Enrollment :
4215 Patients enrolled
Trial Details
Trial ID
NCT02224157
Start Date
November 28 2014
End Date
August 16 2017
Last Update
November 25 2019
Active Locations (340)
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1
Research Site
Sydney, Australia, 2010
2
Research Site
Botucatu, Brazil, 18618-970
3
Research Site
Florianópolis, Brazil, 88040-970
4
Research Site
Goiânia, Brazil, 74110 030