A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma

AstraZeneca4,215 enrolled

Overview

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 needed' will be compared with Pulmicort (budesonide) Turbuhaler twice daily plus terbutaline Turbuhaler 'as needed'

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) Turbuhaler 160/4.5 μg 'as needed' compared with Pulmicort (budesonide) Turbuhaler 200 μg twice daily plus terbutaline Turbuhaler 0.4 mg 'as needed'

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

4,215

Conditions

Asthma

Interventions

budesonide/formoterol 'as needed' + budesonide placebo bidDRUG

Symbicort (budesonide/ formoterol) 160/4.5 μg powder for inhalation 'as needed' plus Pulmicort placebo 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment

budesonode bid + terbutaline 'as needed'DRUG

Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment

Eligibility

Sex: ALLMin age: 12 YearsMax age: 130 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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 2. Male or Female, ≥12 years of age 3. Documented diagnosis of asthma for at least 6 months prior to Visit 1 4. Patients who are in need of GINA step 2 treatment 5. 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 6. 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 7. Patients should have reversible airway obstruction 8. 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 Criteria: 1. Patient has a history of life-threatening asthma including intubation and intensive care unit admission 2. 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 3. 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 4. Current or previous smoker with a smoking history of ≥ 10 pack years 5. Pregnancy, breast-feeding or planned pregnancy during the study

Locations (340)

Outcomes

Primary Outcomes

Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis

Severe asthma exacerbations over the randomised treatment period, negative binomial model for non-inferiority test evaluation

Time frame: up to 52 weeks

Annual Severe Asthma Exacerbation Rate - Superiority Analysis

Severe asthma exacerbations over the randomised treatment period, negative binomial model for superiority test evaluation

Time frame: up to 52 weeks

Secondary Outcomes

Number of Participants Experiencing at Least One Severe Asthma Exacerbation

A severe exacerbation is defined as a deterioration of asthma requiring any of the following: use of systemic glucocorticosteroids (GCS) for at least 3 days, inpatient hospitalization, or emergency room visit due to asthma that required systemic steroids.

Time frame: Day 1 up to 52 weeks

Average Change From Baseline in Pre-bronchodilator FEV1

The average change from baseline (baseline defined by measurement at week 0, prior to first dose of IP) to the treatment period average assessed over the entire treatment period in pre-bronchodilator FEV1 was derived by computing a contrast for the mean across the post-randomisation visits (week 17, 34, 52) from the MMRM (mixed model repeated measures) analysis.

Time frame: Study weeks 0,17, 34, 52

Number of Participants With Study Specific Asthma Related Discontinuation

The following two criteria lead to discontinuation from the IP due to asthma related events: A severe asthma exacerbation with duration for more than 3 weeks, and/or three severe asthma exacerbations during 6 months.

Time frame: Day 1 up to 52 weeks

Average Change From Baseline in 'as Needed' Use

Data from ClinicalTrials.gov

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Research Site

Sydney, Australia

Research Site

Botucatu, Brazil

Research Site

Florianópolis, Brazil

Research Site

Goiânia, Brazil

Research Site

Porto Alegre, Brazil

Research Site

Porto Alegre, Brazil

Research Site

Porto Alegre, Brazil

Research Site

Porto Alegre, Brazil

Research Site

Porto Alegre, Brazil

Research Site

Salvador, Brazil

...and 330 more locations