Overview

This trial is active, not recruiting.

Condition asthma
Treatments budesonide/formoterol 'as needed' + budesonide placebo bid, budesonode bid + terbutaline 'as needed'
Phase phase 3
Sponsor AstraZeneca
Start date November 2014
End date August 2017
Trial size 4114 participants
Trial identifier NCT02224157, 2013-004473-28, D589SC00003

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' + Placebo Pulmicort Turbuhaler 200 μg bid
budesonide/formoterol 'as needed' + budesonide placebo bid
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
(Active Comparator)
Pulmicort 200 μg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed'
budesonode bid + terbutaline 'as needed'
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

Primary Outcomes

Measure
Annual severe asthma exacerbation rate
time frame: up to 52 weeks

Secondary Outcomes

Measure
Time to first severe asthma exacerbation
time frame: up to 52 weeks
Average change from baseline in pre-dose FEV1
time frame: study weeks 0,17, 34, 52
Time to study specific asthma related discontinuation
time frame: up to 52 weeks
Average change from baseline in 'as needed' use
time frame: up to 52 weeks
Change from baseline in percent of 'as needed' free days
time frame: up to 52 weeks
Percentage of controller use days
time frame: up to 52 weeks
Average change from baseline in Asthma Control Questionnaire (5-item version) - ACQ-5 score
time frame: study weeks 0, 17, 34, 52
Average change from baseline in Asthma Quality of Life Questionnaire Standardised Version - AQLQ(S) score
time frame: study weeks 0,17, 34, 52

Eligibility Criteria

Male or female participants from 12 years up to 130 years old.

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

Additional Information

Official title A Clinical Study Comparing Symbicort 'as Needed' With Pulmicort Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma
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) Turbuhaler 160/4.5 μg 'as needed' compared with Pulmicort (budesonide) Turbuhaler 200 μg twice daily plus terbutaline Turbuhaler 0.4 mg 'as needed'
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.