Phase 3
Completed N=4,189
A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma
Source: ClinicalTrials.gov NCT02224157 ↗Enrolled (actual)
4,189
Serious AEs
3.3%
Results posted
Nov 2019
Primary outcomePrimary: Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis — 0.11; 0.12 exacerbations per participant year
◆ Published Evidence
Highly cited
511citations · ~64 / year
As-Needed Budesonide-Formoterol versus Maintenance Budesonide in Mild Asthma.
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'
Linked Publications (4)
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As-Needed Budesonide-Formoterol versus Maintenance Budesonide in Mild Asthma.
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Should recommendations about starting inhaled corticosteroid treatment for mild asthma be based on symptom frequency: a post-hoc efficacy analysis of the START study.
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The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given 'as needed' in mild asthma: study protocols for two randomised controlled trials.
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Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis |
0.11; 0.12 | — |
| PRIMARY Annual Severe Asthma Exacerbation Rate - Superiority Analysis |
0.11; 0.12 | 0.754 |
| SECONDARY Number of Participants Experiencing at Least One Severe Asthma Exacerbation |
177; 184 | 0.664 |
| SECONDARY Average Change From Baseline in Pre-bronchodilator FEV1 |
104.0; 136.6 | 0.003 sig |
| SECONDARY Number of Participants With Study Specific Asthma Related Discontinuation |
0; 4 | — |
| SECONDARY Average Change From Baseline in 'as Needed' Use |
-0.84; -0.87 | — |
| SECONDARY Change From Baseline in Percent of 'as Needed' Free Days |
41.01; 47.86 | < 0.001 sig |
| SECONDARY Percentage of Controller Use Days |
30.45; 67.92 | <0.001 sig |
| SECONDARY Average Change From Baseline in Asthma Control Questionnaire (5-item Version) - ACQ-5 Score |
-0.35; -0.46 | <0.001 sig |
| SECONDARY Average Change From Baseline in Asthma Quality of Life Questionnaire Standardised Version - AQLQ(S) Score |
0.335; 0.431 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02224157) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.