Phase 3
Completed N=3,836
A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma.
Source: ClinicalTrials.gov NCT02149199 ↗Enrolled (actual)
3,836
Serious AEs
3.3%
Results posted
Sep 2019
Primary outcomePrimary: 'Well-controlled Asthma Week' - a Derived Binary Variable (Yes/No) — 34.4; 31.1; 44.4 Percentage — p=0.046
◆ Published Evidence
Highly cited
632citations · ~79 / year
Inhaled Combined Budesonide-Formoterol as Needed 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: 1) terbutaline Turbuhaler® 'as needed' and with 2) Pulmicort (budesonide) Turbuhaler® twice daily plus terbutaline Turbuhaler® 'as needed'.
Linked Publications (5)
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Inhaled Combined Budesonide-Formoterol as Needed 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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Effect of a single day of increased as-needed budesonide-formoterol use on short-term risk of severe exacerbations in patients with mild asthma: a post-hoc analysis of the SYGMA 1 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 'Well-controlled Asthma Week' - a Derived Binary Variable (Yes/No) |
34.4; 31.1; 44.4 | 0.046 sig |
| SECONDARY Number of Participants Experiencing at Least One Severe Asthma Exacerbation |
71; 152; 78 | <0.001 sig |
| SECONDARY Number of Participants Experiencing at Least One Moderate or Severe Asthma Exacerbation |
131; 274; 143 | <0.001 sig |
| SECONDARY Average Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) |
65; 11.2; 119.3 | <0.001 sig |
| SECONDARY Average Change From Baseline in Morning Peak Expiratory Flow (PEF) |
-3.97; -15.92; 6.01 | <0.001 sig |
| SECONDARY Average Change From Baseline in Evening PEF |
-11.20; -22.15; -4.97 | <0.001 sig |
| SECONDARY Average Change From Baseline in Number of Inhalations of 'as Needed' Medication. |
-0.95; -0.82; -1.06 | — |
| SECONDARY Average Change From Baseline in Asthma Symptom Score |
-0.23; -0.11; -0.32 | <0.001 sig |
| SECONDARY Change From Baseline in the Percentage of Nighttime Awakenings Due to Asthma |
-7.5; -4.6; -9.8 | — |
| SECONDARY Change From Baseline in Percentage of Symptom-free Days |
4.2; 1.3; 6.8 | — |
| SECONDARY Change From Baseline in Percentage of 'As Needed' Free Days |
44.2; 45.0; 51.7 | — |
| SECONDARY Change From Baseline in Percentage of Asthma Control Days |
13.2; 12.8; 18.5 | — |
| SECONDARY Number of Patients With Study Specific Asthma Related Discontinuation |
4; 21; 6 | — |
| SECONDARY Poorly Controlled Asthma Weeks |
7.7; 9.7; 6.7 | — |
| SECONDARY Number of Participants Experiencing at Least One Occasion With Additional Steroids for Asthma |
164; 345; 187 | <0.001 sig |
| SECONDARY Average Change From Baseline in Asthma Control Questionnaire (ACQ-5) |
-0.33; -0.17; -0.48 | <0.001 sig |
| SECONDARY Average Change From Baseline in Asthma Quality of Life Questionnaire; Standard Version (AQLQ(S)) |
0.313; 0.186; 0.415 | <0.001 sig |
| SECONDARY Percentage of Controller Use Days |
30.8; 5.6; 85.6 | — |
| SECONDARY Annual Severe Asthma Exacerbation Rate |
0.07; 0.20; 0.09 | <0.001 sig |
| SECONDARY Annual Moderate or Severe Asthma Exacerbation Rate |
0.14; 0.36; 0.15 | <0.001 sig |
Eligibility Criteria
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 Step 2 treatment according to Global Initiative for Asthma guidelines 5. Patients treated with 'as needed' inhaled short-acting bronchodilator(s) only should have pre-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥ 60 % of Predicted Normal (PN) and post-bronchodilator FEV1 ≥ 80 % PN 6. Patients treated with low stable dose of inhaled corticosteroid or leukotriene antagonist in addition to 'as needed' use of inhaled short-acting 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 inhaled short-acting bronchodilator(s) within 30 days prior to Visit 1 or between Visits 1 and 2; or a treatment other than Bricanyl Turbuhaler from Visit 2 until randomization 3. Patient has required treatment with oral, rectal or parenteral glucocorticosteroids (GCS) within 30 days and/or depot parenteral GCS within 12 weeks prior to Visit 1 4. Smoker (current or previous) with a smoking history of ≥ 10 pack years 5. Pregnancy, breast-feeding or planned pregnancy during the study.
Data sourced from ClinicalTrials.gov (NCT02149199) 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.