Phase 3
Completed N=11,693
A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents
Source: ClinicalTrials.gov NCT01444430 ↗Enrolled (actual)
11,693
Serious AEs
2.1%
Results posted
Dec 2016
Primary outcomePrimary: Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) — 43; 40 Participants
◆ Published Evidence
Highly cited
108citations · ~11 / year
Serious Asthma Events with Budesonide plus Formoterol vs. Budesonide Alone.
Summary
The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma
Linked Publications
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Serious Asthma Events with Budesonide plus Formoterol vs. Budesonide Alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) |
43; 40 | — |
| PRIMARY Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation |
539; 633 | 0.002 sig |
| SECONDARY Percent of Days With no Asthma Symptoms |
81.1; 76.8 | <0.001 sig |
| SECONDARY Percent of Days With Activity Limitation Due to Asthma |
19.7; 19.1 | 0.272 |
| SECONDARY Mean Number of Puffs of Rescue Medication Per 24 Hours |
0.8; 0.9 | <0.001 sig |
| SECONDARY Asthma Control Questionnaire (ACQ6) |
-0.70; -0.62 | <0.001 sig |
| SECONDARY Percent of Nights With Awakening(s) Due to Asthma |
4.0; 4.7 | 0.004 sig |
| SECONDARY Number of Participants Experiencing Discontinuation of Investigational Product Due to a Protocol Defined Asthma Exacerbation |
53; 71 | 0.095 |
Eligibility Criteria
Inclusion Criteria
- Provision of signed informed consent/ paediatric assent (if applicable) prior to any study specific procedures including medication withdrawal
- Male or Female, ≥12 years of age
- Documented clinical diagnosis of asthma for at least 1 year prior to Visit 2
- Patient must have history of at least 1 asthma exacerbation including one of the following:
- requiring treatment with systemic corticosteroids
- an asthma-related hospitalization between 4 weeks and 12 months prior to randomization
- Current Asthma Therapy: Patients must be appropriately using one of the treatments for asthma listed in the protocol combined with achieving certain results when recording an Asthma Control Questionnaire
Exclusion Criteria
- Patient has a history of life-threatening asthma. Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support.
- Patient has required treatment with systemic corticosteroids (tablets, suspensions or injectable) for any reason within 4 weeks prior to Visit 2
- Patient has an ongoing exacerbation, defined as a worsening of asthma that requires treatment with systemic corticosteroids (tablets, suspension, or injectable)
- An asthma exacerbation within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization or more than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
- Patient has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 2 that, in the investigator's opinion, will interfere with the patient's lung function
- Patient must not meet unstable asthma severity criteria as listed in the protocol
- Peak expiratory flow must not be below 50% o predicted normal
- Pregnancy, breast-feeding or planned pregnancy during the study
Data sourced from ClinicalTrials.gov (NCT01444430) 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.