Phase 3
Completed N=214
New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day
Source: ClinicalTrials.gov NCT01360021 ↗Enrolled (actual)
214
Serious AEs
0.5%
Results posted
Mar 2014
Primary outcomePrimary: Forced Expiratory Volume in 1 Second (FEV1) - Post Dose — 2.09; 1.97; 2.12; 2.49 Liter — p=0.001
Summary
This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Expiratory Volume in 1 Second (FEV1) - Post Dose |
2.09; 1.97; 2.12; 2.49; 2.35; 2.28 | 0.001 sig |
| PRIMARY Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose |
2.09; 1.97; 2.12; 2.32; 2.12; 2.22 | — |
| SECONDARY Peak Expiratory Flow |
357.95; 335.70; 360.46; 364.61; 347.86; 367.64 | 0.825 |
| SECONDARY Asthma Symptoms Score (Total) |
2.04; 1.92; 2.12; 1.68; 1.45; 2.02 | 0.272 |
| SECONDARY Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights) |
78.54; 78.76; 81.59; 83.73; 89.93; 84.62 | 0.025 sig |
| SECONDARY Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use) |
2.55; 2.19; 2.65; 1.81; 1.26; 2.34 | 0.258 |
Eligibility Criteria
Inclusion Criteria
- Male or female 12 years and above
- Clinical diagnosis of asthma according to the American Thoracic Society definition at least 6 months
- Pre-bronchodilator FEV1 ≥ 45% and ≤ 85% of predicted normal
- Patients with reversible airway obstruction
- Documented daily use of inhaled corticosteroids for ≥ 3 months
Exclusion Criteria
- History of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures during the 2 years prior to Visit 2
- Hospitalized during previous 6 months for asthma
- Required emergency treatment more than once during previous 6 months for an asthma-related condition
- Intake of oral, rectal or parenteral glucocorticosteroid within 30 days of enrolment
- Respiratory infection affecting the asthma within 30 days
Data sourced from ClinicalTrials.gov (NCT01360021). 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.