Phase 3
N=605
Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX® Inhalation Powder Versus SYMBICORT® TURBOHALER®
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01803555 ↗Enrolled (actual)
605
Serious AEs
0.7%
Results posted
Dec 2023
Primary outcome: Primary: Change From Baseline in Weekly Average of Daily Trough (Predose and Pre-rescue Bronchodilator) Morning (AM) Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period — 18.839; 21.796 liters (L)/minute (min) — p=0.3387
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Budesonide/Formoterol SPIROMAX® (Drug); SYMBICORT® TURBOHALER® (Drug); SYMBICORT placebo (Drug); SPIROMAX Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Weekly Average of Daily Trough (Predose and Pre-rescue Bronchodilator) Morning (AM) Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period |
18.839; 21.796 | 0.3387 |
| SECONDARY Change From Baseline in Weekly Average of Daily Evening (PM) PEF Over the 12-Week Treatment Period |
18.661; 21.740 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
117; 106 | — |
| SECONDARY Number of Participants With Signs of Oral Candidiasis (Thrush) |
0; 0; 1; 0; 1; 2 | — |
| SECONDARY Number of Participants With Positive Swab of Oral Candidiasis (Thrush) |
1; 0; 0; 0; 0; 0 | — |
Summary
The primary objective of the study is to establish whether budesonide/formoterol fumarate dihydrate (BF) Spiromax 160/4.5 micrograms (mcg) is as effective as Symbicort Turbohaler 200/6 mcg administered twice daily in participants with persistent asthma.
Eligibility Criteria
Inclusion Criteria
- Male or female participants 12 years and older as of the screening visit. Male or female participants 18 years and older, as of the screening visit, in countries where local regulations or the regulatory status of study medication permit enrollment of adult participants only.
- General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the participant at increased risk during the study.
- Asthma Diagnosis: The asthma diagnosis must be in accordance with the Global Initiative for Asthma (GINA)
Exclusion Criteria
- History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
- Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks before the screening visit. In addition, the participant must be excluded if such infection occurs between the screening visit and the baseline visit.
- Any asthma exacerbation requiring oral corticosteroids within 1 month of the screening visit. A participant must not have been hospitalized for asthma within 6 months before the screening visit.
- Presence of glaucoma, cataracts, ocular herpes simplex, or malignancy other than basal cell carcinoma.
- Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular conditions (for example, congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine conditions (for example, uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), gastrointestinal conditions (for example, poorly-controlled peptic ulcer, gastroesophageal reflux disease [GERD]), or pulmonary conditions (for example, chronic bronchitis, emphysema, bronchiectasis with the need for treatment, cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition became exacerbated during the study.
NOTE: Other inclusion and exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01803555). 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.