Status:
COMPLETED
Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX® Inhalation Powder Versus SYMBICORT® TURBOHALER®
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 administere...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 4 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2014
Estimated Enrollment :
605 Patients enrolled
Trial Details
Trial ID
NCT01803555
Start Date
July 4 2013
End Date
March 20 2014
Last Update
December 8 2023
Active Locations (114)
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1
Teva Investigational Site 33020
Grieskirchen, Austria, 4710
2
Teva Investigational Site 33019
Linz, Austria, 4020
3
Teva Investigational Site 33018
Wels, Austria, 4600
4
Teva Investigational Site 37029
Gozée, Belgium, 6534