Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX® Inhalation Powder Versus SYMBICORT® TURBOHALER®
Condition: Asthma
MeSH terms: Asthma
Intervention: Budesonide/Formoterol SPIROMAX®; SYMBICORT® TURBOHALER®; SYMBICORT placebo; SPIROMAX Placebo
Intervention description: BF Spiromax will be administered per dose and schedule specified in the arm.; Symbicort Turbohaler will be administered per dose and schedule specified in the arm.; SYMBICORT placebo multi-dose dry powder inhaler (DPI) identical in appearance to SYMBICORT TURBOHALER will be administered per dose and schedule specified in the arm.; SPIROMAX Placebo multi-dose dry powder inhaler (DPI) identical in appearance to BF SPIROMAX will be administered per dose and schedule specified in the arm.
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 605.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Budesonide/Formoterol SPIROMAX®; SYMBICORT® TURBOHALER®; Asthma

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.