Study of Safety of Foradil in Patients With Persistent Asthma
Condition: Persistent Asthma
MeSH terms: Asthma
Intervention: Formoterol 12 mcg; Fluticasone propionate 100 mcg; Fluticasone propionate 250 mcg; Fluticasone propionate 500 mcg; Placebo
Intervention description: Formoterol 12 mcg one inhalation twice daily, via dry powder inhaler; Fluticasone propionate 100 mcg one inhalation twice daily via dry powder inhaler; Fluticasone propionate 250 mcg one inhalation twice daily via dry powder inhaler; Fluticasone propionate 500 mcg, one inhalation twice daily via dry powder inhaler; Placebo to match formoterol one inhalation twice daily via dry powder inhaler
Intervention MeSH terms: Fluticasone; Xhance; Formoterol Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 827.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Asthma; formoterol fumarate; Foradil; inhaled corticosteroid; fluticasone propionate; safety

Summary:

      The purpose of this study was to assess whether the risk of serious asthma-related events
      (asthma-related hospitalizations, asthma related intubations, and asthma related deaths) in
      adolescents and adults (12 years of age and older) taking inhaled formoterol
      fumarate/fluticasone propionate combination was the same as those taking inhaled fluticasone
      propionate alone.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Written informed consent, and assent if applicable, must be obtained before any
             assessment is performed.

          2. Male or female patients 12 years of age and older

          3. Confirmed diagnosis of persistent asthma, as defined by national and international
             asthma guidelines (e.g., GINA; NIH; etc.) for at least 1 year prior to study
             enrollment.

          4. PEF≥50% of predicted normal value.

          5. Current and appropriate use of one of the treatments listed in the protocol for
             asthma.

          6. Recent asthma exacerbation between 30 days and 12 months prior to randomization that
             either:

               -  required treatment with systemic corticosteroids (tablets, suspension, or
                  injection) or

               -  required hospitalization (defined as an inpatient stay or >24-hour stay in an
                  observation area in an emergency room or other equivalent facility)

        Key Exclusion Criteria:

          1. History of life-threatening asthma episode that required intubation and/or was
             associated with hypercapnia requiring non-invasive ventilatory support.

          2. Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease,
             allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia,
             or other respiratory abnormalities other than asthma.

          3. Current evidence of, or past physician assessment of, chronic bronchitis, emphysema,
             or chronic obstructive pulmonary disease.

          4. History of smoking ≥ 10 pack years.

          5. Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily
             asthma control medicine.

          6. Suspected or documented bacterial or viral infection of the upper or lower respiratory
             tract, sinus or middle ear that is not resolved at randomization.

          7. Worsening/Unstable asthma within 7 days prior to randomization.

          8. Any asthma exacerbation requiring systemic corticosteroids within 30 days of
             randomization or more than 4 separate exacerbations in the 12 months preceding
             randomization.

          9. Two or more hospitalizations for greater than 24 hours duration for treatment of
             asthma in the 12 months preceding randomization.

         10. History of hypersensitivity to any beta2-agonist, sympathomimetic drug, inhaled
             corticosteroids, or systemic corticosteroid therapy or any component of the possible
             study treatments in this trial, including severe milk protein hypersensitivity.

         11. Use of anti-IgE (e.g., omalizumab) or any other monoclonal antibody, in the 6 months
             prior to randomization.

         12. Use of (Beta) β-blockers within 1 day prior to first dose of study medication.

         13. Use of ICS, LABA, ICS+LABA, LTRAs, leukotriene modifiers, anticholinergics, or
             theophylline must be discontinued prior to the first dose of investigational
             treatment.

         14. Use of a potent CYP3A4 inhibitor within 4 weeks of randomization (e.g., ritonavir,
             atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir,
             saquinavir, ketoconazole, telithromycin).