Study of Safety of Foradil in Patients with Persistent Asthma


About this study

The purpose of this study is 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 is the same as those taking inhaled fluticasone propionate alone.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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)

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).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Gerald Volcheck, M.D.

Closed for enrollment

More information


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