Efficacy of Albuterol SPIROMAX® in Adult and Adolescent Patients With Exercise-Induced Bronchoconstriction (EIB)
Condition: Exercise-Induced Bronchoconstriction (EIB)
Intervention: Albuterol Spiromax; Placebo Spiromax
Intervention description: Albuterol Spiromax is an inhalation-driven, multi-dose dry powder inhaler (DPI) containing a blend of albuterol sulfate with alpha-lactose monohydrate. Each actuation represents a dose of 90 mcg of albuterol sulfate. Participants received one dose of two inhalations (180 mcg).; Placebo Spiromax is an inhalation-driven, multi-dose dry powder inhaler (DPI) delivering placebo to match the experimental drug. Participants received one dose of two inhalations.
Intervention MeSH terms: Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Exercise-Induced Bronchoconstriction (EIB); Spiromax®; Albuterol sulfate

Summary:

      The primary objective of this study is to evaluate the efficacy of a single dose (2
      inhalations, 180 mcg total) of Albuterol SPIROMAX (90 mcg per inhalation) versus placebo in
      patients with EIB.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent/assent: For patients 18 to 50 years of age, inclusive, written
             informed consent signed and dated by the patient before conducting any study related
             procedures and review of Health Insurance Portability and Accountability Act of 1996
             (HIPAA) authorization; for patients 12 to 17 years of age, inclusive, written informed
             consent signed and dated by the parent/legal guardian and written assent signed and
             dated by the patient before conducting any study related procedure and review of HIPAA
             authorization.

          -  Male or female patients 12 to 50 years of age, inclusive, as of SV1.

          -  If female, is currently not pregnant, breastfeeding, or attempting to become pregnant,
             has a negative serum pregnancy test, and is of non-childbearing potential.

          -  Documented history of EIB, with or without underlying asthma. The underlying asthma
             must be well-controlled (in the investigator's judgment) as per the National Asthma
             Education and Prevention Program, Expert Panel Report (NAEPP, EPR-3).

          -  Other criteria apply.

        Exclusion Criteria:

          -  Requires a rescue bronchodilator following the exercise challenge at SV1 for a
             decrease in FEV1 that does not return to within 20% of their pre-exercise challenge
             FEV1 within 30 minutes after administration of the rescue medication.

          -  Pregnant, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in
             vitro fertilization during the study period or for 30 days after the patient's last
             study related visit (for eligible patients only-if applicable).

          -  Participation in any investigational drug trial within the 30 days preceding SV1 or
             planned participation in another investigational drug trial at any time during this
             trial.

          -  A known hypersensitivity to albuterol or any of the excipients in the formulation.

          -  History of severe milk protein allergy.

          -  History of a respiratory infection or disorder (including, but not limited to
             bronchitis, pneumonia, otitis media, acute or chronic sinusitis, influenza, etc) that
             has not resolved within the 2 weeks preceding SV1.

          -  Other criteria apply.