Efficacy of Albuterol SPIROMAX® in Adult and Adolescent Patients With Exercise-Induced Bronchocon… (NCT01791972) | Clinical Trial Compass
CompletedPhase 3
Efficacy of Albuterol SPIROMAX® in Adult and Adolescent Patients With Exercise-Induced Bronchoconstriction (EIB)
United States38 participantsStarted 2013-03
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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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 …
What they're measuring
1
Maximum Percentage Fall From Baseline in Forced Expiratory Volume in 1 Second (FEV1) up to 60 Minutes After the Exercise Challenge
Timeframe: Days 1 and 7; up to 60 minutes post-exercise challenge
Trial details
NCT IDNCT01791972
SponsorTeva Branded Pharmaceutical Products R&D, Inc.