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Efficacy of Albuterol SPIROMAX® in Adult and Adolescent Patients With Exercise-Induced Bronchoconstriction (EIB)

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Exercise-Induced Bronchoconstriction (EIB)

Intervention: Albuterol Spiromax (Drug); Placebo Spiromax (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Teva Pharmaceutical Industries

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.

Clinical Details

Official title: A Single-Dose Study to Assess the Efficacy of Albuterol SPIROMAX« in Adult and Adolescent Patients With Exercise-Induced Bronchoconstriction (EIB)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Maximum Percentage Fall From Baseline in Forced Expiratory Volume in 1 Second (FEV1) up to 60 Minutes After the Exercise Challenge

Secondary outcome:

Percentage of Participants Whose Maximum Percentage Decrease From the Baseline Forced Expiratory Volume in 1 Second (FEV1) Post-Exercise Challenge Was <10%

Participants Whose Maximum Percentage Decrease From the Baseline Forced Expiratory Volume in 1 Second (FEV1) Post-Exercise Challenge Was >20%

Detailed description: This study is a single-dose, randomized, double-blind, placebo-controlled, 2-treatment, 2-sequence, 2-way crossover, multicenter study in patients with a documented history of EIB, with or without underlying asthma. Each patient will participate in the study for approximately 5 weeks. Each patient will complete 2 screening visits (SV1 and SV2), 2 treatment visits (TV1 and TV2), and a follow-up telephone call (FV).

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

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.

Locations and Contacts

Teva Investigational Site 10557, San Diego, California, United States

Teva Investigational Site 10555, Denver, Colorado, United States

Teva Investigational Site 10558, Denver, Colorado, United States

Teva Investigational Site 10559, Wheaton, Maryland, United States

Teva Investigational Site 10560, North Dartmouth, Massachusetts, United States

Teva Investigational Site 10556, Raleigh, North Carolina, United States

Additional Information

Starting date: March 2013
Last updated: May 21, 2015

Page last updated: August 23, 2015

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