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

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Exercise-Induced Bronchoconstriction (EIB)

Treatments: Drug: Placebo Spiromax; Drug: Albuterol Spiromax

Study type: Interventional

Funder types: Industry

Identifiers

NCT01791972

ABS-AS-302

Details and patient eligibility

About

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.

Full 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).

Enrollment: 38 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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38 participants in 2 patient groups

Albuterol Spiromax / Placebo Spiromax

Experimental group

Description:

Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on Day 1. Placebo Spiromax (2 inhalations), single dose on approximately Day 7.

Treatment:

Drug: Albuterol Spiromax

Drug: Placebo Spiromax

Placebo Spiromax / Albuterol Spiromax

Experimental group

Description:

Placebo Spiromax, (2 inhalations), single dose on Day 1. Albuterol Spiromax 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on approximately Day 7.

Treatment:

Drug: Albuterol Spiromax

Drug: Placebo Spiromax