Efficacy and Safety of Levalbuterol Versus Racemic Albuterol in Asthma

NCT ID: NCT00667407

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 627 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-11-30
• Study Completion Date: 2002-08-31

Brief Summary

To investigate the Efficacy and Safety of Levalbuterol versus Racemic Albuterol in the Treatment of Acute Asthma.

Detailed Description

This study is a double-blind, randomized, active-controlled, multicenter, parallel-group trial of levalbuterol in adult subjects with acute reversible airways disease. Approximately 600 subjects will be enrolled and study participation will consist of 2 periods: Period I (Acute Period): Double-blind treatment in the Emergency Department (ED) or Clinic until disposition, for a maximum of 24 hours of double-blind treatment and Period II (Post-Acute Period): Subjects discharged from the ED or Clinic will continue double blind treatment (with the same treatment provided as rescue medication as MDI) for approximately 10 days. Subjects will be contacted by telephone 30 days post discharge to assess relapse. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Levalbuterol 1.25 mg

Group Type: EXPERIMENTAL

Levalbuterol 1.25 mg

Intervention Type: DRUG

levalbuterol 1.25 mg Period I: administered every 20 minutes for the first 3 doses, and then every 40 minutes for the next 3 doses; then as clinically indicated.

Period II: TID for 3 days (same time of day), then PRN to TID for 7 days

2

Racemic Albuterol 2.5 mg

Group Type: ACTIVE_COMPARATOR

Racemic Albuterol Sulfate

Intervention Type: DRUG

Racemic Albuterol 2.5 mg Period I: every 20 min for the first 3 doses, then every 40 min for the next 3 doses, then as clinically indicated.

Period II: TID for 3 days then PRN to TID for 7 days

Interventions

Levalbuterol 1.25 mg

levalbuterol 1.25 mg Period I: administered every 20 minutes for the first 3 doses, and then every 40 minutes for the next 3 doses; then as clinically indicated.

Period II: TID for 3 days (same time of day), then PRN to TID for 7 days

Intervention Type: DRUG

Racemic Albuterol Sulfate

Racemic Albuterol 2.5 mg Period I: every 20 min for the first 3 doses, then every 40 min for the next 3 doses, then as clinically indicated.

Period II: TID for 3 days then PRN to TID for 7 days

Intervention Type: DRUG

Other Intervention Names

Xopenex HCl Inhalation Solution; Ventolin Inhalation Solution

Eligibility Criteria

Inclusion Criteria

• Male and female subjects must be at least greater than or equal to 18 years of age at the time of consent.
• Subjects must have history of asthma for at least 6 months.
• Subjects must present to the emergency department (ED) or clinic with forced expiratory volume in one second (FEV1) of 20 to 55% (inclusive) predicted at baseline
• Subjects must have O2 saturation greater than or equal to 90% at room air or with no more than 6 Liters/minute supplemental oxygen and no other cause of wheezing or shortness of breath other than asthma as determined by the physician.
• Prior use of a beta-agonist (e.g., Primatine Mist, albuterol, salmeterol, etc.) within 24 hours of presentation to the ED or Clinic.
• Smoked ≤ 10 pack-years or non-smoker.
• Be in good health with the exception of asthma and not suffering from any chronic condition which might affect their lung function, such as COPD or emphysema.
• Near-normal activity level between exacerbations.
• Subjects who are taking inhaled or systemic corticosteroids must be on a stable dose for at least 21 days prior to study entry.

Exclusion Criteria

• Subjects who have received treatment for asthma in an ED, Clinic, or Urgent Care Center within 2 weeks prior to study entry.
• Based upon history or physical exam in the ED or Clinic, subjects with known or suspected cause of pulmonary symptoms other than asthma, such as COPD, CHF, pneumonia, pulmonary embolism, or angioedema.
• Subjects with a history of asthma episodes associated with hypercapnia, respiratory arrest, hypoxic seizures, or requiring intubation within 12 months prior to entry.
• Hospitalization for asthma within two months prior to entry.
• Female subjects who are pregnant or lactating.
• Subjects who have a history of a clinically significant psychiatric disorder within the last 3 months, with the exception of mild depression.
• Subjects who have participated in an investigational drug study within 30 days of study entry or have previously participated in the current trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hoover, Alabama, United States

Montgomery, Alabama, United States

Encinitas, California, United States

Fresno, California, United States

Oakland, California, United States

Torrance, California, United States

Colorado Springs, Colorado, United States

Gainesville, Florida, United States

Jacksonville, Florida, United States

Tampa, Florida, United States

Chicago, Illinois, United States

Metairie, Louisiana, United States

Ann Arbor, Michigan, United States

Detroit, Michigan, United States

Kansas City, Missouri, United States

St Louis, Missouri, United States

Red Bank, New Jersey, United States

Brooklyn, New York, United States

New Hyde Park, New York, United States

Syracuse, New York, United States

Rocky Mount, North Carolina, United States

Akron, Ohio, United States

Cleveland, Ohio, United States

Lake Oswego, Oregon, United States

Medford, Oregon, United States

Philadelphia, Pennsylvania, United States

Houston, Texas, United States

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

051-915

Identifier Type: -

Identifier Source: org_study_id