Efficacy and Safety of Levalbuterol Versus Racemic Albuterol in Asthma - Full Text View

Sponsor:	Sunovion
Information provided by:	Sunovion
ClinicalTrials.gov Identifier:	NCT00667407

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: Levalbuterol 1.25 mg Drug: Racemic Albuterol Sulfate	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind Study to Determine the Efficacy of Levalbuterol Versus Racemic Albuterol in the Treatment of Acute Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Albuterol Levalbuterol hydrochloride Albuterol sulfate Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by Sunovion:

Primary Outcome Measures:

Time to meet discharge criteria (functional airway improvement)during the first 3 hours of Period I. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

FEV1 (Period I): Serial spirometry, maximum FEV1, time to maximum FEV1, baseline FEV1 severity on subject response; % responders, no. nebulizations to meet discharge criteria, rate of hospitalization, time to admit decision, rate for increased care [ Time Frame: Day 0 (5-10 min after every dose) ] [ Designated as safety issue: No ]
FEV1 (Period II): Spirometry, average FEV1; distribution of subject responses; rate of relapse; blinded study medication; length of stay in ED or Clinic during Period I; length of hospitalization, cost of care [ Time Frame: Days 3, 10 ] [ Designated as safety issue: No ]
Investigator and subject global evaluations, subject preference [ Time Frame: Days 3, 10 ] [ Designated as safety issue: Yes ]
Subject reported beta-mediated side effects [ Time Frame: Days 3, 10 ] [ Designated as safety issue: Yes ]

Enrollment:	627
Study Start Date:	November 2000
Study Completion Date:	August 2002
Primary Completion Date:	August 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Levalbuterol 1.25 mg	Drug: 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 Other Name: Xopenex HCl Inhalation Solution
Active Comparator: 2 Racemic Albuterol 2.5 mg	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 Other Name: Ventolin Inhalation Solution

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667407

Show 28 Study Locations

Sponsors and Collaborators

Sunovion

More Information

No publications provided

Responsible Party:	Xopenex Medical Affairs Director, Sunovion Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00667407 History of Changes
Other Study ID Numbers:	051-915
Study First Received:	April 24, 2008
Last Updated:	November 1, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sunovion:

Asthma

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs

Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012