Clinical trial NCT00667407: Efficacy and Safety of Levalbuterol Versus Racemic Albuterol in Asthma
Official title: A Randomized, Double-Blind Study to Determine the Efficacy of Levalbuterol Versus Racemic Albuterol in the Treatment of Acute Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-28
Enrollment: 627
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Time to meet discharge criteria (functional airway improvement)during the first 3 hours of Period I.
timeFrame: 24 hours
Secondary outcomes:
measure: 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
timeFrame: Day 0 (5-10 min after every dose)
measure: 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
timeFrame: Days 3, 10
measure: Investigator and subject global evaluations, subject preference
timeFrame: Days 3, 10
measure: Subject reported beta-mediated side effects
timeFrame: Days 3, 10
Other outcomes:
Locations:
city: Hoover
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Encinitas
country: United States
state: California
city: Fresno
country: United States
state: California
city: Oakland
country: United States
state: California
city: Torrance
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Metairie
country: United States
state: Louisiana
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Red Bank
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: New Hyde Park
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Rocky Mount
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Lake Oswego
country: United States
state: Oregon
city: Medford
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
Study officials:
References: