Clinical trial NCT00665600: Efficacy and Safety of Levalbuterol in Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Double-Blind, Randomized, Multicenter, Parallel-Group Study of Levalbuterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Chronic Bronchitis
Chronic Emphysema
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-24
Enrollment: 257
Sex: ALL
Minimum age (years): 35
Maximum age (years): 99
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 repeated dosing of Levalbuterol over 6 weeks of treatment in COPD.

Detailed description: This study is a multi-center, randomized, double-blind, placebo and active controlled, parallel-group study of adult subjects with COPD. Approximately 250 subjects will be enrolled to randomize at least 200 subjects. Study participation will consist of a total of six study visits over nine weeks for each subject. 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 35 years of age at the time of consent.
* Subjects must have a pre-established primary clinical diagnosis of COPD.
* Subjects must have a baseline FEV1 less than or equal to 65%
* Subjects must have a predicted and \>0.70 Liter
* subject was taking steroids (inhaled, oral, or nasal), short-acting xanthines, or leukotrienes, the dose must have been stable for 30 days
* Subjects must have a FEV1/forced vital capacity (FVC) less than or equal to 70%
* Subjects must have a greater than or equal to 15 pack-year smoking history
* Subjects must have a baseline medical research council (MRC) dyspnea scale score greater than or equal to 2
* Regular use of a prescribed therapy for control of COPD symptoms for 3 months prior to study entry.
* No COPD exacerbations that have required an emergency room visit, hospital admission or intensive out-patient therapy within 1 month prior to study entry

Exclusion Criteria:

* Females who are pregnant or lactating.
* Concurrent requirement of oxygen therapy
* Known history of asthma, or any chronic respiratory disease other than COPD (not including chronic bronchitis or emphysema).
* Diagnosis of cancer within 5 years prior to study entry with the exception of non-melanoma skin cancer.
* Lung resection of more than one full lobe.
* Use of intravenous, intra-articular or intramuscular corticosteroids within 30 days of study entry
* History of upper or lower respiratory infection within 14 days of study entry.
* Participation in an investigational drug study within 30 days of study entry.

Primary outcomes:
measure: The primary efficacy endpoint was the time-normalized area under the percent change from visit predose in FEV1 curve (nAUC0-8 hours) averaged over the six week double-blind period.
timeFrame: Days -21, -14, 0, 14, 28, and 42
Secondary outcomes:
measure: Spirometry parameters
timeFrame: Days -21, -14, 0, 14, 28, and 42
measure: Exacerbations of COPD
timeFrame: Days -14, 0, 14, 28, 42
measure: COPD symptom ratings
timeFrame: Days 0, 14, 28, 42
measure: Baseline dyspnea and transitional dyspnea indices
timeFrame: Days 0, 14, 28, 42
measure: Ipatropium Bromide MDI use
timeFrame: Day 0, 14, 28, 42
measure: Short acting Beta-agonist MDI use
timeFrame: Days 0, 14, 28, 42
measure: Subject and physician global evaluations
timeFrame: Days 14, 28, 42
measure: St. George's Hospital Respiratory Questionnaire (SGRQ).
timeFrame: Days 0, 42
Other outcomes:
Locations:
city: Carmichael
country: United States
state: California
city: Spring Valley
country: United States
state: California
city: Wheat Ridge
country: United States
state: Colorado
city: Largo
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Panama City
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Elk Grove Village
country: United States
state: Illinois
city: Hines
country: United States
state: Illinois
city: Wheaton
country: United States
state: Maryland
city: Springfield
country: United States
state: Massachusetts
city: Cadillac
country: United States
state: Michigan
city: Columbia
country: United States
state: Missouri
city: Missoula
country: United States
state: Montana
city: Springfield
country: United States
state: New Jersey
city: Chapel Hill
country: United States
state: North Carolina
city: Mogadore
country: United States
state: Ohio
city: Providence
country: United States
state: Rhode Island
city: Austin
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Calgary
country: Canada
state: Alberta
city: Winnepeg
country: Canada
state: Manitoba
city: Mississauga
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
Study officials:
References: