Safety and Tolerability Study of Levalbuterol HFA Compared to Racemic Albuterol HFA in Subjects With Asthma - Full Text View

Sponsor:	Sepracor, Inc.
Information provided by:	Sepracor, Inc.
ClinicalTrials.gov Identifier:	NCT00685022

Purpose

The purpose of this study is to compare the safety and tolerability of levalbuterol HFA metered dose inhaler (MDI) versus racemic albuterol HFA MDI.

Condition	Intervention	Phase
Asthma	Drug: Levalbuterol HFA MDI followed by Racemic albuterol HFA MDI Drug: Racemic Albuterol followed by levalbuterol HFA MDI	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study
Official Title:	A Cumulative Dose Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Subjects Twelve Years of Age and Older With 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 Sepracor, Inc.:

Primary Outcome Measures:

Increases from visit pre-dose to each post-dose dose measurement in heart rate, blood pressure (systolic and diastolic). [ Time Frame: Days 0, 7, 10 ] [ Designated as safety issue: Yes ]
Increases from visit pre-dose to each post-dose dose measurement in potassium and glucose [ Time Frame: Days 0, 7 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

FEV1 (percent change from visit pre-dose to each post dose measure) [ Time Frame: Days 0, 7, 10 ] [ Designated as safety issue: No ]
FVC (percent change from visit pre-dose to each post dose measure); [ Time Frame: Days 0, 7, 10 ] [ Designated as safety issue: No ]
FEF25-75% (percent change from visit pre-dose to each post dose measure); [ Time Frame: Days 0, 7, 10 ] [ Designated as safety issue: No ]
Number of cumulative actuations received [ Time Frame: Days 0, 7, 10 ] [ Designated as safety issue: No ]

Enrollment:	49
Study Start Date:	June 2003
Study Completion Date:	August 2003
Primary Completion Date:	August 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Subjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses). The first treatment will be administered, followed by a 7 ±2 days washout period, after which the second of the two treatments will be administered. Cumulative dosing will occur according to the following schedule: 1 puff at 0 and 30 minutes, 2 puffs at 60 minutes, 4 puffs at 90 minutes and 8 puffs at 120 minutes. All study drug will be administered directly without using a spacer for the entire study.	Drug: Levalbuterol HFA MDI followed by Racemic albuterol HFA MDI Subjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) Arm #A Xopenex HFA MDI, albuterol HFA MDI
B: Active Comparator Subjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses) The first treatment will be administered, followed by a 7 ±2 days washout period, after which the second of the two treatments will be administered. Cumulative dosing will occur according to the following schedule: 1 puff at 0 and 30 minutes, 2 puffs at 60 minutes, 4 puffs at 90 minutes and 8 puffs at 120 minutes. All study drug will be administered directly without using a spacer for the entire study.	Drug: Racemic Albuterol followed by levalbuterol HFA MDI Subjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses) Arm #B albuterol HFA MDI, Xopenex HFA MDI

Arms

Assigned Interventions

A: Experimental

Subjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses).

The first treatment will be administered, followed by a 7 ±2 days washout period, after which the second of the two treatments will be administered. Cumulative dosing will occur according to the following schedule: 1 puff at 0 and 30 minutes, 2 puffs at 60 minutes, 4 puffs at 90 minutes and 8 puffs at 120 minutes. All study drug will be administered directly without using a spacer for the entire study.

Drug: Levalbuterol HFA MDI followed by Racemic albuterol HFA MDI

Subjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses)
Arm #A
Xopenex HFA MDI, albuterol HFA MDI

B: Active Comparator

Subjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses) The first treatment will be administered, followed by a 7 ±2 days washout period, after which the second of the two treatments will be administered. Cumulative dosing will occur according to the following schedule: 1 puff at 0 and 30 minutes, 2 puffs at 60 minutes, 4 puffs at 90 minutes and 8 puffs at 120 minutes. All study drug will be administered directly without using a spacer for the entire study.

Drug: Racemic Albuterol followed by levalbuterol HFA MDI

Subjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses)
Arm #B
albuterol HFA MDI, Xopenex HFA MDI

Detailed Description:

A randomized, modified-blind active-controlled multicenter, two-way crossover study of HFA levalbuterol (without using a spacer) in subjects 12 years of age and older with asthma.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject, male or female, must be at least 12 years of age at the time of consent.
Female subjects 12-60 years of age inclusive must have a negative serum pregnancy test at study start.
Women of child bearing potential must be using an acceptable method of birth control throughout the study.
Subject must have a documented diagnosis of asthma for a minimum of 6 months prior to study start.
Subject must be in good health with the exception of their reversible airways disease and not suffering from any chronic condition that might affect their respiratory function.
Subject must have a chest X-ray or had one within 12 months prior to randomization.
Subject must be able to complete the diary cards and medical event calendars reliably on a daily basis, understand dosing instructions and be able to demonstrate good MDI administration technique. Any minor subject who is not able to do this must have a parent/legal guardian who can assist them during the study with these activities.

Exclusion Criteria:

Female subject who is pregnant or lactating.
Subject who has participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another clinical trial.
Subject whose schedule prevents him or her from starting study visits before 9 AM.
Subject who has travel commitments during the study that would interfere with trial measurements or compliance or both.
Subject who has a history of hospitalization for asthma within 4 weeks prior to study start, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial
Subject with a known sensitivity to levalbuterol or racemic albuterol, or any of the excipients contained in any of these formulations.
Subject using any prescription drug with which albuterol sulfate administration is contraindicated.
Subject with currently diagnosed life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 12 months prior to study start.
Subject with a history of cancer (exception: basal cell carcinoma in remission).
Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders.
Subject with a history of substance abuse or drug abuse within 12 months preceding study start.
Subject with greater than 10 pack year history of cigarette smoking or use of any tobacco products within 6 months of study start.
Subject with a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis.
Subject who has suffered from a clinically significant upper or lower respiratory tract infection in the 3 weeks prior to study start.
Subject with unstable asthma; or who have had a change in asthma therapy; or a visit to the Emergency Department or hospital for worsening asthma within 4 weeks.
Subject who is a staff member or relative of a staff member.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685022

Locations

United States, California

Encinitas, California, United States
United States, Massachusetts

N. Dartmouth, Massachusetts, United States
United States, Missouri

St. Louis, Missouri, United States

Sponsors and Collaborators

Sepracor, Inc.

More Information

No publications provided

Responsible Party:	Sepracor Inc. ( Xopenex Medical Director )
Study ID Numbers:	051-309
Study First Received:	May 23, 2008
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00685022 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sepracor, Inc.:

Asthma
Racemic albuterol

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Albuterol
Physiological Effects of Drugs
Reproductive Control Agents
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Tocolytic Agents

Therapeutic Uses
Immune System Diseases
Adrenergic beta-Agonists
Asthma
Anti-Asthmatic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 09, 2009