Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma

Asthma Clinical Trial

Official title:

An Efficacy, Safety, and Tolerability Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00073814
• Other study ID #: 051-354
• Status: Completed
• Phase: Phase 3
• First received: December 9, 2003
• Last updated: February 21, 2012
• Start date: December 2002
• Est. completion date: June 2003

Study information

• Verified date: February 2012
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects with Asthma

Description:

This was a Phase III, double-blind, randomized, placebo- and active-controlled, multicenter, parallel-group study of up to 6 weeks in duration. Seven days of QID single-blind, placebo administration (via HFA MDI) was followed by 28 days of QID, double-blind treatment. A follow-up visit was required only for subjects who had, in the opinion of the investigator, a clinically significant finding at Visit 6 /ET that would put the subject at risk. A final follow up phone evaluation was conducted 7 days after the completion of Visit 6/ET. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 11 Years

Eligibility

Inclusion Criteria

• Subject and subject's p/l guardian must be willing and able to comply with the study procedures and visit schedules

• Subject, male or female, between the ages of 4 to 11 yrs

• Female subjects 8 yrs or older will have a negative serum pregnancy test

• Must have a documented diagnosis of asthma for a minimum of 6 months prior to study start

• Must have stable baseline asthma and have been using a B-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 mos. prior to study start

• Must be in good health with the exception of reversible airways disease and not suffering from any chronic condition that might affect their respiratory function

• Must have a chest X-ray that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease etc

• Subject's p/l guardian must be able to complete the diary cards and medical event calendars reliably on a daily basis, understand dosing instructions and questionnaire completion, and demonstrate how to use the MiniWright PEF meter

Exclusion Criteria

• Female subject who is pregnant or lactating

• Have participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another clinical trial

• Schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9 AM

• Have travel commitments during the study that would interfere with trial measurements or compliance or both

• Have a history of hospitalization for asthma within 60 days prior to study start, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial

• Have 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

• Have currently diagnosed life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 mos. prior to study start

• Have a history of cancer

• Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders that currently are not well controlled by medication or that may interfere with the successful completion of this protocol

• Have a history of substance abuse or drug abuse within 12 months preceding V1 or a positive urine drug screening at study start

• Have a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis

• Has suffered from a clinically significant upper or lower respiratory tract infection in the 2 wks prior to study start

• Have a history of cigarette smoking or use of any tobacco products

• Subject who is a relative of a staff member

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Levalbuterol tartrate MDI
levalbuterol MDI 90 mcg QID
• racemic albuterol MDI
racemic albuterol MDI 180 mcg QID
• Placebo
Placebo MDI QID

Locations

Country	Name	City	State
United States	University of New Mexico, Health Sciences Center	Albuquerque	New Mexico
United States	Regional Allergy & Asthma Consultants, PA	Asheville	North Carolina
United States	The Pediatric Clinic	Bogalusa	Louisiana
United States	Radiant Research	Bridgeton	Missouri
United States	PI- Coor Clinical Research, LLC	Burke	Virginia
United States	Pediatric Associates of Mt. Carmel	Cincinnati	Ohio
United States	University Hospitals of Cleveland, Rainbow Babies & Children's Hospital	Cleveland	Ohio
United States	Asthma & Allergy Associates	Colorado Springs	Colorado
United States	Integrated Research Group	Corona	California
United States	Pediatric Allergy/Immunology Associates	Dallas	Texas
United States	National Jewish Medical & Research Center	Denver	Colorado
United States	North Texas Institute for Clinical Trials	Fort Worth	Texas
United States	Allergy & Asthma Associates	Houston	Texas
United States	Breath of Life Research Institute	Houston	Texas
United States	Allergy & Asthma Specialists Medical Group	Huntington Beach	California
United States	Pulmonary Associates of Mobile, PC	Ithaca	New York
United States	The Children's Clinic of Jonesboro, PA	Jonesboro	Arkansas
United States	Allergy & Asthma Associates	Kirkland	Washington
United States	Allergy, Asthma & Sinus Center, PC	Knoxville	Tennessee
United States	Allergy & Asthma and Dermatology Research Center	Lake Oswego	Oregon
United States	The Allergy & Asthma Clinical Research Center	Lawrenceville	Georgia
United States	Essex-Morris Pediatric Group	Livingston	New Jersey
United States	Asthma, Allergy & Respiratory Care Center	Long Beach	California
United States	Department of Pediatric Critical Care, Kosair Children's Hospital	Louisville	Kentucky
United States	Madera Family Medical Group	Madera	California
United States	Clinical Research Institute of Southern Oregon	Medford	Oregon
United States	Southern California Research	Mission Viejo	California
United States	Adolescent & Pediatric Associates, PC	Montgomery	Alabama
United States	Allergy & Asthma Consultants	Mt. Pleasant	South Carolina
United States	Vanderbilt University ASAP Research	Nashville	Tennessee
United States	Doctor's Care	New Orleans	Louisiana
United States	Dolby Providers, Inc	New Orleans	Louisiana
United States	Sooner Clinical Research	Oklahoma City	Oklahoma
United States	CHOC, PSF, AMC Disision of Allergy, Asthma & Immunology	Orange	California
United States	Clinical Trials of Orange County	Orange	California
United States	Bellevue Pediatric Association	Pittsburgh	Pennsylvania
United States	Allergy Associates Research Center	Portland	Oregon
United States	Princeton Center for Clinical Research	Princeton	New Jersey
United States	Sun Research Institute	San Antonio	Texas
United States	Allergy Associates Medical Group	San Diego	California
United States	Aeroallergy Research Laboratories of Savannah, Inc.	Savannah	Georgia
United States	West Coast Clinical Trials, Inc.	Signal Hill	California
United States	Summit Pediatric Pulmonology	Summit	New Jersey
United States	Dr. Senders & Associates	University Heights	Ohio
United States	Allergy & Asthma Medical Group of Diablo Valley, Inc.	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	was peak percent change in FEV1 from visit predose averaged over the double-blind period		Week 0, 2, 4	No
Secondary	under the FEV1 percent change from visit predose curve averaged over the double-blind period		Week 0, 2, 4	No
Secondary	peak change and peak percent change in FEV1 from visit predose to each visit		Week 0, 2, 4	No
Secondary	peak change in FEV1 from visit predose to each visit		Week 0, 2, 4	No
Secondary	peak percent change in FEV1 from study baseline over the double blind period		Week 0, 2, 4	No
Secondary	time to peak change		Week 0, 2, 4	No
Secondary	peak percent of predicted FEV1 at each visit and over the double-blind period		Week 0, 2, 4	No
Secondary	area under the FEV1 percent change from predose curve at each visit		Week 0, 2, 4	No
Secondary	area under the FEV1 percent change from study baseline curve at each visit and averaged over the double-blind period		Week 0, 2, 4	No
Secondary	percent of predicted FEV1 AUC at each visit		Week 0, 2, 4	No
Secondary	percent change in predose FEV1 from study baseline at each visit		Week 0, 2, 4	No
Secondary	number and percent of responders		Week 0, 2, 4	No
Secondary	time to onset of response and duration of response		Week 0, 2, 4	No