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

Sponsor

Sunovion (Industry)

Overall Status

Completed

CT.gov ID

NCT00073814

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

1.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Levalbuterol tartrate MDI Drug: racemic albuterol MDI Drug: Placebo	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2002

Actual Primary Completion Date :

Jun 1, 2003

Actual Study Completion Date :

Jun 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 levalbuterol MDI 90 mcg QID	Drug: Levalbuterol tartrate MDI levalbuterol MDI 90 mcg QID Other Names: Xopenex MDI
Active Comparator: 2 racemic albuterol MDI 190 mcg QID	Drug: racemic albuterol MDI racemic albuterol MDI 180 mcg QID
Placebo Comparator: 3 Placebo MDI QID	Drug: Placebo Placebo MDI QID

Arm

Intervention/Treatment

Experimental: 1

levalbuterol MDI 90 mcg QID

Drug: Levalbuterol tartrate MDI

levalbuterol MDI 90 mcg QID

Other Names:

Xopenex MDI

Active Comparator: 2

racemic albuterol MDI 190 mcg QID

Drug: racemic albuterol MDI

racemic albuterol MDI 180 mcg QID

Placebo Comparator: 3

Placebo MDI QID

Drug: Placebo

Placebo MDI QID

Outcome Measures

Primary Outcome Measures

was peak percent change in FEV1 from visit predose averaged over the double-blind period [Week 0, 2, 4]

Secondary Outcome Measures

under the FEV1 percent change from visit predose curve averaged over the double-blind period [Week 0, 2, 4]
peak change and peak percent change in FEV1 from visit predose to each visit [Week 0, 2, 4]
peak change in FEV1 from visit predose to each visit [Week 0, 2, 4]
peak percent change in FEV1 from study baseline over the double blind period [Week 0, 2, 4]
time to peak change [Week 0, 2, 4]
peak percent of predicted FEV1 at each visit and over the double-blind period [Week 0, 2, 4]
area under the FEV1 percent change from predose curve at each visit [Week 0, 2, 4]
area under the FEV1 percent change from study baseline curve at each visit and averaged over the double-blind period [Week 0, 2, 4]
percent of predicted FEV1 AUC at each visit [Week 0, 2, 4]
percent change in predose FEV1 from study baseline at each visit [Week 0, 2, 4]
number and percent of responders [Week 0, 2, 4]
time to onset of response and duration of response [Week 0, 2, 4]

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Adolescent & Pediatric Associates, PC	Montgomery	Alabama	United States	36116
2	The Children's Clinic of Jonesboro, PA	Jonesboro	Arkansas	United States	72401
3	Integrated Research Group	Corona	California	United States	92879
4	Allergy & Asthma Specialists Medical Group	Huntington Beach	California	United States	92647
5	Asthma, Allergy & Respiratory Care Center	Long Beach	California	United States	90808
6	Madera Family Medical Group	Madera	California	United States	93637
7	Southern California Research	Mission Viejo	California	United States	92692
8	CHOC, PSF, AMC Disision of Allergy, Asthma & Immunology	Orange	California	United States	92868
9	Clinical Trials of Orange County	Orange	California	United States	92868
10	Allergy Associates Medical Group	San Diego	California	United States	92120
11	West Coast Clinical Trials, Inc.	Signal Hill	California	United States	90755
12	Allergy & Asthma Medical Group of Diablo Valley, Inc.	Walnut Creek	California	United States	94598
13	Asthma & Allergy Associates	Colorado Springs	Colorado	United States	80907
14	National Jewish Medical & Research Center	Denver	Colorado	United States	80206
15	The Allergy & Asthma Clinical Research Center	Lawrenceville	Georgia	United States	30045
16	Aeroallergy Research Laboratories of Savannah, Inc.	Savannah	Georgia	United States	31406
17	Department of Pediatric Critical Care, Kosair Children's Hospital	Louisville	Kentucky	United States	40202
18	The Pediatric Clinic	Bogalusa	Louisiana	United States	70429
19	Doctor's Care	New Orleans	Louisiana	United States	70122
20	Dolby Providers, Inc	New Orleans	Louisiana	United States	70127
21	Radiant Research	Bridgeton	Missouri	United States	63044
22	Essex-Morris Pediatric Group	Livingston	New Jersey	United States	07960
23	Princeton Center for Clinical Research	Princeton	New Jersey	United States	08540
24	Summit Pediatric Pulmonology	Summit	New Jersey	United States	07901
25	University of New Mexico, Health Sciences Center	Albuquerque	New Mexico	United States	87131
26	Pulmonary Associates of Mobile, PC	Ithaca	New York	United States	14850
27	Regional Allergy & Asthma Consultants, PA	Asheville	North Carolina	United States	28801
28	Pediatric Associates of Mt. Carmel	Cincinnati	Ohio	United States	45245
29	University Hospitals of Cleveland, Rainbow Babies & Children's Hospital	Cleveland	Ohio	United States	44106
30	Dr. Senders & Associates	University Heights	Ohio	United States	44118
31	Sooner Clinical Research	Oklahoma City	Oklahoma	United States	73112
32	Allergy & Asthma and Dermatology Research Center	Lake Oswego	Oregon	United States	97035
33	Clinical Research Institute of Southern Oregon	Medford	Oregon	United States	97504
34	Allergy Associates Research Center	Portland	Oregon	United States	97213
35	Bellevue Pediatric Association	Pittsburgh	Pennsylvania	United States	15202
36	Allergy & Asthma Consultants	Mt. Pleasant	South Carolina	United States	29464
37	Allergy, Asthma & Sinus Center, PC	Knoxville	Tennessee	United States	37922
38	Vanderbilt University ASAP Research	Nashville	Tennessee	United States	37203
39	Pediatric Allergy/Immunology Associates	Dallas	Texas	United States	75230
40	North Texas Institute for Clinical Trials	Fort Worth	Texas	United States	76132
41	Allergy & Asthma Associates	Houston	Texas	United States	77054
42	Breath of Life Research Institute	Houston	Texas	United States	77084
43	Sun Research Institute	San Antonio	Texas	United States	78205
44	PI- Coor Clinical Research, LLC	Burke	Virginia	United States	22015
45	Allergy & Asthma Associates	Kirkland	Washington	United States	98034