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A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma

Information source: Sunovion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Levalbuterol (Drug); Levalbuterol UDV TID (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sunovion

Official(s) and/or principal investigator(s):
Respiratory Medical Director, MD, Study Director, Affiliation: Sunovion Pharmaceuticals, Inc.

Summary

A Safety, Efficacy, and Tolerability Study of Daily Dosing with Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to <48 Months with Asthma.

Clinical Details

Official title: A Safety, Efficacy, and Tolerability Study of Daily Dosing With Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to <48 Months With Asthma

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA)

Secondary outcome:

Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment

Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment

Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment

Change From Baseline to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire (PAQ)

Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by Pediatric Asthma Questionnaire

Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire

Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Score as Measured by the Pediatric Asthma Questionnaire

Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2

Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3

Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4

Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2

Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 3

Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4

Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4

Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4)

Investigator Global Assessment - Question 1

Investigator Global Assessment - Question 2

Caregiver Global Assessment - Question 1

Caregiver Global Assessment - Question 2

Caregiver Global Assessment - Question 3

Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period

Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used

Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week

Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used

Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLA) Composite Score

Detailed description: This is a modified-blind, randomized, placebo-controlled, multicenter, parallel-group trial of levalbuterol HFA MDI administered using a facemask and holding chamber in subjects birth to <48 months with asthma. 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

Minimum age: N/A. Maximum age: 48 Months. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject's parent/legal guardian must give written informed consent, including privacy

authorization, prior to study participation. Complete documentation regarding the consent process must be recorded in the case report form (CRF) and source documentation.

- Subject's parent/legal guardian must be willing and able to comply with the study

procedures and visit schedules.

- Subject, male or female, must be between the ages of birth and <48 months, exclusive,

at the time of consent.

- Subjects 24 to <48 months of age must have a history of physician-diagnosed asthma

(defined as at least 3 episodes of respiratory symptoms consistent with asthma symptoms including, but not limited to, cough, wheeze, or dyspnea).

- Subjects 0 to <24 months of age must have a history of 3 episodes of respiratory

symptoms that in the judgement of the investigator could be consistent with asthma or reactive airways disease.

- Subject must be in good health and not affected by any other chronic conditions,

including respiratory disorders other than asthma.

- In subjects with a chest radiograph (taken 12 months prior to screening visit), no

evidence of any chronic cardiopulmonary condition other than asthma should be present as discerned by the Investigator.

- Subject's parent/legal guardian must be able to complete the diary cards and medical

event calendars (MEC) reliably on a daily basis and understand dosing instructions and questionnaire completion. Exclusion Criteria:

- Subject who requires or is expected to require any disallowed medications

- Subject who has participated in an investigational drug study within 30 days prior to

screening, or who is currently participating in another clinical trial.

- Subject or parent/legal guardian who has daily commitments during the study that

would interfere with trial measurements, compliance, or both.

- Subject who has a history of hospitalization for asthma, reactive airways disease, or

bronchospasm within 4 weeks prior to screening or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial.

- Subject who has experienced significant blood loss within 60 days of study drug.

- Subject with a clinical diagnosis of cystic fibrosis.

- Subject who was born prematurely, defined as less than 38 weeks gestational age at

birth, and is <1 year of age at screening

- Subject whose body weight is less than 7. 0 kg at screening. This minimum weight

requirement is based upon standard pediatric growth charts [CDC 2000].

- 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 levalbuterol or racemic albuterol

sulfate administration is contraindicated.

- Subject with a history of life-threatening asthma, defined as previous asthma

episodes requiring intubation or associated with hypercapnia, respiratory arrest, or hypoxic seizures.

- Subject with clinically significant abnormalities that may interfere with the

metabolism or excretion of the study drugs or study participation (eg, abnormalities of renal, hepatic, metabolic, or endocrine function).

- Subject with a history of cancer.

- Subject with any chronic or congenital cardiorespiratory condition other than asthma

including, but not limited to, bronchopulmonary dysplasia, congenital heart disease, and cystic fibrosis.

- Subject affected by an upper or lower respiratory tract infection in the 3 weeks

prior to screening.

- Subject with a history of ventilation for a respiratory condition occurring at or

near birth, including those associated with prematurity or bronchopulmonary dysplasia. Ventilatory support for elective non-cardiopulmonary surgery is not

exclusionary. - Subject with any clinically significant abnormal laboratory values

(hematology, blood chemistry).

- Subject with a clinically significant abnormal 12-lead ECG that would put the subject

at risk for experiencing adverse cardiac effects.

- Subject who is a relative of a staff member.

Locations and Contacts

Little Rock Allergy & Asthma Clinical Research Center, Little Rock, Arkansas 72205, United States

West Coast Clinical Trials, LLC, Cypress, California 90630, United States

Allergy & Asthma Care Center of Southern California, Long Beach, California 90808, United States

Clinical Trials of Orange County, Inc., Orange, California 92868, United States

Allergy and Asthma Consultants, Redwood, California 94063, United States

IMMUNOe International Research Centers, Centennial, Colorado 80112, United States

All Seasons Allergy and Asthma Center, P.A., Fort Walton Beach, Florida 32547, United States

Palm Beach Research Center, West Palm Beach, Florida 33409, United States

Brookstone Centre Parkway, Columbus, Georgia 31904, United States

Rush University Medical Center, Chicago, Illinois 60612, United States

Northern Illinois Research Associates, DeKalb, Illinois 60115, United States

Sneeze, Wheeze & Itch Associates LLC, Normal, Illinois 61761, United States

Nassim, McMonigle, Mescia & Associates, New Albany, Indiana 47150, United States

Grand Blanc Medical, Grand Blanc, Michigan 48439, United States

Craig A. Spiegel MD, Bridgeton, Missouri 63044, United States

Midwest Allergy and Asthma center, Omaha, Nebraska 68130, United States

The Asthma & Allergy Center, P.C., Papillion, Nebraska 68046, United States

Maimonides Medical Center, Brooklyn, New York 11219, United States

St. Elizabeth Health Center, Utica, New York 13502, United States

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States

Dayton Clinical Research, Dayton, Ohio 45406, United States

Allergy, Asthma and clinical Research Center, Oklahoma City, Oklahoma 73120, United States

Eminence Research, LLC, Oklahoma City, Oklahoma 73139, United States

Asthma and Allergy Research Associates, Upland, Pennsylvania 19013, United States

AAC Research - PC, Charleston, South Carolina 29414, United States

National Allergy, Asthma, and Uticaria Centers, Charleston, South Carolina 29407, United States

ADAC Research, PA, Greenville, South Carolina 29607, United States

The Asthma Institute, PLLC, Chattanooga, Tennessee 37421, United States

Vanderbilt University Medical Center, Nashville, Tennessee 37203, United States

Isis Clinical Research, LLC, Austin, Texas 78731, United States

Sirius Clinical Research, LLC, Austin, Texas 78759, United States

Hill Country Family Medical Center, Boerne, Texas 78006, United States

TTS Research, Boerne, Texas 78006, United States

Allergy/Immunology Research Center of North Texas, Dallas, Texas 75230, United States

Dallas Allergy Immunology Research, Dallas, Texas 75230, United States

Western Sky Medical Research, El Paso, Texas 79903, United States

Breath of Life Research Institute, Katy, Texas 77450, United States

Live Oak Allergy and Asthma Clinic, Live Oak, Texas 78233, United States

Quality Assurance Research Center, Inc., San Antonio, Texas 78205, United States

Southwest Allergy and Asthma, P.A., San Antonio, Texas 78229, United States

Sylvana Research Associates, San Antonio, Texas 78229, United States

Allergy & Asthma Care of Waco, Waco, Texas 76712, United States

Allergy and Asthma Research Institute, Waco, Texas 76712, United States

PI-Coor Clinical Research, LLC, Burke, Virginia 22015, United States

Colonial Heights Pediatrics, Colonial Heights, Virginia 23834, United States

Bellingham Asthma, Allergy, & Immunology Clinic, Bellingham, Washington 98225, United States

Additional Information

Starting date: December 2008
Last updated: July 1, 2014

Page last updated: August 23, 2015

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