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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809757
• Other study ID #: 051-359
• Status: Completed
• Phase: Phase 3
• First received: December 15, 2008
• Last updated: July 1, 2014
• Start date: December 2008
• Est. completion date: June 2013

Study information

• Verified date: July 2014
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 48 Months

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Levalbuterol
90 ug Levalbuterol (2 actuations)
• Levalbuterol UDV TID
0.31 ug Levalbuterol UDV TID
• Placebo
Placebo (2 actuations)

Locations

Country	Name	City	State
United States	Isis Clinical Research, LLC	Austin	Texas
United States	Sirius Clinical Research, LLC	Austin	Texas
United States	Bellingham Asthma, Allergy, & Immunology Clinic	Bellingham	Washington
United States	Hill Country Family Medical Center	Boerne	Texas
United States	TTS Research	Boerne	Texas
United States	Craig A. Spiegel MD	Bridgeton	Missouri
United States	Maimonides Medical Center	Brooklyn	New York
United States	PI-Coor Clinical Research, LLC	Burke	Virginia
United States	IMMUNOe International Research Centers	Centennial	Colorado
United States	AAC Research - PC	Charleston	South Carolina
United States	National Allergy, Asthma, and Uticaria Centers	Charleston	South Carolina
United States	The Asthma Institute, PLLC	Chattanooga	Tennessee
United States	Rush University Medical Center	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Colonial Heights Pediatrics	Colonial Heights	Virginia
United States	Brookstone Centre Parkway	Columbus	Georgia
United States	West Coast Clinical Trials, LLC	Cypress	California
United States	Allergy/Immunology Research Center of North Texas	Dallas	Texas
United States	Dallas Allergy Immunology Research	Dallas	Texas
United States	Dayton Clinical Research	Dayton	Ohio
United States	Northern Illinois Research Associates	DeKalb	Illinois
United States	Western Sky Medical Research	El Paso	Texas
United States	All Seasons Allergy and Asthma Center, P.A.	Fort Walton Beach	Florida
United States	Grand Blanc Medical	Grand Blanc	Michigan
United States	ADAC Research, PA	Greenville	South Carolina
United States	Breath of Life Research Institute	Katy	Texas
United States	Little Rock Allergy & Asthma Clinical Research Center	Little Rock	Arkansas
United States	Live Oak Allergy and Asthma Clinic	Live Oak	Texas
United States	Allergy & Asthma Care Center of Southern California	Long Beach	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Nassim, McMonigle, Mescia & Associates	New Albany	Indiana
United States	Sneeze, Wheeze & Itch Associates LLC	Normal	Illinois
United States	Allergy, Asthma and clinical Research Center	Oklahoma City	Oklahoma
United States	Eminence Research, LLC	Oklahoma City	Oklahoma
United States	Midwest Allergy and Asthma center	Omaha	Nebraska
United States	Clinical Trials of Orange County, Inc.	Orange	California
United States	The Asthma & Allergy Center, P.C.	Papillion	Nebraska
United States	Allergy and Asthma Consultants	Redwood	California
United States	Quality Assurance Research Center, Inc.	San Antonio	Texas
United States	Southwest Allergy and Asthma, P.A.	San Antonio	Texas
United States	Sylvana Research Associates	San Antonio	Texas
United States	Asthma and Allergy Research Associates	Upland	Pennsylvania
United States	St. Elizabeth Health Center	Utica	New York
United States	Allergy & Asthma Care of Waco	Waco	Texas
United States	Allergy and Asthma Research Institute	Waco	Texas
United States	Palm Beach Research Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA)	The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).; The mean daily composite score at Visit 4 is defined as the mean of the daily composite scores in the week prior to Visit 4.	Baseline, Visit 4 (Week 4)	No
Secondary	Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment	The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).; The mean daily composite score at Visit 3 is defined as the mean of the daily composite scores in the 7 days prior to Visit 3.	Baseline, Visit 3 (Week 3)	No
Secondary	Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment	The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).; The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3.	The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days	No
Secondary	Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment	The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).; The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4.	The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days	No
Secondary	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)	The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).; The mean daily composite score at Visit 3 is defined as the mean daily composite scores for 7 days prior to Visit 3.	Baseline, Visit 3 (Week 3)	No
Secondary	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	The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).; The mean daily composite score at Visit 4 is defined as the mean daily composite scores in the 7 days prior to Visit 4.	Baseline, Visit 4 (Week 4)	No
Secondary	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	The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).; The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3.	The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days	No
Secondary	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	The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).; The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4.	The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days	No
Secondary	Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2	Peak expiratory flow (PEF) measures how fast a person can breathe out using the greatest effort	Baseline, Visit 2: 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose	No
Secondary	Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3		Baseline, Visit 3, pre-dose (approximately 14 days after randomization)	No
Secondary	Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4		Visit 4: pre-dose (approximately 28 days after randomization) , 30 minutes post-dose, 1 hour post-dose, 4 hours post-dose, 6 hours post-dose	No
Secondary	Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2		Baseline, Visit 2: , 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose	No
Secondary	Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 3		Baseline, Visit 3, pre -dose (approximately 14 days after randomization)	No
Secondary	Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4		Baseline, Visit 4, pre -dose (approximately 28 days after randomization)	No
Secondary	Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4	Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to <48 months capable of performing acceptable and reproducible PEF maneuvers.	Baseline, Visit 3 (the week prior to Visit 3) and Visit 4	No
Secondary	Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4)	Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to <48 months capable of performing acceptable and reproducible PEF maneuvers.	Visit 3 (the week prior to Visit 3), Visit 4 (the week prior to Visit 4)	No
Secondary	Investigator Global Assessment - Question 1	Since the start of the study, how would you evaluate the child's asthma symptoms?	Visit 4 (End of 28 day treatment period)	No
Secondary	Investigator Global Assessment - Question 2	Since the start of the study, how would you evaluate your ability to manage the subject's asthma?	Visit 4 (End of 28 day treatment period)	No
Secondary	Caregiver Global Assessment - Question 1	Since the start of the study, how would you evaluate your child's asthma symptoms?	Visit 4 (End of 28 day treatment period)	No
Secondary	Caregiver Global Assessment - Question 2	Since the start of the study, how would you evaluate your ability to manage your child's asthma?	Visit 4 (End of 28 day treatment period)	No
Secondary	Caregiver Global Assessment - Question 3	Overall I was: Very satisfied with the control of the child's asthma symptoms while enrolled in this study, Moderately satisfied with the control of the child's asthma symptoms while enrolled in this study, Slightly satisfied with the control of the child's asthma symptoms while enrolled in this study, Not satisfied with the control of the child's asthma symptoms while enrolled in this study or answer Missing	Visit 4 (End of 28 day treatment period)	No
Secondary	Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period	Number of subjects using rescue medication during the treatment period	Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)	No
Secondary	Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used		Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)	No
Secondary	Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week		Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)	No
Secondary	Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used		Visit 2 to Visit 3 (the first 2 weeks of the study), Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)	No
Secondary	Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLA) Composite Score	The PACQLQ composite score was calculated as the mean of the scores of the 13 individual questions. Composite scores could range from 1 to 7. Lower scores indicated greater impact of disease on quality of life.	Visit 3 and Visit 4 (End of 28 day treatment period)	No