Clinical trial NCT00577655: Albuterol HFA MDI in Pediatric Participants With Asthma
Official title: Phase 3 Study to Evaluate the Chronic-dose Safety and Efficacy of Albuterol-HFA-MDI Relative to Placebo in Pediatric Asthmatics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Pediatric, asthma, albuterol-HFA and Placebo
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2007-12-20
Enrollment: 103
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the chronic-dose and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.


Eligibility criteria: Inclusion Criteria:

* Male and female child aged 4-11 years, inclusive Asthma of a minimum of six months duration that has been stable for at least four weeks prior to screening.

Exclusion Criteria:

* Hospitalization for acute asthma exacerbation greater than two years in 12 months prior to screening and/or received ER treatment or hospitalization for asthma exacerbation.

Primary outcomes:
measure: Maximum Percent Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Observed up to Two Hours Post Dose (FEV1max%0-2) on Day 22
timeFrame: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing on Day 22 or last observation
measure: Maximum Percent Change From Baseline in Peak Expiratory Flow (PEF) Observed up to Two Hours Post Dose (PEFmax%0-2) on Day 22
timeFrame: 30±5 and 5±2 minutes prior to dosing, and at 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing on Day 22 or last observation
Secondary outcomes:
measure: Maximum Percent Change From Baseline in Forced Expiratory Volume in One Second (FEV1) up to Two Hours Post-Dose (FEV1max%0-2, %) on Study Days 1 and 22 Using Observed Cases
timeFrame: Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing
measure: Maximum Percent Change From Baseline in Peak Expiratory Flow (PEF) up to Two Hours Post-Dose (PEFmax%0-2) on Study Days 1 and 22 Using Observed Cases
timeFrame: Days 1 and 22: 30±5 and 5±2 minutes prior to dosing, and 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing
measure: Baseline Adjusted Area-under-the-Effect Curve for Percent of Predicted Forced Expiratory Volume in One Second (FEV1) Over 6 Hours Post-dose on Day 22 Using Both Day 1 and Day 22 Baselines
timeFrame: Baseline (Day 1 or Day 22: 35±5 and 10±2 minutes prior to dosing), Day 22 (5±2, 15±5, 30±5, 45±5, 60±10, 120±10, 240±10, and 360±10 minutes post-dosing or last observation)
measure: Baseline-Adjusted Area-under-the Effect Curve for Peak Expiratory Flow (PEF) Over 6 Hours Post-dose on Day 22 Using Both Day 1 and Day 22 Baselines
timeFrame: Baseline (Day 1 or Day 22: 30±5 and 5±2 minutes prior to dosing Day 22: 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing or last observation
measure: Maximum Percent-Predicted FEV1 (Max PPFEV1, %) Observed up to Two Hours Following Completion of Dosing on Study Days 1 and 22 (Observed Case)
timeFrame: Days 1 and 22: 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing
measure: Time To Maximum Forced Expiratory Volume in One Second (FEV1) Over Six Hours Post-Dose On Days 1 and 22
timeFrame: Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing
measure: Time To Maximum Peak Expiratory Flow (PEF) Over Six Hours Post-Dose On Days 1 and 22
timeFrame: Days 1 and 22: 30±5 and 5±2 minutes prior to dosing, and 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing
measure: Participant Responses: Percentage of Participants With a >=15% Increase in Baseline FEV1 Within 30 Minutes Post-Dose on Days 1 and 22
timeFrame: Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing
measure: Participant Responses: Percentage of Participants With a >=12% Increase in Baseline FEV1 Within 30 Minutes Post-Dose on Days 1 and 22
timeFrame: Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing
measure: Participant Responses: Percentage of Participants With a >=15% Increase in Baseline PEF Within 30 Minutes Post-Dose on Days 1 and 22
timeFrame: Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing
measure: Participant Responses: Percentage of Participants With a >=12% Increase in Baseline PEF Within 30 Minutes Post-Dose on Days 1 and 22
timeFrame: Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing
measure: Weekly Average Highest (Worst) Daily Asthma Symptom Scores for Weeks 1, 2 and 3
timeFrame: Weeks 1, 2, 3
measure: The Number of Asthma-Related Nocturnal Awakenings Per Week Requiring the Use of Rescue Medication
timeFrame: Run-in (Days -21 to -1), Weeks 1, 2, 3
measure: Weekly Average Peak Expiratory Flow (PEF) Obtained Pre-Dose Each Morning
timeFrame: Weeks 1, 2, 3
measure: Weekly Average Number of Puffs of Rescue Medication Taken Each Day for Study Weeks 1, 2 and 3
timeFrame: Weeks 1, 2, 3
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Pediatric Care Medical Group, Inc.
state: California
city: Palmdale
country: United States
facility: California Allergy & Asthma Medical Group
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: Riverside
country: United States
facility: Integrated Research Group, Inc
state: California
city: Sacramento
country: United States
facility: Center for Clinical Trials of Sacramento
state: California
city: Miami
country: United States
facility: Carlos Piniella, MD
state: Florida
city: Normal
country: United States
facility: Sneeze, Wheeze & Itch Associates, Inc.
state: Illinois
city: Elmira
country: United States
facility: Asthma & Allergy Associates, PC
state: New York
city: Newburgh
country: United States
facility: ENT & Allergy Associates
state: New York
city: Utica
country: United States
facility: St. Elizabeth's Children Health Center
state: New York
city: Asheville
country: United States
facility: Regional Allergy & Asthma Consultants
state: North Carolina
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregan, PC
state: Oregon
city: Richmond
country: United States
facility: Virginia Adult & Pediatric Allergy & Asthma
state: Virginia
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Study Physician MD
role: STUDY_DIRECTOR
References: