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Chronic-Dose Safety and Efficacy Study of an Albuterol Metered Dose Inhaler (MDI) Inhaler Using a Hydrofluoroalkane (HFA) Propellant In Pediatric Asthmatics

Information source: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Albuterol (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Teva Branded Pharmaceutical Products, R&D Inc.

Official(s) and/or principal investigator(s):
Teva Study Physician MD, Study Director, Affiliation: TEVA

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.

Clinical Details

Official title: Phase 3 Study to Evaluate the Chronic-dose Safety and Efficacy of Albuterol-HFA-MDI Relative to Placebo in Pediatric Asthmatics

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

Primary outcome:

Maximum Percent Change From Baseline

Maximum Percent Change in Peak Expiratory Flow (PEF)

Secondary outcome:

Baseline Adjusted Area-under-the-effect-curve for Percent of Predicted FEV1 Over 6 Hours Post Dose

Baseline-adjusted area-under-the Effect Curve for Percent of Predicted FEV1 Over 6 Hours Post-dose on Day 22.

Baseline-adjusted area-under-the Effect Curve for PEF Over 6 Hours Post-dose.

The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in FEVl of at Least 15% is Noted in Participants Who Responded to the Medication.

The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in PEF of at Least 15% is Noted

The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in FEVl of at Least 12% is Noted

The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in PEF of at Least 12% is Noted

The Time (in Minutes) to Maximum FEVl

The Time (in Minutes) to Maximum PEF

The Duration of Effect (in Hours) as Measured From the Time of Dosing to the Time at Which the FEVl First Decreases Below 15%

The Duration of Effect (in Hours) as Measured From the Time of Dosing the Time at Which the FEVl First Decreases Below 12%

The Duration of Effect (in Hours) as Measured From the Time of Dosing the Time at Which the PEF First Decreases Below 15%

The Duration of Effect (in Hours) as Measured From the Time of Dosing the Time at Which the PEF First Decreases Below 12%

Highest Daily Asthma Symptom Scores by Study Week

The Number of Asthma-related Nocturnal Awakenings Per Week Requiring the Use of Rescue Medication

The Daily a.m. Pre-dose PEF

The Average Number of Puffs of Rescue Medication Per 24 Hour Period

Detailed description: Eligible patients will be randomized to receive one of the following two treatments four times a day for 21 days: Placebo in a metered-dose inhaler using a hydrofluoroalkane propellant (Placebo-HFA-MDI). 180 mcg of Albuterol in a metered-dose inhaler using a hydrofluoroalkane propellant (Albuterol-HFA-MDI)

Eligibility

Minimum age: 4 Years. Maximum age: 11 Years. Gender(s): Both.

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.

Locations and Contacts

Pediatric Care Medical Group, Inc., Huntington Beach, California 92647, United States

California Allergy & Asthma Medical Group, Palmdale, California 93551, United States

Center for Clinical Trials, LLC, Paramount, California 90723, United States

Integrated Research Group, Inc, Riverside, California 92506, United States

Center for Clinical Trials of Sacramento, Sacramento, California 95823, United States

Carlos Piniella, MD, Miami, Florida 33157, United States

Sneeze, Wheeze & Itch Associates, Inc., Normal, Illinois 61761, United States

Asthma & Allergy Associates, PC, Elmira, New York 14901, United States

ENT & Allergy Associates, Newburgh, New York 12550, United States

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

Regional Allergy & Asthma Consultants, Asheville, North Carolina 28801, United States

Clinical Research Institute of Southern Oregan, PC, Medford, Oregon 97504, United States

Virginia Adult & Pediatric Allergy & Asthma, Richmond, Virginia 23229, United States

Additional Information

Starting date: August 2007
Last updated: April 11, 2012

Page last updated: August 23, 2015

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