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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier:
NCT00577655
First received: December 18, 2007
Last updated: April 11, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Asthma
Drug: Albuterol
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Study to Evaluate the Chronic-dose Safety and Efficacy of Albuterol-HFA-MDI Relative to Placebo in Pediatric Asthmatics

Resource links provided by NLM:


Further study details as provided by Teva Branded Pharmaceutical Products, R&D Inc.:

Primary Outcome Measures:
  • Maximum Percent Change From Baseline [ Time Frame: 2 hours following completion of dosing on Day 22 ] [ Designated as safety issue: No ]
    The FEV1 test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the amount of air blown over time. The maximum percent change from baseline in the Forced Expiratory Volume in one second (FEV1) observed up to 2 hours following completion of dosing using Day 22 baseline.

  • Maximum Percent Change in Peak Expiratory Flow (PEF) [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
    The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the amount of air blown over time. Maximum percent change in Peak Expiratory Flow (PEF) observed up to 2 hours following completion of dosing using Day 22 baseline.


Secondary Outcome Measures:
  • Baseline Adjusted Area-under-the-effect-curve for Percent of Predicted FEV1 Over 6 Hours Post Dose [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Baseline

  • Baseline-adjusted area-under-the Effect Curve for Percent of Predicted FEV1 Over 6 Hours Post-dose on Day 22. [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • Baseline-adjusted area-under-the Effect Curve for PEF Over 6 Hours Post-dose. [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in PEF of at Least 15% is Noted [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in FEVl of at Least 12% is Noted [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in PEF of at Least 12% is Noted [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • The Time (in Minutes) to Maximum FEVl [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • The Time (in Minutes) to Maximum PEF [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • The Duration of Effect (in Hours) as Measured From the Time of Dosing to the Time at Which the FEVl First Decreases Below 15% [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • The Duration of Effect (in Hours) as Measured From the Time of Dosing the Time at Which the FEVl First Decreases Below 12% [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • The Duration of Effect (in Hours) as Measured From the Time of Dosing the Time at Which the PEF First Decreases Below 15% [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • The Duration of Effect (in Hours) as Measured From the Time of Dosing the Time at Which the PEF First Decreases Below 12% [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • Highest Daily Asthma Symptom Scores by Study Week [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    Highest daily asthma symptom scores by study week. For this assessment, patients self-evaluate and record on the diary card the following asthma symptoms experienced during the day (i.e. last 12-14 hours): wheeze, shortness of breath, cough, tightness of chest. The worst of these symptoms will be scored daily as 0 = No symptoms occurred, 1 = Symptom occurred but did not interfere with daily activity, 2 = Symptom occurred but was sometimes annoying or interfered with daily activity, 3 = Symptom present even at rest and was annoying or interfered with daily activity

  • The Number of Asthma-related Nocturnal Awakenings Per Week Requiring the Use of Rescue Medication [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
  • The Daily a.m. Pre-dose PEF [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
  • The Average Number of Puffs of Rescue Medication Per 24 Hour Period [ Time Frame: Week 3 ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: August 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 180 mcg of Albuterol
Dosing with 180 mcg of albuterol in a metered-dose inhaler (MDI) utilizing a hydrofluoroalkane (HFA) propellant. (Hereafter noted as "Albuterol HFA-MDI.")
Drug: Albuterol
Albuterol HFA MDI 180 mcg
Placebo Comparator: Placebo
A placebo of a metered-dose inhaler (MDI) utilizing a hydrofluoroalkane (HFA) propellant. (Hereafter noted as "Placebo-HFA-MDI.")
Drug: Placebo
Placebo HFA MDI

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

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577655

Locations
United States, California
Pediatric Care Medical Group, Inc.
Huntington Beach, California, United States, 92647
California Allergy & Asthma Medical Group
Palmdale, California, United States, 93551
Center for Clinical Trials, LLC
Paramount, California, United States, 90723
Integrated Research Group, Inc
Riverside, California, United States, 92506
Center for Clinical Trials of Sacramento
Sacramento, California, United States, 95823
United States, Florida
Carlos Piniella, MD
Miami, Florida, United States, 33157
United States, Illinois
Sneeze, Wheeze & Itch Associates, Inc.
Normal, Illinois, United States, 61761
United States, New York
Asthma & Allergy Associates, PC
Elmira, New York, United States, 14901
ENT & Allergy Associates
Newburgh, New York, United States, 12550
St. Elizabeth's Children Health Center
Utica, New York, United States, 13502
United States, North Carolina
Regional Allergy & Asthma Consultants
Asheville, North Carolina, United States, 28801
United States, Oregon
Clinical Research Institute of Southern Oregan, PC
Medford, Oregon, United States, 97504
United States, Virginia
Virginia Adult & Pediatric Allergy & Asthma
Richmond, Virginia, United States, 23229
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Director: Teva Study Physician MD TEVA
  More Information

No publications provided

Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT00577655     History of Changes
Other Study ID Numbers: IXR-302-25-105
Study First Received: December 18, 2007
Results First Received: July 21, 2009
Last Updated: April 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Branded Pharmaceutical Products, R&D Inc.:
Pediatric, asthma, albuterol-HFA and Placebo

Additional relevant MeSH terms:
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014