Chronic-dose Safety and Efficacy Study of a Bronchodilator Inhaler in Pediatric Asthmatics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT00308685
First received: March 28, 2006
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

This study is designed to evaluate the repeat-dose safety and effectiveness of a bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11 years with asthma. The dosing period lasts three weeks and starts following a three-week run-in period.


Condition Intervention Phase
Asthma
Drug: Albuterol 90mcg
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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Observed efficacy up to two hours following dosing [ Time Frame: Baseline to last observed ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Area under the curve (AUEC 0-6) [ Time Frame: Baseline to over six hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: July 2007
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Albuterol HFA BAI
ProAir(TM) HFA, Breath Actuated Inhalation Aerosol
Drug: Albuterol 90mcg
Placebo Comparator: Placebo HFA BAI

  Eligibility

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persistent asthma of a minimum of six months duration that has been stable for at least four weeks prior to screening
  • Male and female children aged 4-11 years, inclusive, with predicted forced expiratory volume in 1 second (FEV1) 60-90%
  • Ability to perform spirometry
  • Demonstrate 12% airways reversibility

Exclusion Criteria:

  • Require continuous treatment with beta-blockers, monoamine oxidase inhibitors, tricyclic antidepressants, anticholinergics, and/or systemic corticosteroids
  • Presence of any non-asthmatic clinically-significant acute or uncontrolled chronic diseases
  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: NCT00308685

Locations
United States, Arkansas
Little Rock Allergy and Asthma
Little Rock, Arkansas, United States, 72205-4565
United States, California
Allergy & Asthma Specialist Medical Group
Huntington Beach, California, United States, 92647
Allergy & Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States, 95117
United States, Colorado
William Storms Medical Research
Colorado Springs, Colorado, United States, 80907
Colorado Allergy and Asthma Centers, PC
Denver, Colorado, United States, 80230
Colorado Allergy and Asthma Centers, PC
Englewood, Colorado, United States, 80112
Colorado Allergy and Asthma Centers, PC
Lakewood, Colorado, United States, 80401
United States, Georgia
Southern Allergy & Asthma, PC
Savannah, Georgia, United States, 31405
United States, Illinois
Sneeze, Wheeze & Itch Associates, Inc.
Normal, Illinois, United States, 61761
United States, Minnesota
Clinical Research Institute
Minneapolis, Minnesota, United States, 55402
United States, Nebraska
The Asthma & Allergy Center, PC
Papillion, Nebraska, United States, 68046
United States, Ohio
Allergy and Respiratory Center
Canton, Ohio, United States, 44718
United States, Oklahoma
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, United States, 73120
United States, Texas
Pediatric Pulmonary Associates of North Texas
Dallas, Texas, United States, 75230
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT00308685     History of Changes
Other Study ID Numbers: IXR-303-25-167
Study First Received: March 28, 2006
Last Updated: August 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Asthma
Pediatric asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 28, 2014