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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00308685
Recruitment Status : Completed
First Posted : March 30, 2006
Last Update Posted : November 26, 2015
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: Albuterol 90mcg Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2007
Actual Primary Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Albuterol HFA BAI
ProAir(TM) HFA, Breath Actuated Inhalation Aerosol
Drug: Albuterol 90mcg
Placebo Comparator: Placebo HFA BAI
Drug: Placebo

Primary Outcome Measures :
  1. Observed efficacy up to two hours following dosing [ Time Frame: Baseline to last observed ]

Secondary Outcome Measures :
  1. Area under the curve (AUEC 0-6) [ Time Frame: Baseline to over six hours post-dose ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00308685

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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.

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Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc. Identifier: NCT00308685     History of Changes
Other Study ID Numbers: IXR-303-25-167
First Posted: March 30, 2006    Key Record Dates
Last Update Posted: November 26, 2015
Last Verified: October 2015
Keywords provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ):
Pediatric asthma
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action