Chronic-dose Safety and Efficacy Study of a Bronchodilator Inhaler in Pediatric Asthmatics
This study has been completed.
Sponsor:
Teva Branded Pharmaceutical Products, R&D Inc.
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 16, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
MedlinePlus related topics:
Asthma
Drug Information available for:
Albuterol
Levalbuterol
Levalbuterol hydrochloride
Albuterol sulfate
Levalbuterol tartrate
U.S. FDA Resources
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
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 16, 2012 |
| 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 May 16, 2013