Study Stopped
IND voluntarily withdrawn, without prejudice
Controlled, 12-Week Study of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Asthmatic Patients
Randomized, Placebo-Controlled, Parallel, Multi-Center, 12-Week Study to Evaluate the Efficacy and Safety of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Adult and Adolescent Asthmatic Patients
1 other identifier
interventional
300
1 country
42
Brief Summary
This 12-week clinical study evaluates the safety and efficacy of Albuterol Sulfate HFA Inhalation Aerosol (Albuterol-HFA, or: A004), Armstrong's proposed HFA formulation of metered dose inhaler (MDI) of Albuterol (Treatment T), in comparison with:
- 1.Placebo control: (HFA propellant only, Treatment P); and
- 2.Active control: 3M/Key's Proventil-HFA (Treatment R).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 asthma
Started Sep 2007
Shorter than P25 for phase_3 asthma
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 7, 2008
CompletedFirst Posted
Study publicly available on registry
March 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedJuly 15, 2013
July 1, 2012
11 months
March 7, 2008
July 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint is the bronchodilator effect expressed as the mean area under the curve (AUC) of FEV1 (% change from Same-Day Baseline FEV1) versus time.
Concurent with each visit
Secondary Outcomes (20)
The comparative analysis of AUC of FEV1 (% change from the Same-Day Baseline) versus time, for bronchodilator effect (between Albuterol-HFA and Proventil-HFA).
End of Study
AUC of FEV1-time curve (changes of actual volumes from the Same-Day Baseline).
End of Study
Time to onset of bronchodilator effect, determined by linear interpolation as the time point where FEV1 first reaches 12% over Same-Day Baseline.
End of Study
The peak bronchodilator response, defined as the maximum FEV1 (% change from Same-Day Baseline) post-dose.
end of study
The time to peak FEV1 effect, measured as the time point of peak response, as defined (4) above.
End of Study
- +15 more secondary outcomes
Study Arms (3)
T
EXPERIMENTALalbuterol HFA 180 mcg QID
R
ACTIVE COMPARATOR180 mcg QID 12 weeks
P
PLACEBO COMPARATOR2 actuations QID 12 weeks or until use of rescue drug
Interventions
Eligibility Criteria
You may qualify if:
- Male and female asthma patients aged 12 - 75 years, in general good health.
- A documented history of mild to moderate asthma, for at-least 6-months prior to Screening, requiring inhaled B2-adrenergic agonists, with or without orally inhaled corticosteroids, for asthma treatment.
- Satisfying criteria of asthma stability, defined as no asthma-related hospitalization or emergency visits, and no significant changes in asthma therapy, over 4 weeks prior to Screening (with exception for switching from long- to short-acting B2-agonists).
- Can tolerate withholding treatment with inhaled bronchodilators and other allowed medications for the minimum washout periods indicated in Appendix II prior to the Screening Baseline FEV1 testing.
- Having a Screening Baseline FEV1 test that falls within 50-90% of the predicted values.
- Airway Reversibility PFT at screening should demonstrate a greater than 12% increase in FEV1 at 30 minutes of inhaling 2 actuations of Ventolin-HFA (180 mcg albuterol base).
- Demonstrating satisfactory techniques in the use of metered-dose inhaler (MDIs) and a hand held peak flow meter.
- Female patients of child-bearing potential being non-pregnant and non-lactating at Screening and throughout the study, and using an acceptable method of contraception during the study.
- Has properly consented to participate in this study.
You may not qualify if:
- Male and female asthma patients aged 12 - 75 years, in general good health.
- A documented history of mild to moderate asthma, for at-least 6-months prior to Screening, requiring inhaled B2-adrenergic agonists, with or without orally inhaled corticosteroids, for asthma treatment.
- Satisfying criteria of asthma stability, defined as no asthma-related hospitalization or emergency visits, and no significant changes in asthma therapy, over 4 weeks prior to Screening (with exception for switching from long- to short-acting B2-agonists).
- Can tolerate withholding treatment with inhaled bronchodilators and other allowed medications for the minimum washout periods indicated in Appendix II prior to the Screening Baseline FEV1 testing.
- Having a Screening Baseline FEV1 test that falls within 50-90% of the predicted values.
- Airway Reversibility PFT at screening should demonstrate a greater than12% increase in FEV1 at 30 minutes of inhaling 2 actuations of Ventolin-HFA (180 mcg albuterol base).
- Demonstrating satisfactory techniques in the use of metered-dose inhaler (MDIs) and a hand held peak flow meter.
- Female patients of child-bearing potential being non-pregnant and non-lactating at Screening and throughout the study, and using an acceptable method of contraception during the study.
- Has properly consented to participate in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Pulmonary Associates of Mobile, PC
Mobile, Alabama, 36608, United States
Allergy & Asthma Specialists Medical Group
Huntington Beach, California, 92647, United States
Allergy Asthma & Respiratory Care Medical Center
Long Beach, California, 90806, United States
Allergy & Asthma Care Center
Long Beach, California, 90808, United States
Southern California Research
Mission Viejo, California, 92691, United States
CHOC PSF, AMC, Divison AA and I
Orange, California, 92868, United States
Clinical Trials of Orange County
Orange, California, 92868, United States
Peninsula Research Associates
Rolling Hills Estates, California, 90274, United States
Allergy Associates Medical Group
San Diego, California, 92120, United States
Allergy & Asthma Associates of Santa Clara Valley Research Centere
San Jose, California, 95117, United States
Bensch Research Associates
Stockton, California, 95207, United States
Colorado Allergy and Asthma Centers
Denver, Colorado, 80230, United States
Colorado Allergy and Asthma Centers
Lakewood, Colorado, 80401, United States
Rocky Mountain center for Clinical Research
Wheat Ridge, Colorado, 80033, United States
Waterbury Pulmonary Research
Waterbury, Connecticut, 06708, United States
Allergy and Asthma Care of Florida
Ocala, Florida, 34471, United States
Brandon-Valrico Center for Allergy and Astham Research,LLC
Valrico, Florida, 33594, United States
Atlanta Allergy and Asthma Clinic
Woodstock, Georgia, 30188, United States
Family Allergy and Asthma Research Institute
Louisville, Kentucky, 40215, United States
Northeast Medical Research Group
North Dartmouth, Massachusetts, 02747, United States
Park Nicollet Institute
Minneapolis, Minnesota, 55416, United States
MEDEX Healthcare Research, Inc.
St Louis, Missouri, 63117, United States
The Clinical Research Center, LLC
St Louis, Missouri, 63141, United States
Clinical Research Group of Montana
Bozeman, Montana, 59718, United States
Montant Medical Research
Missoula, Montana, 59808, United States
Asthma and Allergy Center, PC
Papillion, Nebraska, 68046, United States
New Horizons Clinical Research
Cincinnati, Ohio, 45242, United States
Toledo Center for Clinical Research
Sylvania, Ohio, 43560, United States
Integrated Medical Research
Ashland, Oregon, 97520, United States
Allergy & Asthma Research Group
Eugene, Oregon, 97504, United States
Allergy Asthma and Dermatology Research
Lake Oswego, Oregon, 97035, United States
Clinical Research Institute of Southern Oregon
Medford, Oregon, 97504, United States
Allergy Associates Research Center
Portland, Oregon, 97213, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241, United States
Pharmaceutical Research & Consulting, Inc.
Dallas, Texas, 25231, United States
Allergy and Asthma Associates of Houston
Houston, Texas, 77054, United States
Clinical Trials of North Houston
Houston, Texas, 77070, United States
Kerrville Allergy and Asthma Associates
Kerrville, Texas, 78028, United States
Biogenics Research Institute
San Antonio, Texas, 78229, United States
Sylvania Research Associates
San Antonio, Texas, 78229, United States
Virginia Adult and Pediatric Allergy and Asthma, PC
Richmond, Virginia, 23229, United States
Asthma, Inc.
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2008
First Posted
March 13, 2008
Study Start
September 1, 2007
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
July 15, 2013
Record last verified: 2012-07