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Sponsored by: |
Amphastar Pharmaceuitcals, Inc. |
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Information provided by: | Amphastar Pharmaceuitcals, Inc. |
ClinicalTrials.gov Identifier: | NCT00635505 |
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:
The treatments will be given as self-administered oral inhalations in adult and adolescent patients with mild-to-moderate asthma, for 12-weeks. Dosing regimen throughout the 12-week study is two actuations four times daily (QID).
Condition | Intervention | Phase |
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Asthma |
Drug: albuterol HFA (Armstrong's) Drug: albuterol HFA (Proventil HFA) Drug: HFA placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 300 |
Study Start Date: | September 2007 |
Study Completion Date: | June 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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T: Experimental
albuterol HFA 180 mcg QID
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Drug: albuterol HFA (Armstrong's)
180 mcg QID 12 weeks
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R: Active Comparator
180 mcg QID 12 weeks
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Drug: albuterol HFA (Proventil HFA)
180 mcg QID 12 weeks
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P: Placebo Comparator
2 actuations QID 12 weeks or until use of rescue drug
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Drug: HFA placebo
2 actuations QID 12 weeks or until use of rescue drug
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This is a randomized, parallel, multicenter, 12-week study in adolescent and adult patients with mild-to-moderate asthma, to evaluate the efficacy and safety of Armstrong's Albuterol-HFA MDI, in comparison to a Placebo Control and an Active Control of Proventil-HFA. While Albuterol-HFA (Treatment T) and Placebo (Treatment P) will be double-blinded to both the subjects and investigational staff, the active comparator drug, Proventil-HFA (Treatment R), can only be evaluator-blinded, due to: (1) its physical appearance differing from that of the T and P devices; and (2) unavailability of a Proventil-HFA placebo which would otherwise be used for a double-dummy design. All study medications will have the canisters and all product-identifying text or graphics (e.g., molded text on actuator) masked so that the treatments cannot be identified. No subject in any study arm will be given any information that could reveal the nature of the treatment given. All study subjects will be instructed not to reveal or discuss the study medications to the study staff or other subjects. The designated study evaluator(s), who conduct the clinical visits and safety and efficacy evaluations and perform the data recording and transcription, will be blinded to the study medications.
All subjects will be screened for enrollment, and will be randomized into the following three treatment groups in a double-blinded (for Treatments T and P) or evaluator-blinded (for Treatment R) manner:
Treatment T (Albuterol-HFA, N=200): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), QID; Treatment R (Proventil-HFA, N=50): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), QID; Treatment P (Placebo-HFA, N=50): two actuations of placebo, QID.
Randomization is achieved with blocks of six (6), with four (4) patients receiving Albuterol-HFA for every one
(1) patient receiving Proventil-HFA and every one (1) receiving the Placebo-HFA. At each Clinical Visit that takes place every 3 weeks, the double-blinded (T, P) or evaluator-blinded (R) study drugs will be distributed in resealable masking pouches to the subjects of each arm.
An additional aim of the study is to evaluate the effect of weekly cleaning on the Albuterol-HFA MDI device clinical performance throughout the four, 3-week life-of-device treatment cycles, in conformance with the FDA's specific requirements.
Arms:
All subjects will be screened for enrollment, and will be randomized into the following three treatment groups in a double-blinded (for Treatments T and P) or evaluator-blinded (for Treatment R) manner:
Treatment T (Albuterol-HFA, N=200): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), QID; Treatment R (Proventil-HFA, N=50): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), QID; Treatment P (Placebo-HFA, N=50): two actuations of placebo, QID.
Ages Eligible for Study: | 12 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Amphastar Pharmaceuticals, Inc. ( Stephen Campbell, Senior Vice President, Regulatory Affairs ) |
Study ID Numbers: | API-A004-CLN-C |
Study First Received: | March 7, 2008 |
Last Updated: | July 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00635505 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Asthma albuterol HFA |
Neurotransmitter Agents Adrenergic beta-Agonists Bronchial Diseases Adrenergic Agents Albuterol Asthma Anti-Asthmatic Agents Adrenergic Agonists |
Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Albuterol Physiological Effects of Drugs Reproductive Control Agents Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Tocolytic Agents |
Therapeutic Uses Immune System Diseases Adrenergic beta-Agonists Asthma Anti-Asthmatic Agents Pharmacologic Actions Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |