- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01058863
A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 and Older With Persistent Asthma
A Double-blind, Randomized, Placebo-controlled, 5-way Crossover, Multicenter, Single-dose, Dose-ranging Study to Compare the Efficacy and Safety of Albuterol Spiromax® and ProAir® HFA in Adult and Adolescent Subjects Ages 12 and Older With Persistent Asthma
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Huntington Beach, California, United States, 92647
- Teva Clinical Study Site
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Rolling Hills Est., California, United States, 90274
- Teva Clinical Study Site
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San Diego, California, United States, 92123
- Teva Clinical Study Site
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Colorado
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Colorado Springs, Colorado, United States, 080907
- Teva Clinical Study Site
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Florida
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Margate, Florida, United States, 33036
- Teva Clinical Study Site
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Miami, Florida, United States, 33173
- Teva Clinical Study Site
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Missouri
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Saint Louis, Missouri, United States, 63141
- Teva Clinical Study Site
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New Jersey
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Skillman, New Jersey, United States, 08558
- Teva Clinical Study Site
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North Carolina
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Raleigh, North Carolina, United States, 27607
- Teva Clinical Study Site
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Ohio
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Cincinnati, Ohio, United States, 45231
- Teva Clinical Study Site
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Dayton, Ohio, United States, 45406
- Teva Clinical Study Site
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Oregon
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Medford, Oregon, United States, 97504
- Teva Clinical Study Site
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Portland, Oregon, United States, 97213
- Teva Clinical Study Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must provide written informed consent,
- Be between 12 years of age and older,
- Male or Female, females of non-child bearing potential or using reliable contraception
- Asthma for at least 6 months, FEV1 (forced expiratory volume in 1 second) between 50-80% of predicted value, and reversibility greater than or equal to 15% following 180 mcg albuterol
- Stable low dose of Inhaled Corticosteroids
- Non-smoker, 12 months smoking-free and <=10-pack years history
- Otherwise healthy
- Other criteria apply
Exclusion Criteria:
- Pregnant
- Allergic to albuterol or severe milk protein allergy
- Must not be on another trial for 30days.
- Other criteria apply
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Albuterol Spiromax® 90 mcg
A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler.
Placebo inhalers used to maintain the blind.
|
Albuterol Spiromax® delivers 90 mcg albuterol per inhalation.
Doses of 180 mcg require two inhalations.
Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.
Other Names:
Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.
|
Experimental: Albuterol Spiromax® 180 mcg
A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations).
Placebo inhalers used to maintain the blind.
|
Albuterol Spiromax® delivers 90 mcg albuterol per inhalation.
Doses of 180 mcg require two inhalations.
Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.
Other Names:
Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.
|
Active Comparator: ProAir® HFA 90 mcg
A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler.
Placebo inhalers used to maintain the blind.
|
Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.
ProAir® HFA delivers 90 mcg of albuterol per inhalation.
Doses of 180 mcg require two inhalations.
Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.
Other Names:
|
Active Comparator: ProAir® HFA 180 mcg
A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations).
Placebo inhalers used to maintain the blind.
|
Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.
ProAir® HFA delivers 90 mcg of albuterol per inhalation.
Doses of 180 mcg require two inhalations.
Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.
Other Names:
|
Placebo Comparator: Placebo Inhaler
Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler.
Placebo inhalers used to maintain the blind.
|
Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6)
Time Frame: Day 1 up to Day 30
|
FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day. The first baseline spirometry was obtained between 6-11 AM. The highest FEV1 value from two acceptable values was captured for calculation of the efficacy endpoints. Assessments were obtained at approximately 0.5 hours and immediately before dosing, and 5 minutes, 0.25, 0.50, 0.75, 1, 2, 3, 4, 5 and 6 hours after completion of dosing. |
Day 1 up to Day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline-adjusted Percent-Predicted Forced Expiratory Volume in 1 Second (PPFEV1) Area Under the Curve (AUC 0-6)
Time Frame: Day 1 up to Day 30
|
Percent-predicted FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. Percent-predicted FEV1 is the expected FEV1 taking into account age, height, gender and race, as per the National Health and Nutrition Examination Survey III (NHANES III) reference values. The first baseline spirometry was obtained between 6-11 AM. The highest FEV1 value from two acceptable values was captured for calculation of the efficacy endpoints. Assessments were obtained at approximately 0.5 hours and immediately before dosing, and 5 minutes, 0.25, 0.50, 0.75, 1, 2, 3, 4, 5 and 6 hours after completion of dosing. |
Day 1 up to Day 30
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Participants With Treatment-Emergent Adverse Events
Time Frame: Day 1 up to Day 37
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Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs).
An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug.
Relation of AE to treatment was determined by the investigator.
Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
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Day 1 up to Day 37
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Collaborators and Investigators
Investigators
- Study Director: Teva Study Leader, Teva Branded Pharmaceutical Products R&D, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Sympathomimetics
- Albuterol
- Procaterol
Other Study ID Numbers
- ABS-AS-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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