A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 and Older With Persistent Asthma
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:
NCT01058863
First received: January 27, 2010
Last updated: October 17, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
This study is examining how well a dry powder inhaler (DPI) of albuterol medication works to help adult and adolescent subjects 12 years of age and older with persistent asthma to improve lung function. During the trial the participants will also be given a hydrofluoroalkane (HFA) , metered dose inhaler (MDI) of albuterol. These medications will be given to the participants at two different doses. Approximately 66 participants will be enrolled in the study following screening and a 14 day run-in period. Participants who qualify for the study will be selected randomly to receive all of the treatments, on separate occasions, including placebo on one of the treatment days, 3-7 days apart. There will be 5 visits where the medications are given. The total number of clinic visits are approximately 7 visits to the clinic.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Albuterol DPI 90mcg Drug: Albuterol MDI 90mcg Drug: Albuterol DPI 180mcg Drug: Albuterol MDI 180mcg Other: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Double-blind, Randomized, Placebo-controlled, 5-way Crossover, Multicenter, 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 |
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:
- Primary Efficacy Endpoint: Baseline-adjusted forced expiratory volume at one second (FEV1) liters per hour (L*hr) area-under-the-curve (AUC0-6). Tthe baseline is the treatment day baseline. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Baseline-adjusted percent predicted FEV1percent per hour (%*hr) AUC0-6 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Spontaneous and elicited treatment emergent adverse events (AEs);physical exam; vital signs. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 72 |
| Study Start Date: | February 2010 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Albuterol DPI 90mcg
Albuterol 90mcg delivered with a DPI inhaler
|
Drug: Albuterol DPI 90mcg
Albuterol DPI delivers 90mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Drug: Albuterol MDI 90mcg
Albuterol MDI delivers 90mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Other: Placebo
Three inhalers will contain placebo given as double-blind medication on one of 5 treatment days.
|
|
Experimental: Albuterol DPI 180mcg
Albuterol 180 mcg delivered with a DPI inhaler
|
Drug: Albuterol DPI 180mcg
Albuterol DPI delivers 180mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Drug: Albuterol MDI 180mcg
Albuterol MDI delivers 180mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Other: Placebo
Three inhalers will contain placebo given as double-blind medication on one of 5 treatment days.
|
|
Active Comparator: Albuterol MDI 90mcg
Albuterol 90 mcg delivered with a MDI inhaler
|
Drug: Albuterol DPI 90mcg
Albuterol DPI delivers 90mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Drug: Albuterol MDI 90mcg
Albuterol MDI delivers 90mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Other: Placebo
Three inhalers will contain placebo given as double-blind medication on one of 5 treatment days.
|
|
Active Comparator: Albuterol MDI 180mcg
Albuterol 180 mcg delivered with a MDI inhaler
|
Drug: Albuterol DPI 180mcg
Albuterol DPI delivers 180mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Drug: Albuterol MDI 180mcg
Albuterol MDI delivers 180mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Other: Placebo
Three inhalers will contain placebo given as double-blind medication on one of 5 treatment days.
|
|
Placebo Comparator: Placebo
Placebo given as double-blind medication
|
Drug: Albuterol DPI 90mcg
Albuterol DPI delivers 90mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Drug: Albuterol MDI 90mcg
Albuterol MDI delivers 90mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Drug: Albuterol DPI 180mcg
Albuterol DPI delivers 180mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Drug: Albuterol MDI 180mcg
Albuterol MDI delivers 180mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 180mcg albuterol
- Stable low dose of Inhaled Corticosteroids
- Non-smoker, 12 month 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058863
Locations
| United States, California | |
| Teva Clinical Study Site | |
| Huntington Beach, California, United States, 92647 | |
| Teva Clinical Study Site | |
| Rolling Hills Est., California, United States, 90274 | |
| Teva Clinical Study Site | |
| San Diego, California, United States, 92123 | |
| United States, Colorado | |
| Teva Clinical Study Site | |
| Colorado Springs, Colorado, United States, 080907 | |
| United States, Florida | |
| Teva Clinical Study Site | |
| Margate, Florida, United States, 33036 | |
| Teva Clinical Study Site | |
| Miami, Florida, United States, 33173 | |
| United States, Missouri | |
| Teva Clinical Study Site | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New Jersey | |
| Teva Clinical Study Site | |
| Skillman, New Jersey, United States, 08558 | |
| United States, North Carolina | |
| Teva Clinical Study Site | |
| Raleigh, North Carolina, United States, 27607 | |
| United States, Ohio | |
| Teva Clinical Study Site | |
| Cincinnati, Ohio, United States, 45231 | |
| Teva Clinical Study Site | |
| Dayton, Ohio, United States, 45406 | |
| United States, Oregon | |
| Teva Clinical Study Site | |
| Medford, Oregon, United States, 97504 | |
| Teva Clinical Study Site | |
| Portland, Oregon, United States, 97213 | |
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
| Study Director: | Teva Study Leader | 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: | NCT01058863 History of Changes |
| Other Study ID Numbers: | ABS-AS-201 |
| Study First Received: | January 27, 2010 |
| Last Updated: | October 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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 23, 2013