|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Teva Branded Pharmaceutical Products, R&D Inc. |
|---|---|
| Collaborator: |
Parexel |
| Information provided by (Responsible Party): | Teva Branded Pharmaceutical Products, R&D Inc. |
| ClinicalTrials.gov Identifier: | NCT01056159 |
Purpose
The study will measure the improvement in lung function in subjects with asthma after inhaling from two inhalers, Albuterol in a dry powder inhaler and albuterol in an HFA (hydrofluoroalkane), metered dose inhaler.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Albuterol dry powder inhaler Drug: Albuterol HFA MDI (hydrofluoroalkane metered dose inhaler) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Cumulative Dose Comparison of the Efficacy and Safety of Albuterol in a Dry Powder Inhaler and an HFA MDI (Hydrofluoroalkane Metered Dose Inhaler) in Adult Patients With Asthma |
| Enrollment: | 47 |
| Study Start Date: | January 2010 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Albuterol dry powder inhaler
The participants will receive albuterol delivered with the a DPI (dry powder inhaler) and placebo with an HFA MDI inhaler (hydrofluoroalkane metered dose inhaler).
|
Drug: Albuterol dry powder inhaler
Albuterol DPI (dry powder inhaler) delivers 90mcg of albuterol in the excipient lactose with each inhalation. Albuterol will be given on two treatment days (3 to 14 days apart). On each treatment day albuterol will be given as a cumulative dose of 1440mcg as a series of inhalations using both Albuterol in a DPI (dry Powder inhaler) and albuterol in an HFA MDI (hydrofluoroalkane metered dose inhaler), ProAir. One inhaler will contain active drug and one inhaler will contain placebo.
|
|
Active Comparator: Albuterol HFA MDI
The participants will receive albuterol delivered with an HFA MDI inhaler (hydrofluoroalkane metered dose inhaler) and placebo with albuterol in a DPI (dry powder inhaler).
|
Drug: Albuterol HFA MDI (hydrofluoroalkane metered dose inhaler)
Albuterol HFA MDI (hydrofluoroalkane metered dose inhaler) delivers 90mcg of albuterol with each inhalation. Albuterol will be given on two treatment days (3to 14 days apart). On each treatment day albuterol will be given as a cumulative dose of 1440mcg as a series of inhalations using both Albuterol DPI (dry powder inhaler) and the comparator inhaler, albuterol HFA MDI (hydrofluoroalkane metered dose inhaler).One inhaler will contain active drug and one inhaler will contain placebo.
|
The study objective is to compare the efficacy and safety of albuterol in a dry powder inhaler (DPI) and albuterol in an HFA metered dose inhaler (MDI) after a cumulative dose of 1440mcg administered as 1+1+2+4+8 inhalations (90mcg per inhalation). Another study objective is to compare the pharmacokinetics (metabolism) of albuterol with the two inhalers. The pharmacokinetics of albuterol will be examined in half (24) of the study subjects. To participate in the study, patients must provide written informed consent, washout any prohibited medications and pass all the screen criteria. Once this is done, there will be two treatment visits. At each visit the subject will inhale with both types of inhalers. At each visit, one inhaler will have active drug (albuterol) and one inhaler will have placebo (dummy). The inhaler with the active drug will be switched at the two visits in a random manner. At each visit the subject will inhale with each inhaler a total of 16 times by a specific schedule. The subject will inhale from each inhaler once (1), wait 30 minutes, inhale from each inhaler once (1), wait 30 minutes, inhale from each inhaler twice (2), wait 30 minutes, inhale from each inhaler four times (4), wait 30 minutes, and then inhale from each inhaler eight times (8). The total time to complete the inhalations should be about 2 hours. Following that, there will be a series of assessments taken at regular times with vital signs measured up to 6 hours, ECG (electrocardiogram) assessed up to 4 hours, blood taken to measure potassium and glucose up to 4 hours, lung function evaluated with spirometry up to 6 hours, and for those subjects participating in the pharmacokinetic evaluation blood will be drawn up to 12 hours. The two study treatment visits will be 3 to 14 days apart. Following these visits, there will be a study concluding visit 1 to 5 days later.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Teva Clinical Study Site | |
| Los Angeles, California, United States, 90025 | |
| Teva Clinical Study Site | |
| Los Angeles, California, United States, 90048 | |
| United States, Colorado | |
| Teva Clinical Study Site | |
| Denver, Colorado, United States, 80230 | |
| Teva Clinical Study Site | |
| Lakewood, Colorado, United States, 80401 | |
| United States, Illinois | |
| Teva Clinical Study Site | |
| Normal, Illinois, United States, 61761 | |
| United States, Massachusetts | |
| Teva Clinical Study Site | |
| North Dartmouth, Massachusetts, United States, 02747 | |
| United States, Minnesota | |
| Teva Clinical Study Site | |
| Minneapolis, Minnesota, United States, 55402 | |
| United States, Nebraska | |
| Teva Clinical Study Site | |
| Bellevue, Nebraska, United States, 68123 | |
| United States, Oregon | |
| Teva Clinical Study Site | |
| Lake Oswego, Oregon, United States, 97035 | |
| Study Director: | Clinical Program Leader | Teva Branded Pharmaceutical Products, R&D Inc. |
More Information
| Responsible Party: | Teva Branded Pharmaceutical Products, R&D Inc. |
| ClinicalTrials.gov Identifier: | NCT01056159 History of Changes |
| Other Study ID Numbers: | ABS-AS-101 |
| Study First Received: | January 22, 2010 |
| Last Updated: | August 25, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
asthma dry powder inhaler short-acting beta2-agonist SABA |
bronchoconstriction bronchodilation bronchodilator metered dose inhaler |
|
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 |