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View Clinical Trial (Medical Research Study)
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A Cumulative Dose Study to Evaluate the Safety and Efficacy of Albuterol in a Dry Powder Inhaler and an HFA MDI (Hydrofluoroalkane Metered Dose Inhaler) - NCT01056159-80401 (Clinical Trial 480442)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy480442.aspx
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| City: |
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Lakewood |
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State:
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CO |
| Zip Code: |
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80401 |
| Conditions: |
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Asthma |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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Inclusion Criteria:
- Must provide written informed consent,
- Must be between 18-45 years of age,
- 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
- Otherwise healthy
- Other criteria apply
Exclusion Criteria:
- Pregnant
- Allergic to albuterol or severe milk protein allergy
- ONLY for subject participating in PK assessments, must not have donated blood within
30 days.
- Other criteria apply |
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| Study is available at: |
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Teva Clinical Study Site
Lakewood, CO 80401
United States
Primary Contact:
Clinical Study Leader
Phone: 305-575-6000 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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