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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00554970 |
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Date of registration:
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30/10/2007 |
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Primary sponsor: |
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Public title:
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A Study of 2 Doses of MAP0010 in Adult Asthmatics
P202 |
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Scientific title:
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A Randomized, Open Label, Active-Controlled, 4-Treatment, 2-Period, 2 Parallel Block Crossover Pharmacokinetic and Safety Study of 2 Doses of MAP0010 in Adult Asthmatics |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00554970 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female adult asthmatics with mild to moderate persistent asthma.
- 18 to 45 (up to the 46th birthday) years of age.
- Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH/NHLBI,
EPR-3 criteria.
- Able to withhold short-acting bronchodilators (e.g., albuterol or ipratropium
bromide) for at least 4 hours prior to clinic visits.
- Baseline FEV1 greater than or equal to 50% of predicted normal.
Exclusion Criteria:
- Any other significant illness/abnormality
- A history of upper or lower respiratory tract infection within 2 weeks
- A history of acute or severe asthma attack requiring ICU admission or ventilatory
support.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Asthma
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Intervention(s)
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Drug: budesonide inhalation suspension
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Drug: MAP0010
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Primary Outcome(s)
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To evaluate the pharmacokinetics of inhaled MAP0010
[Time Frame: Prospective]
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Secondary Outcome(s)
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To evaluate the tolerability of inhaled MAP0010
[Time Frame: Prospective]
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To explore efficacy of inhaled MAP0010
[Time Frame: Prospective]
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Secondary ID(s)
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MAP0010-CL-P202
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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