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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: |
NCT01008397 |
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Date of registration:
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27/10/2009 |
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Primary sponsor: |
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Public title:
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Study of AHIST in Seasonal Allergic Rhinitis Patients
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Scientific title:
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Phase 1 Study of AHIST in Seasonal Allergic Rhinitis Patients |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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21 |
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Recruitment status: |
Suspended |
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URL:
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http://clinicaltrials.gov/show/NCT01008397 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Stephen J Pollard, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Family Allergy and Asthma Research Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Male and females of any ethnic group between 18 and 60 years of age.
2. History of moderate to severe Seasonal Allergic Rhinitis (SAR) for at least two
years.
3. Subjects' symptoms resulting from the irritation of sinus, nasal and upper
respiratory tract tissues will include the five symptoms ("S5") that are the focus of
this study: nasal congestion, rhinorrhea, nasal itching, sneezing, and post nasal
drip.
4. Prior to study drug administration, subjects' good health will be confirmed by
medical history, physical examination, and urine dip pregnancy test.
5. Allergic hypersensitivity will be confirmed by an appropriate test as deemed
necessary by the physician or well established patient medical history.
Exclusion Criteria:
1. Pregnancy or lactation.
2. Immunotherapy unless at stable maintenance dose.
3. Presence of a medical condition that might interfere with treatment evaluation or
require a change in therapy including but not limited to high blood pressure or
urinary retention problems.
4. Alcohol dependence.
5. Use of any other investigational drug in the previous month.
6. Subjects presenting with asthma requiring corticosteroid treatment.
7. Subjects with multiple drug allergies.
8. Subjects known to have an idiosyncratic reaction to any of the ingredients in AHIST.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rhinitis, Allergic, Seasonal
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Intervention(s)
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Drug: AHIST NDC#58407-012-01
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Primary Outcome(s)
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To gather pharmacodynamic measurements and assess blood levels (five draws) of the active ingredient in AHIST over the dosage interval period of 12 hours.
[Time Frame: April 2011]
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Secondary Outcome(s)
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To report any side effects or adverse drug reactions and rate the severity of incidence.
[Time Frame: April 2011]
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Secondary ID(s)
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AHIST IND
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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