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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01535118
Other study ID # 7243-021
Secondary ID
Status Completed
Phase N/A
First received February 14, 2012
Last updated February 25, 2015
Start date January 2012
Est. completion date May 2012

Study information

Verified date February 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

This study will gather information on allergic rhinoconjunctivitis from surveys completed by adults and children.


Recruitment information / eligibility

Status Completed
Enrollment 2765
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years and older
Eligibility Inclusion Criteria:

- Diagnosed with hay fever, rhinitis or nasal and/or eye allergies and display symptoms of sneezing, itching, watery eyes, nasal congestion, or other nasal or eye allergy symptoms over the past 12 months OR take any medication for their hay fever, rhinitis, nasal or eye allergies

- 5 years of age or older

- Have a telephone

Exclusion Criteria:

- If less than 18 years old and there is no adult available that is knowledgeable about the participant's health

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Blaiss MS, Dykewicz MS, Skoner DP, Smith N, Leatherman B, Craig TJ, Bielory L, Walstein N, Allen-Ramey F. Diagnosis and treatment of nasal and ocular allergies: the Allergies, Immunotherapy, and RhinoconjunctivitiS (AIRS) surveys. Ann Allergy Asthma Immun — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Who Experienced Daily Symptoms Due to Allergic Rhinoconjunctivitis (ARC) Participants were asked about the frequency and severity of ARC symptoms when allergies were at their worst. The percentages of participants who experienced different symptoms of ARC on a daily basis when allergies were at their worst were calculated. Within 12 months prior to survey No
Primary Percentage of Participants Who Experienced Work or School Absence Due to ARC in the Past 12 Months Participants were asked about the impact of ARC on loss of work and school time. The percentage of participants who experienced work or school absence due to ARC in the prior 12 months was calculated. Within 12 months prior to survey No
Primary Percentage of Participants Who Used Medication to Treat ARC in the Past 12 Months Participants were asked about prescription and over-the-counter medication use for ARC. The percentages of participants who used prescription and/or over-the-counter medication to treat ARC in the past 12 months were calculated. Within 12 months prior to survey No
Primary Percentage of Participants Who Received Immunotherapy to Treat ARC Participants who had ever received immunotherapy for ARC were asked about the type of immunotherapy - subcutaneous or sublingual - received. The percentage of participants who received immunotherapy to treat ARC was calculated. Within 12 months prior to survey No
Primary Percentage of Participants Who Received Allergy Shots and Required Supplemental Prescription Allergy Medication Participants who received subcutaneous immunotherapy (allergy shots) were asked about prescription and over-the-counter medication use. The percentage of participants who received allergy shots to treat ARC, had not taken over-the-counter allergy medication and required supplemental prescription allergy medication for ARC was calculated. Within 12 months prior to survey No
Secondary Percentage of Participants Who Received Allergy Shots and Had a Co-morbid Condition of Asthma Participants were asked about co-morbid health conditions. The percentage of participants who had received allergy shots to treat ARC and had asthma was calculated. Within 12 months prior to survey Yes
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