NCT01535118

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,765

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 27, 2014

Completed
Last Updated

March 3, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

February 14, 2012

Results QC Date

December 9, 2013

Last Update Submit

January 18, 2017

Conditions

Keywords

AllergiesImmunotherapy

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Secondary Outcomes (1)

  • Percentage of Participants Who Received Allergy Shots and Had a Co-morbid Condition of Asthma

    Within 12 months prior to survey

Study Arms (1)

Adults and Children with Allergic Rhinoconjunctivitis (ARC)

Adults and children with ARC who complete the survey

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults and children with ARC in the United States.

You may qualify if:

  • 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
  • years of age or older
  • Have a telephone

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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 Immunol. 2014 Apr;112(4):322-8.e1. doi: 10.1016/j.anai.2014.02.006.

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2012

First Posted

February 17, 2012

Study Start

January 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

March 3, 2017

Results First Posted

January 27, 2014

Record last verified: 2017-01