Trial Outcomes & Findings for A Survey of Adults and Children With Allergic Rhinoconjunctivitis (MK-7243-021) (NCT NCT01535118)
NCT ID: NCT01535118
Last Updated: 2017-03-03
Results Overview
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.
COMPLETED
2765 participants
Within 12 months prior to survey
2017-03-03
Participant Flow
A national probablility sample of 2765 adults \& children (age 5+) who had ever been diagnosed with hay fever, allergic rhinitis, rhinoconjunctivitis, nasal allergies or eye allergies \& had nasal allergy symptoms in the past 12 months or had taken prescription medicine for allergies were interviewed by telephone about their condition \& treatment.
Participant milestones
| Measure |
Adults and Children With Allergic Rhinoconjunctivitis (ARC)
Adults and children with ARC who complete the survey
|
|---|---|
|
Overall Study
STARTED
|
2765
|
|
Overall Study
COMPLETED
|
2765
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Survey of Adults and Children With Allergic Rhinoconjunctivitis (MK-7243-021)
Baseline characteristics by cohort
| Measure |
Adults and Children With ARC
n=2765 Participants
Adults and children with ARC who complete the survey
|
|---|---|
|
Age, Customized
5 to 11 years of age
|
205 participants
n=5 Participants
|
|
Age, Customized
12 to 17 years of age
|
173 participants
n=5 Participants
|
|
Age, Customized
18 to 24 years of age
|
164 participants
n=5 Participants
|
|
Age, Customized
25 to 34 years of age
|
223 participants
n=5 Participants
|
|
Age, Customized
35 to 44 years of age
|
364 participants
n=5 Participants
|
|
Age, Customized
45 to 54 years of age
|
491 participants
n=5 Participants
|
|
Age, Customized
55 to 64 years of age
|
515 participants
n=5 Participants
|
|
Age, Customized
65+ years of age
|
597 participants
n=5 Participants
|
|
Age, Customized
Don't Know/Refused
|
33 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
581 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
333 participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
1851 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 12 months prior to surveyPopulation: The analysis population consisted of all participants who responded to the survey.
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.
Outcome measures
| Measure |
Adults and Children With ARC
n=2765 Participants
Adults and children with ARC who complete the survey
|
|---|---|
|
Percentage of Participants Who Experienced Daily Symptoms Due to Allergic Rhinoconjunctivitis (ARC)
Nasal congestion or stuffed nose
|
41 percentage of participants
|
|
Percentage of Participants Who Experienced Daily Symptoms Due to Allergic Rhinoconjunctivitis (ARC)
Runny nose
|
39 percentage of participants
|
|
Percentage of Participants Who Experienced Daily Symptoms Due to Allergic Rhinoconjunctivitis (ARC)
Postnasal drip
|
38 percentage of participants
|
|
Percentage of Participants Who Experienced Daily Symptoms Due to Allergic Rhinoconjunctivitis (ARC)
Nasal itching
|
29 percentage of participants
|
|
Percentage of Participants Who Experienced Daily Symptoms Due to Allergic Rhinoconjunctivitis (ARC)
Red or itchy eyes
|
26 percentage of participants
|
|
Percentage of Participants Who Experienced Daily Symptoms Due to Allergic Rhinoconjunctivitis (ARC)
Facial pain or pressure
|
12 percentage of participants
|
|
Percentage of Participants Who Experienced Daily Symptoms Due to Allergic Rhinoconjunctivitis (ARC)
Throat itching
|
17 percentage of participants
|
|
Percentage of Participants Who Experienced Daily Symptoms Due to Allergic Rhinoconjunctivitis (ARC)
Repeated sneezing
|
26 percentage of participants
|
PRIMARY outcome
Timeframe: Within 12 months prior to surveyPopulation: The analysis population consisted of all participants who responded to the survey.
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.
Outcome measures
| Measure |
Adults and Children With ARC
n=2765 Participants
Adults and children with ARC who complete the survey
|
|---|---|
|
Percentage of Participants Who Experienced Work or School Absence Due to ARC in the Past 12 Months
|
35 percentage of participants
|
PRIMARY outcome
Timeframe: Within 12 months prior to surveyPopulation: The analysis population consisted of all participants who responded to the survey.
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.
Outcome measures
| Measure |
Adults and Children With ARC
n=2765 Participants
Adults and children with ARC who complete the survey
|
|---|---|
|
Percentage of Participants Who Used Medication to Treat ARC in the Past 12 Months
Over-the-counter medications
|
81 percentage of participants
|
|
Percentage of Participants Who Used Medication to Treat ARC in the Past 12 Months
Prescription medications
|
58 percentage of participants
|
PRIMARY outcome
Timeframe: Within 12 months prior to surveyPopulation: The analysis population consisted of all participants who responded to the survey.
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.
Outcome measures
| Measure |
Adults and Children With ARC
n=2765 Participants
Adults and children with ARC who complete the survey
|
|---|---|
|
Percentage of Participants Who Received Immunotherapy to Treat ARC
Subcutaneous allergy shots
|
21 percentage of participants
|
|
Percentage of Participants Who Received Immunotherapy to Treat ARC
Sublingual allergy drops
|
2 percentage of participants
|
PRIMARY outcome
Timeframe: Within 12 months prior to surveyPopulation: The analysis population consisted of all participants who responded to the survey, received immunotherapy (allergy shots) and had not taken over-the-counter 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.
Outcome measures
| Measure |
Adults and Children With ARC
n=148 Participants
Adults and children with ARC who complete the survey
|
|---|---|
|
Percentage of Participants Who Received Allergy Shots and Required Supplemental Prescription Allergy Medication
|
67 percentage of participants
|
SECONDARY outcome
Timeframe: Within 12 months prior to surveyPopulation: The analysis population consisted of all participants who responded to the survey and received allergy shots.
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.
Outcome measures
| Measure |
Adults and Children With ARC
n=623 Participants
Adults and children with ARC who complete the survey
|
|---|---|
|
Percentage of Participants Who Received Allergy Shots and Had a Co-morbid Condition of Asthma
|
31 percentage of participants
|
Adverse Events
Adults and Children With ARC
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place