Allergic RhinoconjunctivitisAIRSNCT01535118
A Survey of Adults and Children With Allergic Rhinoconjunctivitis (MK-7243-021)
An observational study of Allergic Rhinoconjunctivitis, run by ALK-Abelló A/S.
Trial summary
This study will gather information on allergic rhinoconjunctivitis from surveys completed by adults and children. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- How many people
- 2,765 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to May 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adults and children with ARC in the United States.
Who may be able to join
- 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
Who cannot join
- If less than 18 years old and there is no adult available that is knowledgeable about the participant's health
About this study
Official title: National Allergies, Immunotherapy and RhinoConjunctivitis Survey in America
This study will gather information on allergic rhinoconjunctivitis from surveys completed by adults and children.
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- Allergies, Immunotherapy
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults and Children with Allergic Rhinoconjunctivitis (ARC) | Adults and children with ARC who complete the survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 12 months prior to survey
Secondary outcomes (1)
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.
Measured: Within 12 months prior to survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinoconjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 2,765 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535118
- Sponsor's protocol ID
- 7243-021
- Acronym
- AIRS
- Status last verified
- Jan 2017
- First submitted
- 14 Feb 2012
- Last updated
- 3 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24679733
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Allergies, Immunotherapy and RhinoConjunctivitis Survey in America
- ClinicalTrials.gov ID
- NCT01535118
- Acronym / sponsor ID
- AIRS / 7243-021
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- Allergies, Immunotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,765 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 Feb 2012 (estimated)
- Results
- Posted 27 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will gather information on allergic rhinoconjunctivitis from surveys completed by adults and children.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults and Children with Allergic Rhinoconjunctivitis (ARC) | – | –Adults and children with ARC who complete the survey |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and children with ARC in the United States.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- If less than 18 years old and there is no adult available that is knowledgeable about the participant's health
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants Who Experienced Daily Symptoms Due to Allergic Rhinoconjunctivitis (ARC)
Time frame: Within 12 months prior to 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.
Percentage of Participants Who Experienced Work or School Absence Due to ARC in the Past 12 Months
Time frame: Within 12 months prior to 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.
Percentage of Participants Who Used Medication to Treat ARC in the Past 12 Months
Time frame: Within 12 months prior to 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.
Percentage of Participants Who Received Immunotherapy to Treat ARC
Time frame: Within 12 months prior to 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.
Percentage of Participants Who Received Allergy Shots and Required Supplemental Prescription Allergy Medication
Time frame: Within 12 months prior to survey
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.
1 secondary outcome
Percentage of Participants Who Received Allergy Shots and Had a Co-morbid Condition of Asthma
Time frame: Within 12 months prior to survey
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24679733Blaiss 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinoconjunctivitis, run by ALK-Abelló A/S.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Experienced Daily Symptoms Due to Allergic Rhinoconjunctivitis (ARC) (time frame: Within 12 months prior to survey). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01535118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.