NCT01318954

Brief Summary

This study will evaluate whether exhaled nitric oxide levels are affected by allergen immunotherapy ("allergy shots"). The investigators' hypothesis is that successful allergen immunotherapy may be accompanied by decreased exhaled nitric oxide levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

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, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2009

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

March 21, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

3.4 years

First QC Date

September 28, 2009

Last Update Submit

October 28, 2015

Conditions

Allergic AsthmaAllergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Effect of allergen immunotherapy on exhaled nitric oxide

    One year

Study Arms (1)

Subjects on allergen immunotherapy

Measurements of Nitric Oxide by NIOX MINO. This device is now FDA approved.

Biological: Allergen immunotherapy

Interventions

Allergen immunotherapyBIOLOGICAL
Subjects on allergen immunotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with allergic asthma and allergic rhinitis undergoing allergen immunotherapy

You may qualify if:

  • Subjects over 18 years old with allergic asthma and/or allergic rhinitis who are beginning allergen desensitization

You may not qualify if:

  • Smokers
  • Subjects of dimished capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.

Bryn Mawr, Pennsylvania, 19010, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Desensitization, Immunologic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Immunosuppression TherapyImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Michele Columbo, M.D.

    Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 28, 2009

First Posted

March 21, 2011

Study Start

January 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

October 29, 2015

Record last verified: 2015-10

Locations

US(1)