The Effect of Allergen Immunotherapy on Exhaled Nitric Ox... | NCT01318954

Studies
The Effect of Allergen Immunotherapy on Exhaled Nitric Oxide in Adult Patients With Asthma and Allergic Rhinitis

NCT01318954

Sponsor

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

Status

Completed

Last Update Posted

Oct 29, 2015Estimated

Enrollment

17Actual

Phase

Not provided

Conditions

Allergic Asthma
Allergic Rhinitis

Interventions

Allergen immunotherapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Sep 28, 2009

First Submission Date that Met QC Criteria

Mar 17, 2011

First Posted Date

Mar 21, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2015

Last Update Posted Date

Oct 29, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michele Columbo, M.D., Principal Investigator, Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.Principal Investigator

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects on allergen immunotherapy		Measurements of Nitric Oxide by NIOX MINO. This device is now FDA approved.	Biological: Allergen immunotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Allergen immunotherapy	Biological		Subjects on allergen immunotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect of allergen immunotherapy on exhaled nitric oxide		One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Smokers
Subjects of dimished capacity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects with allergic asthma and allergic rhinitis undergoing allergen immunotherapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michele Columbo, M.D.	Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.		Bryn Mawr	Pennsylvania	19010	United States

Condition Browse Module

MeSH Terms

ID	Term
D065631	Rhinitis, Allergic

Ancestor Terms

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003888	Desensitization, Immunologic

Ancestor Terms

ID	Term
D007165	Immunosuppression Therapy
D007167	Immunotherapy
D056747	Immunomodulation
D001691	Biological Therapy

Browse Leaves

Not provided

Browse Branches

Not provided