Asthma in the Elderly: The Role of Exhaled Nitric Oxide M... | NCT00939354

Studies
Asthma in the Elderly: The Role of Exhaled Nitric Oxide Measurements

NCT00939354

Sponsor

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

Status

Completed

Last Update Posted

Oct 29, 2015Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Asthma

Interventions

Not provided

Countries

Not provided

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

Jul 2009

Primary Completion Date

Feb 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Jul 14, 2009

First Submission Date that Met QC Criteria

Jul 14, 2009

First Posted Date

Jul 15, 2009Estimated

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., Co-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 investigate the importance of exhaled nitric oxide measurements in subjects with asthma age 65 and older. This group of patients has been ignored in most previous asthma studies.

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

30Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Exhaled Nitric Oxide (FENO) levels and their changes with time		One year

Secondary Outcomes

Measure	Description	Time Frame
Correlations of FENO with subjects' demographics, comorbidities, treatment, symptoms, or spiromentric values		One year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with asthma over the age of 65 followed in our practice, non-smokers and able to give informed consent to participate in the study

Exclusion Criteria:

Smokers, subjects of diminished mental capacity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Subjects with asthma over the age of 65 who are currently followed in our practice

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Albert S Rohr, M.D.	Rohr and Columbo Associates	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided