NCT01631162

Brief Summary

The investigators assume that by analysis of different volatile organic compounds in the breath, using nanotechnology, the investigators will be able to identify a unique respiratory signature of different diseases including asthma, chronic obstructive pulmonary disease (COPD) and pulmonary hypertension.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started May 2012

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 6, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 29, 2012

Status Verified

June 1, 2012

Enrollment Period

2.6 years

First QC Date

June 6, 2012

Last Update Submit

June 28, 2012

Conditions

AsthmaChronic Obstructive Lung Disease

Keywords

AsthmaCOPD

Outcome Measures

Primary Outcomes (1)

  • Volatile organic compounds signature measured by mass spectrometer and electronic signal measured by the electronic nose, difference between the study groups at one and 12 months

    up to 12 months

Study Arms (1)

lung disease

NO INTERVENTION
Other: Breath sample in all patients

Interventions

Breath sample in all patientsOTHER

Breath sample will be collected by a special nylon bag

Also known as: Breath samples for electronic nose
lung disease

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of asthma according to the American Thoracic Society guidelines.
  • Diagnosis of chornic obstructive pulmonary disease according to the American Thoracic Society, guidelines.
  • Diagnosis of pulmoanry hypertension according to the American Thoracic Society guidelins
  • Age-18-85 year old

You may not qualify if:

  • known carriers of infectious diseases: HIV, hepatitis B, C
  • pregnancy
  • History of lung cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmel Medical Center

Haifa, 34362, Israel

RECRUITING

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic Obstructive

Interventions

Electronic Nose

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesElectrical Equipment and Supplies

Study Officials

  • Amer Ubaid

    Carmel Medical Center

    STUDY DIRECTOR

  • Yochai Adir, PI

    Carmel Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yochai Adir, MD

CONTACT

972-4-8250517YOCHAIAD@CLALIT.ORG.IL

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2012

First Posted

June 29, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

June 29, 2012

Record last verified: 2012-06

Locations

IL(1)