NCT01976117

Brief Summary

Hypothesis: A commercial e-nose (Cyranose 320) is able to detect specific breathprints from patients with COPD and bacterial infection

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

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

June 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 5, 2013

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

6.5 years

First QC Date

October 22, 2013

Last Update Submit

September 7, 2016

Conditions

Pulmonary Disease, Chronic Obstructive (COPD)

Outcome Measures

Primary Outcomes (1)

  • Breathprint in exhaled breath from patients with COPD

    Breathprints will be assessed by discriminant analysis on principal component reduction, resulting in cross-validated accuracy values

    Day 1

Secondary Outcomes (1)

  • Breathprint in exhaled breath from COPD patients with bacterial colonization

    Day 1

Study Arms (1)

enose

EXPERIMENTAL
Device: enose

Interventions

enoseDEVICE
enose

Eligibility Criteria

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

You may qualify if:

  • COPD patients

You may not qualify if:

  • Exacerbation in the last 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Related Publications (1)

  • Sibila O, Garcia-Bellmunt L, Giner J, Rodrigo-Troyano A, Suarez-Cuartin G, Torrego A, Castillo D, Solanes I, Mateus EF, Vidal S, Sanchez-Reus F, Sala E, Cosio BG, Restrepo MI, Anzueto A, Chalmers JD, Plaza V. Airway Mucin 2 Is Decreased in Patients with Severe Chronic Obstructive Pulmonary Disease with Bacterial Colonization. Ann Am Thorac Soc. 2016 May;13(5):636-42. doi: 10.1513/AnnalsATS.201512-797OC.

    PMID: 26882402DERIVED

MeSH Terms

Conditions

Lung DiseasesPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

October 22, 2013

First Posted

November 5, 2013

Study Start

June 1, 2012

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

September 8, 2016

Record last verified: 2016-09

Locations

ES(1)