NCT00451841

Brief Summary

Cough is the most common complaint for which patients seek medical attention in the United States, accounting for approximately 1 billion dollars in health care expenses annually. Gastroesophageal reflux disease (GERD) is the sole cause of chronic cough in up to 20-40% of all cases. The majority of these patients with GERD-induced cough have no classic "heartburn" symptoms, so this important cause of cough can thus be difficult to detect. Our hypothesis is that changes in exhaled breath condensate (EBC) pH can be used as a sensitive and non-invasive marker to identify subjects with cough caused by acid reflux.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2007

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2007

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

6.3 years

First QC Date

March 22, 2007

Last Update Submit

June 22, 2018

Conditions

CoughGastroesophageal Reflux

Keywords

CoughGastroesophageal refluxExhaled breath condensate

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of esophageal PH changes

    Determine the sensitivity of esophageal PH changes between the group with GERD and the group without GERD.

    24 hours

Study Arms (2)

1

Chronic cough caused by GERD

Device: RTube Exhaled Breath Condensate Collection System

2

Chronic cough without GERD

Device: RTube Exhaled Breath Condensate Collection System

Interventions

RTube Exhaled Breath Condensate Collection SystemDEVICE

Subjects breath through the device to collect exhaled breath condensate

12

Eligibility Criteria

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

Adult patients evaluated for cough in the Lung and Allergy Center of Umass Memorial Medical Center

You may qualify if:

  • age \> 18 years old
  • able to speak and read English
  • chronic cough

You may not qualify if:

  • Cigarette smoking within the past 6 months, or greater than 10 pack year history of prior smoking
  • Any self-reported or clinically diagnosed form of active lung disease, including asthma and emphysema
  • Symptoms of persistent rhinitis within the past three months
  • Dysphagia
  • Symptoms of acute viral upper respiratory tract infection or sinusitis within one month of entry into the study
  • Pregnancy - based on self report
  • Abnormal chest radiograph

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMass Memorial Medical Center, University Campus

Worcester, Massachusetts, 01655, United States

Location

Related Publications (3)

  • Niimi A, Nguyen LT, Usmani O, Mann B, Chung KF. Reduced pH and chloride levels in exhaled breath condensate of patients with chronic cough. Thorax. 2004 Jul;59(7):608-12. doi: 10.1136/thx.2003.012906.

    PMID: 15223872BACKGROUND

  • Hunt J. Exhaled breath condensate pH: reflecting acidification of the airway at all levels. Am J Respir Crit Care Med. 2006 Feb 15;173(4):366-7. doi: 10.1164/rccm.2512001. No abstract available.

    PMID: 16467175BACKGROUND

  • Horvath I, Hunt J, Barnes PJ, Alving K, Antczak A, Baraldi E, Becher G, van Beurden WJ, Corradi M, Dekhuijzen R, Dweik RA, Dwyer T, Effros R, Erzurum S, Gaston B, Gessner C, Greening A, Ho LP, Hohlfeld J, Jobsis Q, Laskowski D, Loukides S, Marlin D, Montuschi P, Olin AC, Redington AE, Reinhold P, van Rensen EL, Rubinstein I, Silkoff P, Toren K, Vass G, Vogelberg C, Wirtz H; ATS/ERS Task Force on Exhaled Breath Condensate. Exhaled breath condensate: methodological recommendations and unresolved questions. Eur Respir J. 2005 Sep;26(3):523-48. doi: 10.1183/09031936.05.00029705.

    PMID: 16135737BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

frozen sputum supernatant and exhaled breath condensate fixed sputum cell preparations

MeSH Terms

Conditions

CoughGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Stephen Krinzman, MD

    University of Massachusetts, Worcester

    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

March 22, 2007

First Posted

March 26, 2007

Study Start

March 1, 2007

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 26, 2018

Record last verified: 2018-06

Locations

US(1)