NCT01413698

Brief Summary

People with respiratory infection, asthmatic patients and cystic fibrosis (CF) patients suffer from a multitude of pathologies of airways and are often inflicted with chronic cough. Treatment of cough in these patients consists of many types of expectorants, cough suppressors, secretion modifiers, inhaled bronchodilators etc. In addition, chest physical therapy (PT) is often prescribed as part of the treatment regime. The assessment of coughing is currently subjective and based on the symptoms qualitative description as expressed by the patient or parent. Quantitative and objective methods for cough assessment are not available beyond the investigative laboratory and are unique to the specific investigator.

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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

August 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2011

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

August 10, 2011

Status Verified

August 1, 2011

Enrollment Period

4 months

First QC Date

August 9, 2011

Last Update Submit

August 9, 2011

Conditions

Chronic Cough

Outcome Measures

Primary Outcomes (1)

  • Cough count

    recording lasting up to 24 hours

Secondary Outcomes (1)

  • WheezeRate (the proportion of wheezing in the respiratory cycle) , respiratory rate, Inspiratory/Expiratory ratio, SPO2, symptom score (according to a questioner)

    recording lasting up to 24 hours

Study Arms (1)

Patient with chronic cough

Eligibility Criteria

Age2 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic cough

You may qualify if:

  • Age 2-80 years.
  • Patients with significant chronic cough.
  • Patients in hemodynamic stability. Patient is not in respiratory distress.
  • Subject or subject's parents/guardians is able to comprehend and give informed consent for participation in the study.

You may not qualify if:

  • Contraindication to the use of the PulmoTrack™ or performing ARM (Acoustic Respiratory Monitoring).
  • Hemodynamic instability and/or SOB.
  • Concurrent additional major illness.
  • Concurrent participation in any other study.
  • Physician objection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel, 91120, Israel

Location

MeSH Terms

Conditions

Chronic Cough

Condition Hierarchy (Ancestors)

CoughRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 10, 2011

Study Start

September 1, 2011

Primary Completion

January 1, 2012

Study Completion

September 1, 2012

Last Updated

August 10, 2011

Record last verified: 2011-08

Locations

IL(1)