ATP Level and Cough Sensitivity to ATP in Subjects With Refractory Chronic Cough

Sponsor

Kefang Lai (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05265871

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a prospective case - control study to investigate ATP level in induced sputum and cough sensitivity to ATP in subjects with refractory chronic cough. 60 refractory chronic cough and 30 matched healthy controls were recruited. Medical history records, cough severity assessment, induced sputum for ATP measurement, ATP evoked cough and capsaicin evoked cough were completed. The difference of sputum ATP level between patients and control and the correlation between sputum ATP level and cough sensitivity to ATP were analyzed.

Condition or Disease	Intervention/Treatment	Phase
Refractory Chronic Cough

Study Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

ATP Level in Induced Sputum and Cough Sensitivity to ATP in Subjects With Refractory Chronic Cough

Anticipated Study Start Date :

Apr 15, 2022

Anticipated Primary Completion Date :

Apr 16, 2023

Anticipated Study Completion Date :

May 16, 2023

Arms and Interventions

Arm	Intervention/Treatment
Refractory chronic cough Subjects would be performed induced sputum test, ATP and capsaicin cough provocation test.
Healthy control Subjects would be performed induced sputum test, ATP and capsaicin cough provocation test.

Outcome Measures

Primary Outcome Measures

ATP level in sputum [2022/04/01-2023/04/02]
ATP level in induced sputum in subjects with refractory chronic cough and healthy control

Secondary Outcome Measures

ATP cough sensitivity [2022/04/01-2023/04/02]
cough sensitivity for ATP in subjects with refractory chronic cough and healthy control

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Chronic cough as sole symptom lasting ≥6 months;
No potential causes were identified after full investigations or cough persisted after treatment trials directed to potential causes;
Cough Visual Analogue Score ≥30mm.

Exclusion Criteria:

Current or recent smokers (<6 months abstinence) , those with >20 pack-year smoking history;
With a forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio <60%;
With a history of upper respiratory tract infection or significant change in pulmonary status within 4 weeks.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Kefang Lai

Investigators

Study Chair: Kefang Lai, MD, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kefang Lai, Director of Clinical Research Department, The First Affiliated Hospital of Guangzhou Medical University

ClinicalTrials.gov Identifier:

NCT05265871

Other Study ID Numbers:

RCC-ATP

First Posted:

Mar 4, 2022

Last Update Posted:

Mar 4, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kefang Lai, Director of Clinical Research Department, The First Affiliated Hospital of Guangzhou Medical University

refractory chronic cough, unexplained chronic cough

Additional relevant MeSH terms:

Cough

Study Results

No Results Posted as of Mar 4, 2022