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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Refractory Chronic Cough

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Kefang Lai, MD; Phone Number: +86 18928868231; Email: klai@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with chronic cough who visit cough clinics at the First Affiliated Hospital of Guangzhou Medical University would all be screened by the investigator. The eligible subject who provides written informed consent and meet the inclusion/exclusion criteria would be included in this study. Matched healthy controls would be recruited at the same time.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ATP level in sputum	ATP level in induced sputum in subjects with refractory chronic cough and healthy control	2022/04/01-2023/04/02

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ATP cough sensitivity	cough sensitivity for ATP in subjects with refractory chronic cough and healthy control	2022/04/01-2023/04/02

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Anticipated): April 15, 2022
• Primary Completion (Anticipated): April 16, 2023
• Study Completion (Anticipated): May 16, 2023

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: refractory chronic cough, unexplained chronic cough
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: RCC-ATP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No