NCT03638063

Brief Summary

This is a randomized, cross-over, single-blind trial. Eligible patients will be randomly assigned to undergo either capsaicin or adenosine triphosphate (ATP) cough provocation test, followed by a washout period of 2 to 14 days. Participants will be crossed-over to undergo another cough provocation test. Patient would be under observation in the out-patient clinics for \~2 hours following the cough provocation tests in case of severe adverse events.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

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 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 29, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

1.7 years

First QC Date

August 13, 2018

Last Update Submit

February 8, 2020

Conditions

Chronic CoughBronchiectasis

Keywords

Adenosine triphosphateCapsaicincough provocation test

Outcome Measures

Primary Outcomes (1)

  • C5 (Provocant concentration eliciting at least 5 coughs)

    Provocant concentration eliciting at least 5 coughs

    18 months

Secondary Outcomes (6)

  • ED50 (half maximal effective Dose)

    18 months

  • Emax (effective concentration of provocant eliciting maximal cough count)

    18 months

  • potency ratio

    18 months

  • Difference in cough VAS score (a 10-point likert scale for assessing the global severity of cough, no subscale was applied)

    18 months

  • The incidence of adverse events (i.e. dry throat , pharyngeal itching)

    18 months

  • +1 more secondary outcomes

Study Arms (3)

Chronic cough

patients with chronic cough who remain clinically stable

Diagnostic Test: Adenosine TriphosphateDiagnostic Test: capsaicin

Bx

bronchiectasis patients who remain clinically stable

Diagnostic Test: Adenosine TriphosphateDiagnostic Test: capsaicin

Control

healthy controls

Diagnostic Test: Adenosine TriphosphateDiagnostic Test: capsaicin

Interventions

Adenosine TriphosphateDIAGNOSTIC_TEST

Adenosine Triphosphate aerosol

BxChronic coughControl
capsaicinDIAGNOSTIC_TEST

capsaicin aerosol

BxChronic coughControl

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients with chronic cough (including bronchiectasis) who remained clinically stable for at least 4 weeks

You may qualify if:

  • Out-patients of either gender, ex- or never-smokers, aged between 18 and 60 years
  • Cough symptoms lasting for more than 8 weeks
  • Remaining free of acute upper respiratory tract infection for at least 4 weeks
  • Agreed to participate in the trial and signed informed consent.

You may not qualify if:

  • Patients with serious systemic diseases (such as malignant tumors), bullae, severe uncontrolled asthma, and a history of major hemoptysis
  • Systemic antibiotic use (except for maintenance low-dose macrolides) within 4 weeks
  • Pregnancy or lactation
  • Any known history of sensitivity to ATP or capsaicin
  • Poor understanding of the test procedure
  • Diagnosed with cough variant asthma or Eosinophilic bronchitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

Related Publications (4)

  • Fowles HE, Rowland T, Wright C, Morice A. Tussive challenge with ATP and AMP: does it reveal cough hypersensitivity? Eur Respir J. 2017 Feb 8;49(2):1601452. doi: 10.1183/13993003.01452-2016. Print 2017 Feb.

    PMID: 28179439BACKGROUND

  • Guan WJ, Gao YH, Xu G, Lin ZY, Tang Y, Li HM, Lin ZM, Zheng JP, Chen RC, Zhong NS. Capsaicin cough sensitivity and the association with clinical parameters in bronchiectasis. PLoS One. 2014 Nov 19;9(11):e113057. doi: 10.1371/journal.pone.0113057. eCollection 2014.

    PMID: 25409316BACKGROUND

  • Torrego A, Haque RA, Nguyen LT, Hew M, Carr DH, Wilson R, Chung KF. Capsaicin cough sensitivity in bronchiectasis. Thorax. 2006 Aug;61(8):706-9. doi: 10.1136/thx.2005.049767. Epub 2006 Apr 6.

    PMID: 16601085BACKGROUND

  • Fuller RW. Cough provocation tests: their clinical value. Pulm Pharmacol Ther. 2002;15(3):273-6. doi: 10.1006/pupt.2002.0355.

    PMID: 12099777BACKGROUND

MeSH Terms

Conditions

Chronic CoughBronchiectasis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ke-fang Lai, MD

    Guangzhou Institute of Respiratory Health Locations: China, Guangdong First Affiliated Hospital of Guangzhou Medical

    STUDY CHAIR

Central Study Contacts

Wei-jie Guan, MD

CONTACT

+86-13826042052battery203@163.com

Jing jing Yuan, Msc

CONTACT

+86-13502414649jacyyjj@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor; principal investigator (respiratory medicine)

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 20, 2018

Study Start

October 29, 2018

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

February 11, 2020

Record last verified: 2020-02

Locations

CN(1)