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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03662269
Other study ID # YDMX02V2.0
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date October 22, 2018
Est. completion date December 30, 2020

Study information

Verified date November 2018
Source The First Affiliated Hospital of Guangzhou Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Chronic cough is a common complain of patients in respiratory clinic and its global prevalence was up to 9.6%. Persistent cough of unexplained origin is a significant health issue that occurs in up to 5% to 10% of patients seeking medical assistance for a chronic cough and from 0% to 46% of patients referred to specialty cough clinics. Previous studies showed that sputum prostaglandin D2( PGD2) and prostaglandin E2 (PGE2) concentrations were significantly higher in chronic cough. And some research showed that Inhaled PGE2 /PGF2α /PGD2 / PGI2/ 6-oxo-PGF1a could induced cough. And PGE2 /PGF2α/PGI2/thromboxane A2 (TXA2) also increased the sensitivity of the cough reflex. All these five primary prostaglandins were synthesized though the metabolism of arachidonic acid via the cyclooxygenase pathway. Indomethacin is a strong inhibitor of cyclooxygenase , which decrease the level of prostaglandins in airway. The investigator's preliminary study showed that indomethacin could relieve cough and improve cough sensitivity of some patients with refractory cough. Therefore this randomized, double-blind, placebo-controlled trial were designed to investigate whether indomethacin can relive cough in patients with refractory cough and to explore the possible mechanism of indomethacin in improving cough in patients with refractory cough.


Recruitment information / eligibility

Status Recruiting
Enrollment 84
Est. completion date December 30, 2020
Est. primary completion date August 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

1)18 years old = age = 60 years old, male or female; 2)Chronic cough lasting more than 8 weeks as the sole or predominant symptom, without abnormalities on chest radiograph; 3)Chronic cough remains after investigation and supervised therapeutic trial(s) conducted according to "Clinical Practice Guidelines for Diagnosis and Management of Cough (2015)" 4)Cough VAS (0-100mm) = 30 mm

Exclusion Criteria:

1. Patients had any contraindications to indomethacin;

2. Patients had active respiratory disease (such as chronic obstructive pulmonary Disease or untreated asthma), or moderate or above obstructive or restrictive or mixed pulmonary ventilation dysfunction;

3. Patients had a respiratory tract infection in the month before randomization;

4. Patients were taking an angiotensin-converting enzyme inhibitor;

5. Patient were pregnant or breastfeeding, or had impaired kidney function;

6. Current and recent smokers (<6 months' abstinence), or ex-smokers with more than 20 pack-years (20 cigarettes per pack).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
indomethacin
indomethacin (75mg, bid, po, 14days)
Placebo
placebo (75mg, bid, po, 14days)
Omeprazole
placebo (20mg, qd, po, 14days)

Locations

Country Name City State
China The First Affiliated Hospital Of Guangzhou Medical University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other change of airway arachidonic acid metabolism Concentration of PGE2, PGF2a, PGD2, 6-Keto-PGF1a, TXB2, leukotriene B4(LTB4) and cys-LTs in induced sputum 1, 7, 14, 21 day
Primary Change from Baseline Cough Severity Outcome measure: Cough visual analogue scales (Cough VAS). Score range: 0-100mm (0 mean no cough, 100 represent that cough is the most severe in his/her life. Scoring higher on cough VAS mean more severe cough he/she has. ) 1, 3, 7, 10, 14, 21day
Primary Change of cough-specific-quality-of-life Outcome measure: Leicester Cough Questionnaire (LCQ). Score range: 3-21 (Higher values represent a better outcome.) 1, 14, 21 day
Secondary frequency of patients'coughs Outcome measure: cough count in one hour 1, 7, 14 day
Secondary laryngeal dysfunction score Outcome measure: Laryngeal dysfunction questionnaire (Higher score represent a better outcome) 1, 7, 14 day
Secondary cough reflex sensitivity Outcome measure: LogC5 of Capsaicin cough challenge 1, 7, 14, 21 day
See also
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