Indomethacin for Refractory Chronic Cough

Refractory Chronic Cough Clinical Trial

Official title:

Indomethacin for Refractory Chronic Cough: a Randomized, Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03662269
• Other study ID #: YDMX02V2.0
• Status: Recruiting
• Phase: Phase 3
• 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
• 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).

Related Conditions & MeSH terms

• Cough
• Refractory Chronic Cough

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