Indomethacin for Refractory Chronic Cough

NCT ID: NCT03662269

Last Updated: 2018-11-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-22
• Study Completion Date: 2020-12-30

Brief 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.

Conditions

Refractory Chronic Cough

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

indomethacin treatment group

indomethacin (75mg, bid) + omeprazole (20mg, qd)

Group Type: EXPERIMENTAL

indomethacin

Intervention Type: DRUG

indomethacin (75mg, bid, po, 14days)

Omeprazole

Intervention Type: DRUG

placebo (20mg, qd, po, 14days)

placebo treatment group

placebo (75mg, bid) + omeprazole (20mg, qd)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo (75mg, bid, po, 14days)

Omeprazole

Intervention Type: DRUG

placebo (20mg, qd, po, 14days)

Interventions

indomethacin

indomethacin (75mg, bid, po, 14days)

Intervention Type: DRUG

Placebo

placebo (75mg, bid, po, 14days)

Intervention Type: DRUG

Omeprazole

placebo (20mg, qd, po, 14days)

Intervention Type: DRUG

Other Intervention Names

Indometacin sustained-release capsules

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Kefang Lai

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital Of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Kefang Lai, PHD

Role: primary

klai@163.com

83062893 ext. 020

Other Identifiers

YDMX02V2.0

Identifier Type: -

Identifier Source: org_study_id