Indomethacin for Refractory Chronic Cough

NCT03662269 | Unknown Phase 3

• 1 other identifier: YDMX02V2.0
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• frequency of patients'coughs

  1, 7, 14 day

• laryngeal dysfunction score

  1, 7, 14 day

• cough reflex sensitivity

  1, 7, 14, 21 day

Other Outcomes (1)

• change of airway arachidonic acid metabolism

  1, 7, 14, 21 day

Study Arms (2)

indomethacin treatment group

EXPERIMENTAL

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

Drug: indomethacin; Drug: Omeprazole

placebo treatment group

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Omeprazole

Interventions

indomethacin DRUG

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

Also known as: Indometacin sustained-release capsules

indomethacin treatment group

Placebo DRUG

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

placebo treatment group

Omeprazole DRUG

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

indomethacin treatment group; placebo treatment group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ）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

You may not qualify if:

• Patients had any contraindications to indomethacin;
• 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;
• Patients had a respiratory tract infection in the month before randomization;
• Patients were taking an angiotensin-converting enzyme inhibitor;
• Patient were pregnant or breastfeeding, or had impaired kidney function;
• Current and recent smokers (\<6 months' abstinence), or ex-smokers with more than 20 pack-years (20 cigarettes per pack).

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital Of Guangzhou Medical University

Guangzhou, Guangdong, 520120, China

RECRUITING

MeSH Terms

Conditions

Chronic Cough

Interventions

Indomethacin; Omeprazole

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: a randomized, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 7, 2018
• Study Start: October 22, 2018
• Primary Completion: August 15, 2020
• Study Completion: December 30, 2020
• Last Updated: November 26, 2018

Record last verified: 2018-11

Locations

CN (1)