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Indomethacin for Refractory Chronic Cough

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ClinicalTrials.gov Identifier: NCT03662269
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University

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.

Condition or disease Intervention/treatment Phase
Refractory Chronic Cough Drug: indomethacin Drug: Placebo Drug: Omeprazole Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a randomized, double-blind, placebo-controlled trial
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Indomethacin for Refractory Chronic Cough: a Randomized, Double-blind, Placebo-controlled Trial
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : August 15, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: indomethacin treatment group
indomethacin (75mg, bid) + omeprazole (20mg, qd)
Drug: indomethacin
indomethacin (75mg, bid, po, 14days)
Other Name: Indometacin sustained-release capsules

Drug: Omeprazole
placebo (20mg, qd, po, 14days)

Placebo Comparator: placebo treatment group
placebo (75mg, bid) + omeprazole (20mg, qd)
Drug: Placebo
placebo (75mg, bid, po, 14days)

Drug: Omeprazole
placebo (20mg, qd, po, 14days)




Primary Outcome Measures :
  1. Change from Baseline Cough Severity [ Time Frame: 1, 3, 7, 10, 14, 21day ]
    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. )

  2. Change of cough-specific-quality-of-life [ Time Frame: 1, 14, 21 day ]
    Outcome measure: Leicester Cough Questionnaire (LCQ). Score range: 3-21 (Higher values represent a better outcome.)


Secondary Outcome Measures :
  1. frequency of patients'coughs [ Time Frame: 1, 7, 14 day ]
    Outcome measure: cough count in one hour

  2. laryngeal dysfunction score [ Time Frame: 1, 7, 14 day ]
    Outcome measure: Laryngeal dysfunction questionnaire (Higher score represent a better outcome)

  3. cough reflex sensitivity [ Time Frame: 1, 7, 14, 21 day ]
    Outcome measure: LogC5 of Capsaicin cough challenge


Other Outcome Measures:
  1. change of airway arachidonic acid metabolism [ Time Frame: 1, 7, 14, 21 day ]
    Concentration of PGE2, PGF2α, PGD2, 6-Keto-PGF1α, TXB2, leukotriene B4(LTB4) and cys-LTs in induced sputum



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662269


Locations
China, Guangdong
The First Affiliated Hospital Of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 520120
Contact: Kefang Lai, PHD    83062893 ext 020    klai@163.com   
Principal Investigator: Kefang Lai, PHD         
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University

Responsible Party: Kefang Lai, professor, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT03662269     History of Changes
Other Study ID Numbers: YDMX02V2.0
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Study Protocol Statistical Analysis Plan (SAP)

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Omeprazole
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Indomethacin
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors