Refractory Chronic CoughPhase 3NCT03662269
Indomethacin for Refractory Chronic Cough
A Phase 3 study testing indomethacin and Omeprazole in people with Refractory Chronic Cough, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Refractory Chronic Cough
- What is being tested?
- indomethacin and Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2018to 30 Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, 520120
Kefang Lai, PHD, 83062893 ext. 020, klai@163.com
Kefang Lai, PHD
About this study
Official title: Indomethacin for Refractory Chronic Cough: a Randomized, Double-blind, Placebo-controlled Trial
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
- Being tested
- indomethacin, Placebo, Omeprazole
- Medical subject headings
- Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indomethacinDrug
Also called Indometacin sustained-release capsules
indomethacin (75mg, bid, po, 14days)
PlaceboDrug
placebo (75mg, bid, po, 14days)
OmeprazoleDrug
placebo (20mg, qd, po, 14days)
| Study group | Role | What they receive |
|---|---|---|
| indomethacin treatment group | Experimental | indomethacin (75mg, bid) + omeprazole (20mg, qd) Receives: Drug: indomethacin; Drug: Omeprazole |
| placebo treatment group | Placebo comparator | placebo (75mg, bid) + omeprazole (20mg, qd) Receives: Drug: Placebo; Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. )
Measured: 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.)
Measured: 1, 14, 21 day
Secondary outcomes (3)
frequency of patients'coughs
Outcome measure: cough count in one hour
Measured: 1, 7, 14 day
laryngeal dysfunction score
Outcome measure: Laryngeal dysfunction questionnaire (Higher score represent a better outcome)
Measured: 1, 7, 14 day
cough reflex sensitivity
Outcome measure: LogC5 of Capsaicin cough challenge
Measured: 1, 7, 14, 21 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start22 Oct 2018
- Primary completion15 Aug 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Chronic CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomized, double-blind, placebo-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662269
- Sponsor's protocol ID
- YDMX02V2.0
- Status last verified
- Nov 2018
- First submitted
- 31 Aug 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study Protocol Statistical Analysis Plan (SAP)
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indomethacin for Refractory Chronic Cough: a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03662269
- Acronym / sponsor ID
- YDMX02V2.0
- Conditions
- Refractory Chronic Cough
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 15 Aug 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- a randomized, double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| indomethacin treatment group | Experimental | Drug: indomethacin, Drug: Omeprazoleindomethacin (75mg, bid) + omeprazole (20mg, qd) |
| placebo treatment group | Placebo comparator | Drug: Placebo, Drug: Omeprazoleplacebo (75mg, bid) + omeprazole (20mg, qd) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indomethacinAlso: Indometacin sustained-release capsulesindomethacin (75mg, bid, po, 14days) | Drug | indomethacin treatment group |
| Placeboplacebo (75mg, bid, po, 14days) | Drug | placebo treatment group |
| Omeprazoleplacebo (20mg, qd, po, 14days) | Drug | indomethacin treatment group, placebo treatment group |
Primary outcome
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. )
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.)
3 secondary outcomes
frequency of patients'coughs
Time frame: 1, 7, 14 day
laryngeal dysfunction score
Time frame: 1, 7, 14 day
cough reflex sensitivity
Time frame: 1, 7, 14, 21 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
- Individual participant dataSharing planned: Undecided. Study Protocol Statistical Analysis Plan (SAP)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing indomethacin and Omeprazole in people with Refractory Chronic Cough, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Cough Severity (time frame: 1, 3, 7, 10, 14, 21day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018; AzTrials last refreshed its copy on 29 Oct 2026.