CoughPhase 4TUFNCT02479074
The Utility of feNO in the Differential Diagnosis of Chronic Cough
A Phase 4 study testing Montelukast (High FeNO group), Prednisolon, Montelukast (High FeNO) and Montelukast (Low FeNO group) in people with Cough, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
In this study the investigators wish to explore the difference in 24 hr. cough counts measured using the Hull Automated Cough Counter (HACC), from baseline and after two weeks treatment with either montelukast or prednisolone in patients with an NO measurement of ≥30 ppb at screening. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cough
- What is being tested?
- Montelukast (High FeNO group), Prednisolon, Montelukast (High FeNO) and Montelukast (Low FeNO group)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to 9 Mar 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a history of chronic cough (at least 8 weeks duration)
- Male and female subjects of at least 18 yrs of age
- Subjects able to understand the study and co-operate with the study procedures
- Subjects who consent to their general practitioner (GP) being informed of their study participation.
- Patients with a FeNO of ≥30ppb at presentation to the Chronic cough clinic.( required for entry on to the high FeNO treatment groups)
- Patients with FeNO ≤ 20 ppb at presentation to the chronic cough clinic (required for entry as low FeNO treatment group)
Who cannot join
- Patients with current diagnosis of asthma.
- Female subjects who are pregnant, or lactating, or who are of child bearing potential but are not using contraceptive measures.
- Suffering from any concomitant disease (chronic heart, chronic lung such as; COPD, bronchiectasis and cystic fibrosis, chronic renal, chronic liver or neuromuscular disease or immunosuppression; pneumonia and diabetes) which may interfere with study procedures or evaluation.
- A lower respiratory tract infection 4 weeks prior to entry on to study
- Systemic infections
- Live virus immunisation planned within next 3 months
Show all 16Show fewer
- Subjects with no previous chickenpox who had a recent (<=28 days) close personal contact with chickenpox OR herpes zoster (high FeNO treatment groups only)
- Subjects having recent (<=28 days) exposure to measles (high FeNO treatment groups only)
- Participation in another study (use of investigational product) within 30 days preceding entry on to study.
- Alcohol or drug abuse
- Inability to follow study procedures
- Use of corticosteroids either as inhaled, topical or systemic ≥ 4weeks prior to enrolment
- Subjects with known allergy to prednisolone, montelukast
- Subjects who are taking Angiotensin Converting Enzymes (ACE) inhibitors.
- Current smoker
- Subjects who are taking bronchodilators should be on it for at least 4 weeks on regular dose and carry on the same dose during the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Respiratory Medicine, Clinical trials Unit, Castle Hill Hospital
Cottingham, East Yorkshire, HU16 5JQ
About this study
Official title: The Utility of feNO in the Differential Diagnosis of Chronic Cough: The Response to Anti-inflammatory Therapy With Prednisolone and Montelukast
In this study the investigators wish to explore the difference in 24 hr. cough counts measured using the Hull Automated Cough Counter (HACC), from baseline and after two weeks treatment with either montelukast or prednisolone in patients with an NO measurement of ≥30 ppb at screening.
Read the detailed description
Patients attending the unit as part of their normal outpatients' appointment will be approached with regards to whether interested in taking part in the study. During an outpatients appointment all new chronic cough patients undertake Demographics assessment, full blood count, spirometry test, FeNO measurement and concomitant medication as part of their standard medical care. If a patient decides to take part in this study then at this visit they will have further tests outside their standard medical care including, sputum induction, completion of Leicester cough questionnaire, cough challenge and 24 hr cough monitoring at the screening visit. All the data collected in terms of the clinic visit and additional tests will be analysed in this study.
40 patients with chronic cough and a FeNO≥30 ppb will be enrolled in to the High FeNO Treatment Groups. They will be randomised on a 1:1 ratio to receive either: Montelukast 10 mg daily for four weeks or Prednisolone 20 mg daily for two weeks followed by two weeks Montelukast 10 mg. 20 subjects with chronic cough and a FeNO≤20 ppb will be enrolled in low FeNO Treatment Group will receive montelukast 10 mg for 28 days.
The study consists of five visits to the unit. The first visit will be combined with the patients scheduled clinic appointment. During this visit the investigators will carry out some preliminary assessments such as checking medical history, physical examination, full blood count and vital signs. Demographics assessments, spirometry test, FeNO measurement and concomitant medication will be recorded as per their scheduled clinic visit.
Further testing will be conducted with regards to the study, these tests include: sputum induction, cough challenge, Hull Airways Reflux Questionnaire (HARQ), Leicester Cough Questionnaire (LCQ) and 24h cough monitoring all these tests will be operated at baseline and after 2 weeks and 4 weeks treatment.
Also pregnancy test for women of child bearing potential is required in this study.
At the end of visit 1, patients will receive 14 or 28 days' supply of the randomised study medication.
Visit 2 (13th day) and visit 4 (27th day): Participants will be asked to come to the unit where The Hull Automated Cough Counter will be applied to measure their cough frequency for 24 hours at the end of their treatment.
Visit 3 (14th day) and visit 5 (28th day): Patients will be assessed for any adverse events and any changes in concomitant medication use during the trial and also their vital signs will be checked. After that the FeNo measurement, Pulmonary Function Tests, cough challenge, sputum induction, 24h cough monitoring, Hull Airways Reflux Questionnaire (HARQ) and Leicester Cough Questionnaire (LCQ) will be repeated to compare with the first assessment.
At the end of the study all patients will be reviewed by a chronic cough registrar/consultant as per the standard care as a clinic patient.
- Conditions
- Cough
- Being tested
- Montelukast (High FeNO group), Prednisolon, Montelukast (High FeNO), Montelukast (Low FeNO group)
- Keywords
- Chronic
- Medical subject headings
- Cough, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast (High FeNO group)Drug
Also called Montelukast
Montelukast 10 mg film-coated tablet contains montelukast sodium equivalent to 10 mg montelukast patients to take (oral use) one tablet per day for 28 days
Prednisolon, Montelukast (High FeNO)Drug
Also called Prednisolone and Montelukast
Prednisolone 5 mg, patients to take 4 tablets per day for 14 days then take Montelukast 10 mg tablet per day for another 14 days.
Montelukast (Low FeNO group)Drug
Also called Montelukast
Montelukast 10 mg film-coated tablet contains montelukast sodium equivalent to 10 mg montelukast patients to take one tablet per day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Montelukast (high FeNO) | Active comparator | Montelukast 10 mg film-coated tablet contains montelukast sodium equivalent to 10 mg montelukast patients to take one tablet per day for 28 days Montelukast is a Class B medicine Receives: Drug: Montelukast (High FeNO group) |
| Prednisolone, Montelukast (high FeNO) | Active comparator | Prednisolone 5 mg and montelukast 10 mg. Patients to take Prednisolone 5 mg, 4 tablets per day for 14 days patients to take Montelukast 10 mg film-coated tablet per day for another 14 days Prednisolone is a Class A medicine Montelukast is a Class B medicine Receives: Drug: Prednisolon, Montelukast (High FeNO) |
| Montelukast | Active comparator | Montelukast 10 mg film-coated tablet contains montelukast sodium equivalent to 10 mg montelukast patients to take one tablet per day for 28 days Montelukast is a Class B medicine Receives: Drug: Montelukast (Low FeNO group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hull Automated Cough counter
To determine the difference in objective measure of cough as demonstrated by 24 hr cough counts at the baseline, after 2 and 4 weeks treatment between three treatment groups with an associated elevated FeNO.
Measured: 28 days
Secondary outcomes (6)
HARQ and LCQ questionnaires
Compare change in subjective measures on HARQ and LCQ questionnaires of cough between the treatment groups at the baseline and after 2 week and 4 weeks treatment.
Measured: 28 days
FVC as measured through spirometry
Compare change in FVC between treatment groups at the baseline and after 2 weeks and 4 weeks treatment.
Measured: 28 days
Cough Challenge
Change in cough reflex sensitivity using inhaled citric acid between treatment groups at the baseline and after 2 weeks and 4 weeks treatment.
Measured: 28 days
Sputum Induction
Change in Sputum inflammatory markers between treatment groups at the baseline and after 2 weeks and 4 weeks treatment.
Measured: 28 days
Blood Count
Assess whether previous history of blood eosinophils may predict therapeutic response to anti-inflammatory medication in cough.
Measured: Baseline
FeNO measurement
Assess whether the efficiency of FeNO may help to predict therapeutic response to anti-inflammatory medication in cough.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startJan 2016
- Primary completion10 Feb 2017
- Study completion9 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- Aerocrine AB
- Responsible party
- Sponsor
- Investigators
- Alyn Morice, Professor, Principal investigator, Head of Centre for Cardiovascular and Metabolic Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479074
- Sponsor's protocol ID
- AcadMed1002015
- Acronym
- TUF
- Status last verified
- Jul 2019
- First submitted
- 16 Jun 2015
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Everett CF, Kastelik JA, Thompson RH, Morice AH. Chronic persistent cough in the community: a questionnaire survey. Cough. 2007 Mar 23;3:5. doi: 10.1186/1745-9974-3-5.
PubMed 17381836Ford AC, Forman D, Moayyedi P, Morice AH. Cough in the community: a cross sectional survey and the relationship to gastrointestinal symptoms. Thorax. 2006 Nov;61(11):975-9. doi: 10.1136/thx.2006.060087. Epub 2006 Jun 29.
PubMed 16809412Brightling CE, Ward R, Goh KL, Wardlaw AJ, Pavord ID. Eosinophilic bronchitis is an important cause of chronic cough. Am J Respir Crit Care Med. 1999 Aug;160(2):406-10. doi: 10.1164/ajrccm.160.2.9810100.
PubMed 10430705Korevaar DA, Westerhof GA, Wang J, Cohen JF, Spijker R, Sterk PJ, Bel EH, Bossuyt PM. Diagnostic accuracy of minimally invasive markers for detection of airway eosinophilia in asthma: a systematic review and meta-analysis. Lancet Respir Med. 2015 Apr;3(4):290-300. doi: 10.1016/S2213-2600(15)00050-8. Epub 2015 Mar 20.
PubMed 25801413Sadeghi MH, Wright CE, Hart S, Crooks M, Morice AH. Does FeNO Predict Clinical Characteristics in Chronic Cough? Lung. 2018 Feb;196(1):59-64. doi: 10.1007/s00408-017-0074-6. Epub 2017 Nov 25.
PubMed 29177539Dicpinigaitis PV, Dobkin JB, Reichel J. Antitussive effect of the leukotriene receptor antagonist zafirlukast in subjects with cough-variant asthma. J Asthma. 2002 Jun;39(4):291-7. doi: 10.1081/jas-120002285.
PubMed 12095178Sadeghi MH, Wright CE, Hart S, Crooks M, Morice A. Phenotyping patients with chronic cough: Evaluating the ability to predict the response to anti-inflammatory therapy. Ann Allergy Asthma Immunol. 2018 Mar;120(3):285-291. doi: 10.1016/j.anai.2017.12.004.
PubMed 29508715
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of feNO in the Differential Diagnosis of Chronic Cough: The Response to Anti-inflammatory Therapy With Prednisolone and Montelukast
- ClinicalTrials.gov ID
- NCT02479074
- Acronym / sponsor ID
- TUF / AcadMed1002015
- Conditions
- Cough
- Keywords
- Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- Aerocrine AB
- Study start
- Jan 2016 (actual)
- Primary completion
- 10 Feb 2017 (actual)
- Study completion
- 9 Mar 2017 (actual)
- First posted
- 23 Jun 2015 (estimated)
- 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.
In this study the investigators wish to explore the difference in 24 hr. cough counts measured using the Hull Automated Cough Counter (HACC), from baseline and after two weeks treatment with either montelukast or prednisolone in patients with an NO measurement of ≥30 ppb at screening.
Detailed description
Patients attending the unit as part of their normal outpatients' appointment will be approached with regards to whether interested in taking part in the study. During an outpatients appointment all new chronic cough patients undertake Demographics assessment, full blood count, spirometry test, FeNO measurement and concomitant medication as part of their standard medical care. If a patient decides to take part in this study then at this visit they will have further tests outside their standard medical care including, sputum induction, completion of Leicester cough questionnaire, cough challenge and 24 hr cough monitoring at the screening visit. All the data collected in terms of the clinic visit and additional tests will be analysed in this study.
40 patients with chronic cough and a FeNO≥30 ppb will be enrolled in to the High FeNO Treatment Groups. They will be randomised on a 1:1 ratio to receive either: Montelukast 10 mg daily for four weeks or Prednisolone 20 mg daily for two weeks followed by two weeks Montelukast 10 mg. 20 subjects with chronic cough and a FeNO≤20 ppb will be enrolled in low FeNO Treatment Group will receive montelukast 10 mg for 28 days.
The study consists of five visits to the unit. The first visit will be combined with the patients scheduled clinic appointment. During this visit the investigators will carry out some preliminary assessments such as checking medical history, physical examination, full blood count and vital signs. Demographics assessments, spirometry test, FeNO measurement and concomitant medication will be recorded as per their scheduled clinic visit.
Further testing will be conducted with regards to the study, these tests include: sputum induction, cough challenge, Hull Airways Reflux Questionnaire (HARQ), Leicester Cough Questionnaire (LCQ) and 24h cough monitoring all these tests will be operated at baseline and after 2 weeks and 4 weeks treatment.
Also pregnancy test for women of child bearing potential is required in this study.
At the end of visit 1, patients will receive 14 or 28 days' supply of the randomised study medication.
Visit 2 (13th day) and visit 4 (27th day): Participants will be asked to come to the unit where The Hull Automated Cough Counter will be applied to measure their cough frequency for 24 hours at the end of their treatment.
Visit 3 (14th day) and visit 5 (28th day): Patients will be assessed for any adverse events and any changes in concomitant medication use during the trial and also their vital signs will be checked. After that the FeNo measurement, Pulmonary Function Tests, cough challenge, sputum induction, 24h cough monitoring, Hull Airways Reflux Questionnaire (HARQ) and Leicester Cough Questionnaire (LCQ) will be repeated to compare with the first assessment.
At the end of the study all patients will be reviewed by a chronic cough registrar/consultant as per the standard care as a clinic patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Montelukast (high FeNO) | Active comparator | Drug: Montelukast (High FeNO group)Montelukast 10 mg film-coated tablet contains montelukast sodium equivalent to 10 mg montelukast patients to take one tablet per day for 28 days Montelukast is a Class B medicine |
| Prednisolone, Montelukast (high FeNO) | Active comparator | Drug: Prednisolon, Montelukast (High FeNO)Prednisolone 5 mg and montelukast 10 mg. Patients to take Prednisolone 5 mg, 4 tablets per day for 14 days patients to take Montelukast 10 mg film-coated tablet per day for another 14 days Prednisolone is a Class A medicine Montelukast is a Class B medicine |
| Montelukast | Active comparator | Drug: Montelukast (Low FeNO group)Montelukast 10 mg film-coated tablet contains montelukast sodium equivalent to 10 mg montelukast patients to take one tablet per day for 28 days Montelukast is a Class B medicine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a history of chronic cough (at least 8 weeks duration)
- Male and female subjects of at least 18 yrs of age
- Subjects able to understand the study and co-operate with the study procedures
- Subjects who consent to their general practitioner (GP) being informed of their study participation.
- Patients with a FeNO of ≥30ppb at presentation to the Chronic cough clinic.( required for entry on to the high FeNO treatment groups)
Key exclusion criteria (16 listed)
- Patients with current diagnosis of asthma.
- Female subjects who are pregnant, or lactating, or who are of child bearing potential but are not using contraceptive measures.
- Suffering from any concomitant disease (chronic heart, chronic lung such as; COPD, bronchiectasis and cystic fibrosis, chronic renal, chronic liver or neuromuscular disease or immunosuppression; pneumonia and diabetes) which may interfere with study procedures or evaluation.
- A lower respiratory tract infection 4 weeks prior to entry on to study
- Systemic infections
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 |
|---|---|---|
| Montelukast (High FeNO group)Also: MontelukastMontelukast 10 mg film-coated tablet contains montelukast sodium equivalent to 10 mg montelukast patients to take (oral use) one tablet per day for 28 days | Drug | Montelukast (high FeNO) |
| Prednisolon, Montelukast (High FeNO)Also: Prednisolone and MontelukastPrednisolone 5 mg, patients to take 4 tablets per day for 14 days then take Montelukast 10 mg tablet per day for another 14 days. | Drug | Prednisolone, Montelukast (high FeNO) |
| Montelukast (Low FeNO group)Also: MontelukastMontelukast 10 mg film-coated tablet contains montelukast sodium equivalent to 10 mg montelukast patients to take one tablet per day for 28 days | Drug | Montelukast |
Primary outcome
Hull Automated Cough counter
Time frame: 28 days
To determine the difference in objective measure of cough as demonstrated by 24 hr cough counts at the baseline, after 2 and 4 weeks treatment between three treatment groups with an associated elevated FeNO.
6 secondary outcomes
HARQ and LCQ questionnaires
Time frame: 28 days
FVC as measured through spirometry
Time frame: 28 days
Cough Challenge
Time frame: 28 days
Sputum Induction
Time frame: 28 days
Blood Count
Time frame: Baseline
FeNO measurement
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Background: PubMed 17381836Everett CF, Kastelik JA, Thompson RH, Morice AH. Chronic persistent cough in the community: a questionnaire survey. Cough. 2007 Mar 23;3:5. doi: 10.1186/1745-9974-3-5.
- Background: PubMed 16809412Ford AC, Forman D, Moayyedi P, Morice AH. Cough in the community: a cross sectional survey and the relationship to gastrointestinal symptoms. Thorax. 2006 Nov;61(11):975-9. doi: 10.1136/thx.2006.060087. Epub 2006 Jun 29.
- Background: PubMed 10430705Brightling CE, Ward R, Goh KL, Wardlaw AJ, Pavord ID. Eosinophilic bronchitis is an important cause of chronic cough. Am J Respir Crit Care Med. 1999 Aug;160(2):406-10. doi: 10.1164/ajrccm.160.2.9810100.
- Background: PubMed 25801413Korevaar DA, Westerhof GA, Wang J, Cohen JF, Spijker R, Sterk PJ, Bel EH, Bossuyt PM. Diagnostic accuracy of minimally invasive markers for detection of airway eosinophilia in asthma: a systematic review and meta-analysis. Lancet Respir Med. 2015 Apr;3(4):290-300. doi: 10.1016/S2213-2600(15)00050-8. Epub 2015 Mar 20.
- Background: PubMed 29177539Sadeghi MH, Wright CE, Hart S, Crooks M, Morice AH. Does FeNO Predict Clinical Characteristics in Chronic Cough? Lung. 2018 Feb;196(1):59-64. doi: 10.1007/s00408-017-0074-6. Epub 2017 Nov 25.
- Results publication: PubMed 12095178Dicpinigaitis PV, Dobkin JB, Reichel J. Antitussive effect of the leukotriene receptor antagonist zafirlukast in subjects with cough-variant asthma. J Asthma. 2002 Jun;39(4):291-7. doi: 10.1081/jas-120002285.
- Derived from this study: PubMed 29508715Sadeghi MH, Wright CE, Hart S, Crooks M, Morice A. Phenotyping patients with chronic cough: Evaluating the ability to predict the response to anti-inflammatory therapy. Ann Allergy Asthma Immunol. 2018 Mar;120(3):285-291. doi: 10.1016/j.anai.2017.12.004.
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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.
Alyn Morice, Professor principal investigator
Head of Centre for Cardiovascular and Metabolic Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Montelukast (High FeNO group), Prednisolon, Montelukast (High FeNO) and Montelukast (Low FeNO group) in people with Cough, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 6 inclusion and 16 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: finished, as of the sponsor's last update on 23 Jul 2019. 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 United Kingdom. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hull Automated Cough counter (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02479074, which also lists 7 linked publications.
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 23 Jul 2019.