CoughingPhase 4NCT02655562
Fractional Concentration of Exhaled NO(FeNO) to Direct The Treatment of Sub-acute Cough
A Phase 4 study testing Montelukast in people with Coughing, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
Cough is a common symptom that leads patients worldwide to seek medical attention. Subacute cough refers to a cough of 3-8-week duration, and is typically refractory to standard anti-tussive therapy, and a tendency to spontaneous healing was common. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coughing
- What is being tested?
- Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Feb 2026
- 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
- Cough is the main or only clinical symptom and was persistent for 3-8 weeks Chest X-ray reveals no noticeable pathological changes
- more than 18 year old, regardless of gender and ethical background
- Not taking angiotensin-converting enzyme inhibitor
- Patients must join the programme voluntarily and are able to attend examination and follow-up sessions
Who cannot join
- Patients diagnosed with allergic rhinitis, chronic nasosinusitis or bacterial respiratory tract infections
- Patients diagnosed with severe reportorial disease of other severe systemic disease
- Patients who are allergic to any drugs to be tested
- Patients who are non-cooperative during examination sessions or other steps of the trial
- Patients who are not able to or refuse to sign consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fractional Concentration of Exhaled NO(FeNO) to Direct The Treatment of Sub-acute Cough：A Prospective, Open Label, Randomized and Placebo-Controlled Trial
Cough is a common symptom that leads patients worldwide to seek medical attention. Subacute cough refers to a cough of 3-8-week duration, and is typically refractory to standard anti-tussive therapy, and a tendency to spontaneous healing was common. Few clinical trials have evaluated therapeutic options for subacute cough. Airway inflammation is an important feature of most of subacute cough, Cysteinyl leukotrienes and FeNO correlates with airway inflammation. Subacute cough often represents a prolonged post-viral response. Cysteinyl leukotrienes increase in virus infection. Airway inflammation induce epithelial cells produce iNOS(inducible nitric oxide synthase,iNOS), and FeNO increase in theory. Montelukast is a cysteinyl leukotriene type 1 receptor antagonist that is reported to improve cough16 and reduces FENO and prevents increases in FENO during reduction of inhaled corticosteroid dose, But A meta-analysis of the effectiveness of LTRA( leukotriene receptor antagonist,LTRA)in treating children with prolonged non-specific cough concluded that, with the lack of evidence, the routine use of LTRA in treating children with non-specific cough cannot be recommended. A randomised, placebo-controlled trial showed montelukast is not an effective treatment for postinfectious cough. Non-specialists or general practitioners of Japan prescribe LTRA very often, which increase. The aim is to research whether FeNO can be used as a biomarker to direct montelukast treatment and optimize treatment regimen of sub-acute cough.
Read the detailed description
This project is a prospective, open label, randomized and controlled trial. All subacute cough patients that met the inclusion/exclusion criteria were recruited after signing the consent form. Patients were randomized into biomarker treatment armand standard treatment arm.
Patients in biomarker treatment arm and FENO≥25ppb were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) . Patients in biomarker reatment arm and FENO<25ppb were given placebo (p.o., 10mg, qd). Patients in standard treatment arm and FENO≥25ppb were given placebo (p.o., 10mg, qd). Patients in standard treatment arm and FENO<25ppb were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) .All treatment regimens lasted for 10 days and no other antitussive/decongestant or bronchodilators are given to any patients.
Examine results of all patients from all arms were recorded before and after the 10 day treatment. The examine recorded are FENO levels, cough symptom assessment, cough visual assessment, Leicester cough questionnaire, total white blood cell count, neutrophil blood percentage, eosinophil blood percentage. Patient cough free days after treatment and Montelukast Sodium Tablets . Follow up was carried out at the 8th week after first record of symptom and 2 month after treatment.
- Conditions
- Coughing
- Being tested
- Montelukast
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Also called Placebo
Patients in biomarker treatment arm and FENO≥25ppb were given Montelukast Sodium Tablets (p.o., 10mg, qd) . Patients in biomarker reatment arm and FENO<25ppb were given placebo (p.o., 10mg, qd).
Patients in standard treatment arm and FENO≥25ppb were given placebo (p.o., 10mg, qd). Patients in standard treatment arm and FENO<25ppb were given Montelukast Sodium Tablets (p.o., 10mg, q.d.).All treatment regimens lasted for 10 days and no other antitussive/decongestant or bronchodilators are given to any patients.
| Study group | Role | What they receive |
|---|---|---|
| biomarker treatment arm | Experimental | Patients in biomarker treatment arm and FENO≥25ppb were given Montelukast Sodium Tablets (p.o., 10mg, qd) . Patients in biomarker reatment arm and FENO<25ppb were given placebo (p.o., 10mg, qd).All treatment regimens lasted for 10 days and no other antitussive/decongestant or bronchodilators are given to any patients. Receives: Drug: Montelukast |
| standard treatment arm | Placebo comparator | Patients in standard treatment arm and FENO≥25ppb were given placebo (p.o., 10mg, qd). Patients in standard treatment arm and FENO<25ppb were given Montelukast Sodium Tablets (p.o., 10mg, q.d.).All treatment regimens lasted for 10 days and no other antitussive/decongestant or bronchodilators are given to any patients. Receives: Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leicester cough questionnaire
Change in Leicester Cough Questionnaire(LCQ) total and domain scores at 10 days post randomisation
Measured: 10 days
Secondary outcomes (1)
cough visual assessment
Change in Leicester Cough Questionnaire(LCQ) physical,psychological and social domain scores at 10 days post randomisation
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2024 (estimated)
- Study completionFeb 2026 (estimated)
Why it stopped: There are difficulties in recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for CoughingStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingming Jiang, Beijing Chao Yang Hospital
- Investigators
- Kewu Huang, M.D., Study chair, Respiratory Medicine Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655562
- Sponsor's protocol ID
- Beijing Chao Yang Hospital
- Status last verified
- Jul 2022
- First submitted
- 30 Dec 2015
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Wedde-Beer K, Hu C, Rodriguez MM, Piedimonte G. Leukotrienes mediate neurogenic inflammation in lungs of young rats infected with respiratory syncytial virus. Am J Physiol Lung Cell Mol Physiol. 2002 May;282(5):L1143-50. doi: 10.1152/ajplung.00323.2001.
PubMed 11943681van Schaik SM, Tristram DA, Nagpal IS, Hintz KM, Welliver RC 2nd, Welliver RC. Increased production of IFN-gamma and cysteinyl leukotrienes in virus-induced wheezing. J Allergy Clin Immunol. 1999 Apr;103(4):630-6. doi: 10.1016/s0091-6749(99)70235-6.
PubMed 10200012Spector SL, Tan RA. Effectiveness of montelukast in the treatment of cough variant asthma. Ann Allergy Asthma Immunol. 2004 Sep;93(3):232-6. doi: 10.1016/S1081-1206(10)61493-7.
PubMed 15478381Kato A, Schleimer RP. Beyond inflammation: airway epithelial cells are at the interface of innate and adaptive immunity. Curr Opin Immunol. 2007 Dec;19(6):711-20. doi: 10.1016/j.coi.2007.08.004. Epub 2007 Oct 24.
PubMed 17928212Mincheva RK, Kralimarkova TZ, Rasheva M, Dimitrov Z, Nedeva D, Staevska M, Papochieva V, Perenovska P, Bacheva K, Dimitrov VD, Popov TA. A real - life observational pilot study to evaluate the effects of two-week treatment with montelukast in patients with chronic cough. Cough. 2014 Mar 20;10(1):2. doi: 10.1186/1745-9974-10-2.
PubMed 24649919Birring SS, Prudon B, Carr AJ, Singh SJ, Morgan MD, Pavord ID. Development of a symptom specific health status measure for patients with chronic cough: Leicester Cough Questionnaire (LCQ). Thorax. 2003 Apr;58(4):339-43. doi: 10.1136/thorax.58.4.339.
PubMed 12668799Sandrini A, Ferreira IM, Gutierrez C, Jardim JR, Zamel N, Chapman KR. Effect of montelukast on exhaled nitric oxide and nonvolatile markers of inflammation in mild asthma. Chest. 2003 Oct;124(4):1334-40. doi: 10.1378/chest.124.4.1334.
PubMed 14555563Wang K, Birring SS, Taylor K, Fry NK, Hay AD, Moore M, Jin J, Perera R, Farmer A, Little P, Harrison TG, Mant D, Harnden A. Montelukast for postinfectious cough in adults: a double-blind randomised placebo-controlled trial. Lancet Respir Med. 2014 Jan;2(1):35-43. doi: 10.1016/S2213-2600(13)70245-5. Epub 2013 Dec 2.
PubMed 24461900Kwon NH, Oh MJ, Min TH, Lee BJ, Choi DC. Causes and clinical features of subacute cough. Chest. 2006 May;129(5):1142-7. doi: 10.1378/chest.129.5.1142.
PubMed 16685003Lim KG, Mottram C. The use of fraction of exhaled nitric oxide in pulmonary practice. Chest. 2008 May;133(5):1232-42. doi: 10.1378/chest.07-1712.
PubMed 18460522Tarnoky AL. Albumin. Ann Clin Biochem. 1981 Mar;18 (Pt 2):61-3. doi: 10.1177/000456328101800201. No abstract available.
PubMed 7259071Sato S, Saito J, Sato Y, Ishii T, Xintao W, Tanino Y, Ishida T, Munakata M. Clinical usefulness of fractional exhaled nitric oxide for diagnosing prolonged cough. Respir Med. 2008 Oct;102(10):1452-9. doi: 10.1016/j.rmed.2008.04.018. Epub 2008 Jul 9.
PubMed 18614345Tamaoki J, Kondo M, Sakai N, Nakata J, Takemura H, Nagai A, Takizawa T, Konno K. Leukotriene antagonist prevents exacerbation of asthma during reduction of high-dose inhaled corticosteroid. The Tokyo Joshi-Idai Asthma Research Group. Am J Respir Crit Care Med. 1997 Apr;155(4):1235-40. doi: 10.1164/ajrccm.155.4.9105060.
PubMed 9105060Morice AH, Fontana GA, Sovijarvi AR, Pistolesi M, Chung KF, Widdicombe J, O'Connell F, Geppetti P, Gronke L, De Jongste J, Belvisi M, Dicpinigaitis P, Fischer A, McGarvey L, Fokkens WJ, Kastelik J; ERS Task Force. The diagnosis and management of chronic cough. Eur Respir J. 2004 Sep;24(3):481-92. doi: 10.1183/09031936.04.00027804. No abstract available.
PubMed 15358710Gentile DA, Fireman P, Skoner DP. Elevations of local leukotriene C4 levels during viral upper respiratory tract infections. Ann Allergy Asthma Immunol. 2003 Sep;91(3):270-4. doi: 10.1016/S1081-1206(10)63529-6.
PubMed 14533659
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Concentration of Exhaled NO(FeNO) to Direct The Treatment of Sub-acute Cough：A Prospective, Open Label, Randomized and Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT02655562
- Acronym / sponsor ID
- Beijing Chao Yang Hospital
- Conditions
- Coughing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: There are difficulties in recruiting patients
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 14 Jan 2016 (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.
Cough is a common symptom that leads patients worldwide to seek medical attention. Subacute cough refers to a cough of 3-8-week duration, and is typically refractory to standard anti-tussive therapy, and a tendency to spontaneous healing was common. Few clinical trials have evaluated therapeutic options for subacute cough. Airway inflammation is an important feature of most of subacute cough, Cysteinyl leukotrienes and FeNO correlates with airway inflammation. Subacute cough often represents a prolonged post-viral response. Cysteinyl leukotrienes increase in virus infection. Airway inflammation induce epithelial cells produce iNOS(inducible nitric oxide synthase,iNOS), and FeNO increase in theory. Montelukast is a cysteinyl leukotriene type 1 receptor antagonist that is reported to improve cough16 and reduces FENO and prevents increases in FENO during reduction of inhaled corticosteroid dose, But A meta-analysis of the effectiveness of LTRA( leukotriene receptor antagonist,LTRA)in treating children with prolonged non-specific cough concluded that, with the lack of evidence, the routine use of LTRA in treating children with non-specific cough cannot be recommended. A randomised, placebo-controlled trial showed montelukast is not an effective treatment for postinfectious cough. Non-specialists or general practitioners of Japan prescribe LTRA very often, which increase. The aim is to research whether FeNO can be used as a biomarker to direct montelukast treatment and optimize treatment regimen of sub-acute cough.
Detailed description
This project is a prospective, open label, randomized and controlled trial. All subacute cough patients that met the inclusion/exclusion criteria were recruited after signing the consent form. Patients were randomized into biomarker treatment armand standard treatment arm.
Patients in biomarker treatment arm and FENO≥25ppb were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) . Patients in biomarker reatment arm and FENO<25ppb were given placebo (p.o., 10mg, qd). Patients in standard treatment arm and FENO≥25ppb were given placebo (p.o., 10mg, qd). Patients in standard treatment arm and FENO<25ppb were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) .All treatment regimens lasted for 10 days and no other antitussive/decongestant or bronchodilators are given to any patients.
Examine results of all patients from all arms were recorded before and after the 10 day treatment. The examine recorded are FENO levels, cough symptom assessment, cough visual assessment, Leicester cough questionnaire, total white blood cell count, neutrophil blood percentage, eosinophil blood percentage. Patient cough free days after treatment and Montelukast Sodium Tablets . Follow up was carried out at the 8th week after first record of symptom and 2 month after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biomarker treatment arm | Experimental | Drug: MontelukastPatients in biomarker treatment arm and FENO≥25ppb were given Montelukast Sodium Tablets (p.o., 10mg, qd) . Patients in biomarker reatment arm and FENO<25ppb were given placebo (p.o., 10mg, qd).All treatment regimens lasted for 10 days and no other antitussive/decongestant or bronchodilators are given to any patients. |
| standard treatment arm | Placebo comparator | Drug: MontelukastPatients in standard treatment arm and FENO≥25ppb were given placebo (p.o., 10mg, qd). Patients in standard treatment arm and FENO<25ppb were given Montelukast Sodium Tablets (p.o., 10mg, q.d.).All treatment regimens lasted for 10 days and no other antitussive/decongestant or bronchodilators are given to any patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cough is the main or only clinical symptom and was persistent for 3-8 weeks Chest X-ray reveals no noticeable pathological changes
- more than 18 year old, regardless of gender and ethical background
- Not taking angiotensin-converting enzyme inhibitor
- Patients must join the programme voluntarily and are able to attend examination and follow-up sessions
Key exclusion criteria (5 listed)
- Patients diagnosed with allergic rhinitis, chronic nasosinusitis or bacterial respiratory tract infections
- Patients diagnosed with severe reportorial disease of other severe systemic disease
- Patients who are allergic to any drugs to be tested
- Patients who are non-cooperative during examination sessions or other steps of the trial
- Patients who are not able to or refuse to sign consent
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 |
|---|---|---|
| MontelukastAlso: PlaceboPatients in biomarker treatment arm and FENO≥25ppb were given Montelukast Sodium Tablets (p.o., 10mg, qd) . Patients in biomarker reatment arm and FENO<25ppb were given placebo (p.o., 10mg, qd). Patients in standard treatment arm and FENO≥25ppb were given placebo (p.o., 10mg, qd). Patients in standard treatment arm and FENO<25ppb were given Montelukast Sodium Tablets (p.o., 10mg, q.d.).All treatment regimens lasted for 10 days and no other antitussive/decongestant or bronchodilators are given to any patients. | Drug | biomarker treatment arm, standard treatment arm |
Primary outcome
Leicester cough questionnaire
Time frame: 10 days
Change in Leicester Cough Questionnaire(LCQ) total and domain scores at 10 days post randomisation
1 secondary outcome
cough visual assessment
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Background: PubMed 11943681Wedde-Beer K, Hu C, Rodriguez MM, Piedimonte G. Leukotrienes mediate neurogenic inflammation in lungs of young rats infected with respiratory syncytial virus. Am J Physiol Lung Cell Mol Physiol. 2002 May;282(5):L1143-50. doi: 10.1152/ajplung.00323.2001.
- Background: PubMed 10200012van Schaik SM, Tristram DA, Nagpal IS, Hintz KM, Welliver RC 2nd, Welliver RC. Increased production of IFN-gamma and cysteinyl leukotrienes in virus-induced wheezing. J Allergy Clin Immunol. 1999 Apr;103(4):630-6. doi: 10.1016/s0091-6749(99)70235-6.
- Background: PubMed 15478381Spector SL, Tan RA. Effectiveness of montelukast in the treatment of cough variant asthma. Ann Allergy Asthma Immunol. 2004 Sep;93(3):232-6. doi: 10.1016/S1081-1206(10)61493-7.
- Background: PubMed 17928212Kato A, Schleimer RP. Beyond inflammation: airway epithelial cells are at the interface of innate and adaptive immunity. Curr Opin Immunol. 2007 Dec;19(6):711-20. doi: 10.1016/j.coi.2007.08.004. Epub 2007 Oct 24.
- Background: PubMed 24649919Mincheva RK, Kralimarkova TZ, Rasheva M, Dimitrov Z, Nedeva D, Staevska M, Papochieva V, Perenovska P, Bacheva K, Dimitrov VD, Popov TA. A real - life observational pilot study to evaluate the effects of two-week treatment with montelukast in patients with chronic cough. Cough. 2014 Mar 20;10(1):2. doi: 10.1186/1745-9974-10-2.
- Background: PubMed 12668799Birring SS, Prudon B, Carr AJ, Singh SJ, Morgan MD, Pavord ID. Development of a symptom specific health status measure for patients with chronic cough: Leicester Cough Questionnaire (LCQ). Thorax. 2003 Apr;58(4):339-43. doi: 10.1136/thorax.58.4.339.
- Background: PubMed 14555563Sandrini A, Ferreira IM, Gutierrez C, Jardim JR, Zamel N, Chapman KR. Effect of montelukast on exhaled nitric oxide and nonvolatile markers of inflammation in mild asthma. Chest. 2003 Oct;124(4):1334-40. doi: 10.1378/chest.124.4.1334.
- Background: PubMed 24461900Wang K, Birring SS, Taylor K, Fry NK, Hay AD, Moore M, Jin J, Perera R, Farmer A, Little P, Harrison TG, Mant D, Harnden A. Montelukast for postinfectious cough in adults: a double-blind randomised placebo-controlled trial. Lancet Respir Med. 2014 Jan;2(1):35-43. doi: 10.1016/S2213-2600(13)70245-5. Epub 2013 Dec 2.
- Results publication: PubMed 16685003Kwon NH, Oh MJ, Min TH, Lee BJ, Choi DC. Causes and clinical features of subacute cough. Chest. 2006 May;129(5):1142-7. doi: 10.1378/chest.129.5.1142.
- Results publication: PubMed 18460522Lim KG, Mottram C. The use of fraction of exhaled nitric oxide in pulmonary practice. Chest. 2008 May;133(5):1232-42. doi: 10.1378/chest.07-1712.
- Results publication: PubMed 7259071Tarnoky AL. Albumin. Ann Clin Biochem. 1981 Mar;18 (Pt 2):61-3. doi: 10.1177/000456328101800201. No abstract available.
- Results publication: PubMed 18614345Sato S, Saito J, Sato Y, Ishii T, Xintao W, Tanino Y, Ishida T, Munakata M. Clinical usefulness of fractional exhaled nitric oxide for diagnosing prolonged cough. Respir Med. 2008 Oct;102(10):1452-9. doi: 10.1016/j.rmed.2008.04.018. Epub 2008 Jul 9.
- Individual participant dataSharing planned: Undecided
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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.
Kewu Huang, M.D. study chair
Respiratory Medicine Department
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 in people with Coughing, run by Beijing Chao Yang Hospital 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 4 inclusion and 5 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: paused, as of the sponsor's last update on 22 Jul 2022. 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 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?
Results are not available in the source record.
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?
Leicester cough questionnaire (time frame: 10 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 NCT02655562, which also lists 18 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 22 Jul 2022.