CoughingNCT02303600
Fractional Concentration of Exhaled NO(FENO) to Direct Montelukast Treatment of Sub-acute Cough
A 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 of respiratory medicine clinic patients, which has complex etiology and wide-ranging. Cough is usually divided into three categories by time: acute cough, subacute cough and chronic cough. Subacute has a 3~8 weeks course of disease. 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
- Aug 2014to Aug 2015
- Phase
- Interventional
- 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
- ≥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 rhinallergosis, 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.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality
Kewu Huang, M.D., 86-10-85231167, kewuhuang@126.com
Min Liu, Master, 86-0-13522226189, stream_1980@163.com
About this study
Official title: Fractional Concentration of Exhaled NO(FENO) to Direct Montelukast Treatment of Sub-acute Cough:A Prospective, Open Label, Randomized and Placebo-Controlled Trial
Cough is a common symptom of respiratory medicine clinic patients, which has complex etiology and wide-ranging. Cough is usually divided into three categories by time: acute cough, subacute cough and chronic cough. Subacute has a 3~8 weeks course of disease. Its main etiology is postinfectious cough, which is mostly secondary to viral infection.Considering its overexpression in postinfectious patient, Cysteinyl leukotriene (CysLTs) plays a role in gathering eosinophils to respiratory. The level of FENO has a significant correlation with inflammatory airway eosinophils. While CysLTs overexpressed in vivo, the level of FENO may increase. Montelukast, as CysLTs-receptor-1 antagonists， plays a role of controlling airway inflammation and decrease airway high activity by suppressing the biological activity of CysLTs. It is effective in theory to therapy sub-acute cough by Montelukast, to short the course and to relieve cough symptoms as soon as possible. The aim is to research whether FENO can be used as a biomarker to optimized 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 arm and standard treatment arm. Positive or negative biomarker expression was confirmed by assessing fractional concentration of exhaled NO (FENO) level, FENO<25ppb was regarded as negative and FENO≥25ppb was regarded as positive.
Patients in biomarker guided positive treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) . Patients in biomarker guided negative treatment arm were given placebo tablets(p.o., 10mg, q.d.). Patients in standard treatment arm 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, Placebo
- Keywords
- Sub-acute cough
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Patients in biomarker guided positive treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.). Patients in biomarker guided negative treatment arm were given placebo tablets . Patients in standard treatment arm 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.
PlaceboOther
Also called Placebo (main excipient lactose monohydrate)
Patients in biomarker guided negative treatment arm were given placebo tablets (main excipient lactose monohydrate) (p.o., 10mg, q.d.) .
| Study group | Role | What they receive |
|---|---|---|
| biomarker treatment arm | Experimental | Patients in biomarker guided positive treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) . Patients in biomarker guided negative treatment arm were given placebo tablets (main excipient lactose monohydrate). Receives: Other: Placebo |
| standard treatment arm | Active comparator | Patients in standard treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) . Receives: Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leicester cough questionnaire
Measured: 10 days
Secondary outcomes (1)
cough visual assessment
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 posted1 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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 N/A
- 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, Min Liu, Beijing Chao Yang Hospital
- Investigators
- Kewu Huang, M.D., Study chair, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303600
- Sponsor's protocol ID
- SAC2014
- Status last verified
- Nov 2014
- First submitted
- 17 Nov 2014
- Last updated
- 1 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Morice 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 15358710Kwon 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 18460522McCool FD. Global physiology and pathophysiology of cough: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):48S-53S. doi: 10.1378/chest.129.1_suppl.48S.
PubMed 16428691Mita H, Turikisawa N, Yamada T, Taniguchi M. Quantification of leukotriene B4 glucuronide in human urine. Prostaglandins Other Lipid Mediat. 2007 Feb;83(1-2):42-9. doi: 10.1016/j.prostaglandins.2006.09.010. Epub 2006 Dec 5.
PubMed 17259071Ryan NM, Gibson PG. Extrathoracic airway hyperresponsiveness as a mechanism of post infectious cough: case report. Cough. 2008 Aug 4;4:7. doi: 10.1186/1745-9974-4-7.
PubMed 18673583Cho YS, Park SY, Lee CK, Lee EY, Shin JH, Yoo B, Moon HB. Enhanced cough response to hyperpnea with cold air challenge in chronic cough patients showing increased cough sensitivity to inhaled capsaicin. Allergy. 2003 Jun;58(6):486-91. doi: 10.1034/j.1398-9995.2003.00183.x.
PubMed 12757448Montuschi P, Mondino C, Koch P, Barnes PJ, Ciabattoni G. Effects of a leukotriene receptor antagonist on exhaled leukotriene E4 and prostanoids in children with asthma. J Allergy Clin Immunol. 2006 Aug;118(2):347-53. doi: 10.1016/j.jaci.2006.04.010. Epub 2006 Jul 3.
PubMed 16890757Kato 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 17928212Sato 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 18614345Seymour ML, Gilby N, Bardin PG, Fraenkel DJ, Sanderson G, Penrose JF, Holgate ST, Johnston SL, Sampson AP. Rhinovirus infection increases 5-lipoxygenase and cyclooxygenase-2 in bronchial biopsy specimens from nonatopic subjects. J Infect Dis. 2002 Feb 15;185(4):540-4. doi: 10.1086/338570. Epub 2002 Jan 31.
PubMed 11865407Gentile 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 14533659van 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 10200012Kim CK, Koh JY, Han TH, Kim DK, Kim BI, Koh YY. Increased levels of BAL cysteinyl leukotrienesinacute [corrected] RSV bronchiolitis. Acta Paediatr. 2006 Apr;95(4):479-85. doi: 10.1080/08035250600554268.
PubMed 16720498Payne DN, Adcock IM, Wilson NM, Oates T, Scallan M, Bush A. Relationship between exhaled nitric oxide and mucosal eosinophilic inflammation in children with difficult asthma, after treatment with oral prednisolone. Am J Respir Crit Care Med. 2001 Oct 15;164(8 Pt 1):1376-81. doi: 10.1164/ajrccm.164.8.2101145.
PubMed 11704581
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Concentration of Exhaled NO(FENO) to Direct Montelukast Treatment of Sub-acute Cough:A Prospective, Open Label, Randomized and Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT02303600
- Acronym / sponsor ID
- SAC2014
- Conditions
- Coughing
- Keywords
- Sub-acute cough
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 1 Dec 2014 (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 of respiratory medicine clinic patients, which has complex etiology and wide-ranging. Cough is usually divided into three categories by time: acute cough, subacute cough and chronic cough. Subacute has a 3~8 weeks course of disease. Its main etiology is postinfectious cough, which is mostly secondary to viral infection.Considering its overexpression in postinfectious patient, Cysteinyl leukotriene (CysLTs) plays a role in gathering eosinophils to respiratory. The level of FENO has a significant correlation with inflammatory airway eosinophils. While CysLTs overexpressed in vivo, the level of FENO may increase. Montelukast, as CysLTs-receptor-1 antagonists， plays a role of controlling airway inflammation and decrease airway high activity by suppressing the biological activity of CysLTs. It is effective in theory to therapy sub-acute cough by Montelukast, to short the course and to relieve cough symptoms as soon as possible. The aim is to research whether FENO can be used as a biomarker to optimized 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 arm and standard treatment arm. Positive or negative biomarker expression was confirmed by assessing fractional concentration of exhaled NO (FENO) level, FENO<25ppb was regarded as negative and FENO≥25ppb was regarded as positive.
Patients in biomarker guided positive treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) . Patients in biomarker guided negative treatment arm were given placebo tablets(p.o., 10mg, q.d.). Patients in standard treatment arm 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 | Other: PlaceboPatients in biomarker guided positive treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) . Patients in biomarker guided negative treatment arm were given placebo tablets (main excipient lactose monohydrate). |
| standard treatment arm | Active comparator | Drug: MontelukastPatients in standard treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cough is the main or only clinical symptom and was persistent for 3-8 weeks
- Chest X-ray reveals no noticeable pathological changes
- ≥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 rhinallergosis, 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 |
|---|---|---|
| MontelukastPatients in biomarker guided positive treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.). Patients in biomarker guided negative treatment arm were given placebo tablets . Patients in standard treatment arm 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 | standard treatment arm |
| PlaceboAlso: Placebo (main excipient lactose monohydrate)Patients in biomarker guided negative treatment arm were given placebo tablets (main excipient lactose monohydrate) (p.o., 10mg, q.d.) . | Other | biomarker treatment arm |
Primary outcome
Leicester cough questionnaire
Time frame: 10 days
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 1 Dec 2014.
- Background: PubMed 15358710Morice 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.
- Background: 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.
- Background: 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.
- Background: PubMed 16428691McCool FD. Global physiology and pathophysiology of cough: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):48S-53S. doi: 10.1378/chest.129.1_suppl.48S.
- Background: PubMed 17259071Mita H, Turikisawa N, Yamada T, Taniguchi M. Quantification of leukotriene B4 glucuronide in human urine. Prostaglandins Other Lipid Mediat. 2007 Feb;83(1-2):42-9. doi: 10.1016/j.prostaglandins.2006.09.010. Epub 2006 Dec 5.
- Background: PubMed 18673583Ryan NM, Gibson PG. Extrathoracic airway hyperresponsiveness as a mechanism of post infectious cough: case report. Cough. 2008 Aug 4;4:7. doi: 10.1186/1745-9974-4-7.
- Background: PubMed 12757448Cho YS, Park SY, Lee CK, Lee EY, Shin JH, Yoo B, Moon HB. Enhanced cough response to hyperpnea with cold air challenge in chronic cough patients showing increased cough sensitivity to inhaled capsaicin. Allergy. 2003 Jun;58(6):486-91. doi: 10.1034/j.1398-9995.2003.00183.x.
- Background: PubMed 16890757Montuschi P, Mondino C, Koch P, Barnes PJ, Ciabattoni G. Effects of a leukotriene receptor antagonist on exhaled leukotriene E4 and prostanoids in children with asthma. J Allergy Clin Immunol. 2006 Aug;118(2):347-53. doi: 10.1016/j.jaci.2006.04.010. Epub 2006 Jul 3.
- 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 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.
- Background: PubMed 11865407Seymour ML, Gilby N, Bardin PG, Fraenkel DJ, Sanderson G, Penrose JF, Holgate ST, Johnston SL, Sampson AP. Rhinovirus infection increases 5-lipoxygenase and cyclooxygenase-2 in bronchial biopsy specimens from nonatopic subjects. J Infect Dis. 2002 Feb 15;185(4):540-4. doi: 10.1086/338570. Epub 2002 Jan 31.
- Background: PubMed 14533659Gentile 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.
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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
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A 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 5 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: status not confirmed, as of the sponsor's last update on 1 Dec 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Kewu Huang, M.D. (86-10-85231167, kewuhuang@126.com), or a site near the patient. 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 NCT02303600, which also lists 16 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 1 Dec 2014.