Fractional Concentration of Exhaled NO(FeNO) to Direct The Treatment of Sub-acute Cough

NCT02655562 | Suspended Phase 4 DMC

• 1 other identifier: Beijing Chao Yang Hospital
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Coughing

Outcome Measures

Primary Outcomes (1)

• Leicester cough questionnaire

  Change in Leicester Cough Questionnaire(LCQ) total and domain scores at 10 days post randomisation

  10 days

Secondary Outcomes (1)

• cough visual assessment

  10 days

Study Arms (2)

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.

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.

Drug: Montelukast

Interventions

Montelukast DRUG

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.

Also known as: Placebo

biomarker treatment arm; standard treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Mingming Jiang

Beijing, China

Location

Related Publications (18)

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  PMID: 11943681 BACKGROUND

• van 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.

  PMID: 10200012 BACKGROUND

• Spector 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.

  PMID: 15478381 BACKGROUND

• Kato 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.

  PMID: 17928212 BACKGROUND

• Mincheva 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.

  PMID: 24649919 BACKGROUND

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  PMID: 12668799 BACKGROUND

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  PMID: 14555563 BACKGROUND

• Wang 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.

  PMID: 24461900 BACKGROUND

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  PMID: 16685003 RESULT

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  PMID: 18460522 RESULT

• Tarnoky AL. Albumin. Ann Clin Biochem. 1981 Mar;18 (Pt 2):61-3. doi: 10.1177/000456328101800201. No abstract available.

  PMID: 7259071 RESULT

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  PMID: 18614345 RESULT

• Tamaoki 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.

  PMID: 9105060 RESULT

• 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.

  PMID: 15358710 RESULT

• Gentile 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.

  PMID: 14533659 RESULT

• Grant CC. Postinfectious cough and pertussis in primary care. Lancet Respir Med. 2014 Jan;2(1):2-3. doi: 10.1016/S2213-2600(13)70260-1. Epub 2013 Dec 2. No abstract available.

  PMID: 24461880 RESULT

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  PMID: 21198555 RESULT

MeSH Terms

Conditions

Cough

Interventions

montelukast

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kewu Huang, M.D.

  Respiratory Medicine Department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 30, 2015
• First Posted: January 14, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2026
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

CN (1)