The Utility of feNO in the Differential Diagnosis of Chronic Cough

NCT02479074 | Completed Phase 4 DMC

• 1 other identifier: AcadMed1002015
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cough

Keywords

Chronic

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days

Secondary Outcomes (6)

• HARQ and LCQ questionnaires

  28 days

• FVC as measured through spirometry

  28 days

• Cough Challenge

  28 days

• Sputum Induction

  28 days

• Blood Count

  Baseline

Study Arms (3)

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

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

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

Drug: Montelukast (Low FeNO group)

Interventions

Montelukast (High FeNO group) DRUG

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

Also known as: Montelukast

Montelukast (high FeNO)

Prednisolon, Montelukast (High FeNO) DRUG

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.

Also known as: Prednisolone and Montelukast

Prednisolone, Montelukast (high FeNO)

Montelukast (Low FeNO group) DRUG

Montelukast 10 mg film-coated tablet contains montelukast sodium equivalent to 10 mg montelukast patients to take one tablet per day for 28 days

Also known as: Montelukast

Montelukast

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead
• Aerocrine AB: collaborator

Study Sites (1)

Respiratory Medicine, Clinical trials Unit, Castle Hill Hospital

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 17381836 BACKGROUND

• Ford 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.

  PMID: 16809412 BACKGROUND

• Brightling 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.

  PMID: 10430705 BACKGROUND

• Korevaar 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.

  PMID: 25801413 BACKGROUND

• Sadeghi 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.

  PMID: 29177539 BACKGROUND

• Dicpinigaitis 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.

  PMID: 12095178 RESULT

• Sadeghi 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.

  PMID: 29508715 DERIVED

MeSH Terms

Conditions

Cough; Bronchiolitis Obliterans Syndrome

Interventions

montelukast; Prednisolone

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Alyn Morice, Professor

  Head of Centre for Cardiovascular and Metabolic Studies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 23, 2015
• Study Start: January 1, 2016
• Primary Completion: February 10, 2017
• Study Completion: March 9, 2017
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

GB (1)