Open-label Study of the Effects of Montelukast in Patients With Chronic Cough

NCT01754220 | Completed Phase 4 DMC

• 1 other identifier: ALKA-03-12
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Montelukast, a leukotriene receptor antagonist, is likely to be effective in the treatment of chronic cough and this could be made objective by measuring cough threshold before and after two weeks of treatment.

Conditions

Coughing

Outcome Measures

Primary Outcomes (2)

• Difference in the cough reflex parameters (C2 and C5) before and after two weeks of treatment with montelukast

  7 months

• Difference in average scores on modified Leicester Cough Questionnaire (LCQ) before and after two weeks of treatment with montelukast

  7 months

Secondary Outcomes (3)

• Difference in pulmonary function parameters (FVC, FEV1, PEF), before and after two weeks of treatment with montelukast

  7 months

• Difference in Exhaled breath temperature (EBT) before and after two weeks of treatment with montelukast

  7 months

• Difference in laboratory markers (CBC, CRP, total IgE, ESP, MPO) before and after two weeks of treatment with montelukast

  7 months

Study Arms (1)

Montelukast

ACTIVE COMPARATOR

Montelukast tablets: adults - 10 mg, children - 5mg taken daily for two weeks

Drug: Montelukast

Interventions

Montelukast DRUG

Montelukast is a leukotriene receptor antagonist

Also known as: Alvokast

Montelukast

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with chronic cough: cough persisting for more than 8 consecutive weeks

You may not qualify if:

• Current use of ACE-inhibitors
• Use of systemic steroids in the last 4 weeks
• COPD
• Pregnancy
• Concomitant severe disease
• Smoking

Sponsors & Collaborators

• Association Asthma, Bulgaria: lead

Study Sites (1)

Clinic of Allergy and Asthma, University Hospital "Alexandrovska"

Sofia, Sofia, 1431, Bulgaria

Location

Related Publications (3)

• Palombini BC, Villanova CA, Araujo E, Gastal OL, Alt DC, Stolz DP, Palombini CO. A pathogenic triad in chronic cough: asthma, postnasal drip syndrome, and gastroesophageal reflux disease. Chest. 1999 Aug;116(2):279-84. doi: 10.1378/chest.116.2.279.

  PMID: 10453852 BACKGROUND

• Paredi P, Caramori G, Cramer D, Ward S, Ciaccia A, Papi A, Kharitonov SA, Barnes PJ. Slower rise of exhaled breath temperature in chronic obstructive pulmonary disease. Eur Respir J. 2003 Mar;21(3):439-43. doi: 10.1183/09031936.03.00061902.

  PMID: 12661998 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 DERIVED

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

• Todor A Popov, MD, Phd

  Association Asthma, Bulgaria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2012
• First Posted: December 21, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 21, 2012

Record last verified: 2012-12

Locations

BU (1)