Efficacy and Safety of add-on Montelukast to Inhaled Budesonide in the Treatment of Nonasthmatic Eosinophilic Bronchitis | RxWiki

Efficacy and Safety of add-on Montelukast to Inhaled Budesonide in the Treatment of Nonasthmatic Eosinophilic Bronchitis

Overview[ - collapse ][ - ]

Purpose	Hypothesis: Add-on therapy with oral montelukast (Mon) to inhaled budesonide (BUD) may achieve better control of cough caused by nonasthmatic eosinophilic bronchitis (NAEB) with faster reduction of airway eosinophilia. Objective: To evaluate the efficacy of add-on therapy with Mon to inhaled corticosteroids (ICS) in the treatment of adult patients with chronic/subacute cough caused by NAEB diagnosed in outpatient setting. Primary endpoint：cough severity rated as cough visual analogue score (VAS)1 and eosinophil count in induced sputum during 4-week BUD monotherapy or Mon adjunct therapy.
Condition	Nonasthmatic Eosinophilic Bronchitis
Intervention	Drug: Montelukast Other: placebo to montelukast
Phase	Phase 4
Sponsor	Guangzhou Medical University
Responsible Party	Guangzhou Medical University
ClinicalTrials.gov Identifier	NCT01121016
First Received	May 11, 2010
Last Updated	May 11, 2010
Last verified	September 2009

Tracking Information[ + expand ][ + ]

First Received Date	May 11, 2010
Last Updated Date	May 11, 2010
Start Date	June 2010
Estimated Primary Completion Date	June 2011
Current Primary Outcome Measures	cough severity rated as cough visual analogue score (VAS) [Time Frame: 4 weeks] [Designated as safety issue: No] eosinophil count in induced sputum [Time Frame: 4 weeks] [Designated as safety issue: No]
Current Secondary Outcome Measures	adverse reactions [Time Frame: 4 weeks] [Designated as safety issue: Yes]any discomforts or untoward events observed during the study period

Descriptive Information[ + expand ][ + ]

Brief Title	Efficacy and Safety of add-on Montelukast to Inhaled Budesonide in the Treatment of Nonasthmatic Eosinophilic Bronchitis
Official Title	Randomized Double-blind Placebo-controlled Study of add-on Montelukast to Inhaled Budesonide in the Treatment of Nonasthmatic Eosinophilic Bronchitis
Brief Summary	Hypothesis: Add-on therapy with oral montelukast (Mon) to inhaled budesonide (BUD) may achieve better control of cough caused by nonasthmatic eosinophilic bronchitis (NAEB) with faster reduction of airway eosinophilia. Objective: To evaluate the efficacy of add-on therapy with Mon to inhaled corticosteroids (ICS) in the treatment of adult patients with chronic/subacute cough caused by NAEB diagnosed in outpatient setting. Primary endpoint：cough severity rated as cough visual analogue score (VAS)1 and eosinophil count in induced sputum during 4-week BUD monotherapy or Mon adjunct therapy.
Detailed Description	Subjects：63 newly-diagnosed, steroid-naïve adult patients with chronic or subacute cough caused by NAEB. Grouping：ICS monotherapy (21 patients, BUD，400mcg mcg, twice daily+ placebo, 4 wks); Mon adjunct therapy (42 patients, Mon 10mg once daily + BUD 400mcg twice daily 4wks). Protocol Day 1: In the respiratory specialist clinic, the diagnosis of NAEB is established following the 2006 ACCP guideline (sputum eosinophilia >3%, negative chest radiography, spirometry and bronchial provocation test). After briefing, eligible subjects who have given informed written consents, are to be randomly allocated to different treatment groups. Patients' demographical data, course and nature of cough, accompanying symptoms and upper respiratory comorbidities, skin prick test to common aeroallergens1, baseline cough VAS (0-100 mm) 1, spirometry and induced sputum cell counts, will be recorded by the managing physician in case record file (CRF). Pulmicort Turbuhaler (AstraZeneca, budesonide 100 mcg/dose X 200 doses) will be prescribed to each patient. Day 2: Before initiation of treatment, at the Office for Clinical Trials, staff members will instruct the patients on correct usage of ICS, disperse Mon tablets or placebo as well as daily record cards, and explain how to record daily use of ICS and Mon, and adverse events. Once the treatment is initiated, oral steroids, other ICS, anti-histamines, beta-2 agonists and theophyllines will not be prescribed and used throughout the study period. Day 8、15：Revisits: Patients' nature of cough, accompanying symptoms, cough VAS, induced sputum cell count will be reevaluated and recorded in CRF. Old daily record cards will be collected. New ones as well as Mon tablets or placebo will be given. Patients' skill of using ICS, compliance, systemic or local adverse events will be monitored. Day 29： Revisit: Patients' nature of cough, accompanying symptoms, cough VAS, spirometry, bronchial provocation test, induced sputum cell count will be reevaluated and recorded in CRF. Old daily record cards will be collected. Patients' skill of using ICS, compliance, systemic or local adverse events will be recorded.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Condition	Nonasthmatic Eosinophilic Bronchitis
Intervention	Drug: Montelukast 10mg, qn, 4 weeks Other Names: SingulairOther: placebo to montelukast same appearance, flavor, weight, and size to montelukast pills, 1 pill daily, for 4 weeks
Study Arm (s)	Active Comparator: combination therapy combination therapy with inhaled budesonide and oral montelukast Placebo Comparator: monotherapy monotherapy with inhaled budesonide and placebo of montelukast

Recruitment Information[ + expand ][ + ]

Recruitment Status	Not yet recruiting
Estimated Enrollment	63
Estimated Completion Date	June 2011
Estimated Primary Completion Date	June 2011
Eligibility Criteria	Inclusion Criteria: - Adult nonsmoking NAEB patients - Without history of taking Mon, oral or inhaled corticosteroids, and - Without bacterial or viral respiratory infections within 30 days prior to diagnosis of NAEB Exclusion Criteria: - Current smokers - Pregnant or lactating women - Known allergy to Mon, oral or inhaled corticosteroids - Unable to use ICS following repeated instructions - Complicated with unresectable malignancy or severe heart, lung, liver or kidney diseases
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Chuang Cai, Ph.D 862083062844 skinblack1966@yahoo.com.cn
Location Countries	China

Administrative Information[ + expand ][ + ]

NCT Number	NCT01121016
Other Study ID Numbers	moneb
Has Data Monitoring Committee	Yes
Information Provided By	Guangzhou Medical University
Study Sponsor	Guangzhou Medical University
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	September 2009

Locations[ + expand ][ + ]