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

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ClinicalTrials.gov Identifier: NCT01121016
Recruitment Status : Unknown
Verified September 2009 by Guangzhou Medical University.
Recruitment status was:  Not yet recruiting
First Posted : May 12, 2010
Last Update Posted : May 12, 2010
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Nonasthmatic Eosinophilic Bronchitis Drug: Montelukast Other: placebo to montelukast Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Double-blind Placebo-controlled Study of add-on Montelukast to Inhaled Budesonide in the Treatment of Nonasthmatic Eosinophilic Bronchitis
Study Start Date : June 2010
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: combination therapy
combination therapy with inhaled budesonide and oral montelukast
Drug: Montelukast
10mg, qn, 4 weeks
Other Name: Singulair
Placebo Comparator: monotherapy
monotherapy with inhaled budesonide and placebo of montelukast
Other: placebo to montelukast
same appearance, flavor, weight, and size to montelukast pills, 1 pill daily, for 4 weeks


Outcome Measures

Primary Outcome Measures :
  1. cough severity rated as cough visual analogue score (VAS) [ Time Frame: 4 weeks ]
  2. eosinophil count in induced sputum [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. adverse reactions [ Time Frame: 4 weeks ]
    any discomforts or untoward events observed during the study period


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01121016


Contacts
Contact: Chuang Cai, Ph.D 862083062844 skinblack1966@yahoo.com.cn

Locations
China, Guangdong
Guangzhou Institute of Respiratory Disease Not yet recruiting
Guangzhou, Guangdong, China, 510120
Sub-Investigator: Nan-shan Zhong, bachelor         
Sponsors and Collaborators
Guangzhou Medical University
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chuang Cai/ Associate Professor, Guangzhou Institute of Respiratory Medicine
ClinicalTrials.gov Identifier: NCT01121016     History of Changes
Other Study ID Numbers: moneb
First Posted: May 12, 2010    Key Record Dates
Last Update Posted: May 12, 2010
Last Verified: September 2009

Keywords provided by Guangzhou Medical University:
NAEB, chronic cough, montelukast, induced sputum

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Budesonide
Montelukast
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Hormone Antagonists
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action