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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Guangzhou Medical University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT01121016
First received: May 11, 2010
Last updated: NA
Last verified: September 2009
History: No changes posted
  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 Intervention Phase
Nonasthmatic Eosinophilic Bronchitis
Drug: Montelukast
Other: placebo to montelukast
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Guangzhou Medical University:

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 ]

Secondary Outcome Measures:
  • adverse reactions [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    any discomforts or untoward events observed during the study period


Estimated Enrollment: 63
Study Start Date: June 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: May 11, 2010
Last Updated: May 11, 2010
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Budesonide
Montelukast
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on September 16, 2014