Efficacy and Safety of add-on Montelukast to Inhaled Budesonide in the Treatment of Nonasthmatic Eosinophilic Bronchitis (NAEB)
Recruitment status was Not yet recruiting
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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 |
- 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 ]
- 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 |
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| Contact: Chuang Cai, Ph.D | 862083062844 | skinblack1966@yahoo.com.cn |
| China, Guangdong | |
| Guangzhou Institute of Respiratory Disease | Not yet recruiting |
| Guangzhou, Guangdong, China, 510120 | |
| Sub-Investigator: Nan-shan Zhong, bachelor | |
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 Acute Disease Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Disease Attributes Pathologic Processes Budesonide Montelukast Bronchodilator Agents Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents Leukotriene Antagonists Hormone Antagonists |
ClinicalTrials.gov processed this record on May 21, 2013