Efficacy and Safety of add-on Montelukast to Inhaled Budesonide in the Treatment of Nonasthmatic Eosinophilic Bronchitis
NAEB
Randomized Double-blind Placebo-controlled Study of add-on Montelukast to Inhaled Budesonide in the Treatment of Nonasthmatic Eosinophilic Bronchitis
1 other identifier
interventional
63
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2010
CompletedFirst Posted
Study publicly available on registry
May 12, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedMay 12, 2010
September 1, 2009
1 year
May 11, 2010
May 11, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
cough severity rated as cough visual analogue score (VAS)
4 weeks
eosinophil count in induced sputum
4 weeks
Secondary Outcomes (1)
adverse reactions
4 weeks
Study Arms (2)
combination therapy
ACTIVE COMPARATORcombination therapy with inhaled budesonide and oral montelukast
monotherapy
PLACEBO COMPARATORmonotherapy with inhaled budesonide and placebo of montelukast
Interventions
same appearance, flavor, weight, and size to montelukast pills, 1 pill daily, for 4 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangzhou Institute of Respiratory Disease
Guangzhou, Guangdong, 510120, China
Related Publications (2)
Birring SS, Berry M, Brightling CE, Pavord ID. Eosinophilic bronchitis: clinical features, management and pathogenesis. Am J Respir Med. 2003;2(2):169-73. doi: 10.1007/BF03256647.
PMID: 14720015BACKGROUNDCai C, He MZ, Zhong SQ, Tang Y, Sun BQ, Chen QL, Zhong NS. Add-on montelukast vs double-dose budesonide in nonasthmatic eosinophilic bronchitis: a pilot study. Respir Med. 2012 Oct;106(10):1369-75. doi: 10.1016/j.rmed.2012.06.009. Epub 2012 Jul 21.
PMID: 22819521DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 11, 2010
First Posted
May 12, 2010
Study Start
June 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
May 12, 2010
Record last verified: 2009-09