Nonasthmatic Eosinophilic BronchitisPhase 4NAEBNCT01121016
Efficacy and Safety of add-on Montelukast to Inhaled Budesonide in the Treatment of Nonasthmatic Eosinophilic Bronchitis
A Phase 4 study testing Montelukast in people with Nonasthmatic Eosinophilic Bronchitis, run by Guangzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nonasthmatic Eosinophilic Bronchitis
- What is being tested?
- Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- Jun 2010to Jun 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Institute of Respiratory Disease
Guangzhou, Guangdong, 510120
Nan-shan Zhong, bachelor
About this study
Official title: Randomized Double-blind Placebo-controlled Study of add-on Montelukast to Inhaled Budesonide in the Treatment of Nonasthmatic Eosinophilic Bronchitis
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.
Read the 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.
- Conditions
- Nonasthmatic Eosinophilic Bronchitis
- Being tested
- Montelukast, placebo to montelukast
- Keywords
- NAEB, chronic cough, montelukast, induced sputum
- Medical subject headings
- Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Also called Singulair
10mg, qn, 4 weeks
placebo to montelukastOther
same appearance, flavor, weight, and size to montelukast pills, 1 pill daily, for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| combination therapy | Active comparator | combination therapy with inhaled budesonide and oral montelukast Receives: Drug: Montelukast |
| monotherapy | Placebo comparator | monotherapy with inhaled budesonide and placebo of montelukast Receives: Other: placebo to montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
cough severity rated as cough visual analogue score (VAS)
Measured: 4 weeks
eosinophil count in induced sputum
Measured: 4 weeks
Secondary outcomes (1)
adverse reactions
any discomforts or untoward events observed during the study period
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nonasthmatic Eosinophilic BronchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Medical University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121016
- Sponsor's protocol ID
- moneb
- Acronym
- NAEB
- Status last verified
- Sep 2009
- First submitted
- 11 May 2010
- Last updated
- 12 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 14720015Cai 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.
PubMed 22819521
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Placebo-controlled Study of add-on Montelukast to Inhaled Budesonide in the Treatment of Nonasthmatic Eosinophilic Bronchitis
- ClinicalTrials.gov ID
- NCT01121016
- Acronym / sponsor ID
- NAEB / moneb
- Conditions
- Nonasthmatic Eosinophilic Bronchitis
- Keywords
- NAEB, chronic cough, montelukast, induced sputum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 12 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination therapy | Active comparator | Drug: Montelukastcombination therapy with inhaled budesonide and oral montelukast |
| monotherapy | Placebo comparator | Other: placebo to montelukastmonotherapy with inhaled budesonide and placebo of montelukast |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MontelukastAlso: Singulair10mg, qn, 4 weeks | Drug | combination therapy |
| placebo to montelukastsame appearance, flavor, weight, and size to montelukast pills, 1 pill daily, for 4 weeks | Other | monotherapy |
Primary outcome
cough severity rated as cough visual analogue score (VAS)
Time frame: 4 weeks
eosinophil count in induced sputum
Time frame: 4 weeks
1 secondary outcome
adverse reactions
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2010.
- Background: PubMed 14720015Birring 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.
- Derived from this study: PubMed 22819521Cai 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Montelukast in people with Nonasthmatic Eosinophilic Bronchitis, run by Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuang Cai, Ph.D (862083062844, skinblack1966@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cough severity rated as cough visual analogue score (VAS) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01121016, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2010.