AsthmaPhase 4NCT01404013
Effects of Leukotriene Modulator Montelukast on Cough Variant Asthma
A Phase 4 study testing ICS/LABA, Montelukast and ICS/LABA and Montelukast in people with Asthma, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This study aims to observe the therapeutic effect of leukotriene modulator montelukast alone or combined with inhaled corticosteroid(ICS) on cough variant asthma(CVA). The investigators hypothesize: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- ICS/LABA, Montelukast and ICS/LABA and Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to Aug 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have a history of cough as sole or main symptom lasting more than 8 weeks, often irritating cough more cough at night.
- Patients who were diagnosed with positive result in bronchial provocation test by methacholine inhalation challenge.
- There is evidence that bronchodilator treatment* is efficient for cough symptom (symptom score improved 1 at least).
- Patients whose chest x-ray outcome was normal or without any active focus.
- Patients who was aged from 18 years old (≥ 18 years old ) to 75 years old (≤ 75 years old).
Who cannot join
- Patients demonstrate FEV1/FVC <70% in lung function test. FEV1 stands for forced expiratory volume in 1 second, FVC stands for forced vital capacity.
- Patients who is a smoker or ex-smoker and has smoked within the previous year or has a cumulative smoking history >10 pack-years or equivalence.
- Patients with concomitance of GERC (gastroesophageal reflux-related chronic cough), chronic bronchitis , bronchiectasis, bronchial tuberculosis, ACEI induced cough, bronchogenic carcinoma, psychologic cough, pulmonary fibrosis, bronchus foreign body, microlithiasis, tracheobroncheopathia osteochondroplastica, mediastinal tumor, left ventricular dysfunction.
- Female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study.
- Subjects who are known or suspected to be hypersensitive to any component of the study medication or relief medications.
- Subjects who have received any therapy in the previous seven days, e.g. oral/ inhaled/systematic corticosteroid, long-acting β2 agonist, theophylline sustained release.
- Subjects who are diagnosed with past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease. e.g.nasal-sinus infection, lower respiratory tract infection, chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis or bronchopulmonary dysplasia.
- Subjects who demonstrate significant abnormality on biochemistry, hematology, ECG.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Institute of Respiratory Disease
Guangzhou, Guangdong, 520120
Kefang Lai, PHD, klai@163.com
Kefang Lai, PHD
About this study
Official title: Randomised, Open-label, Parallel-group Study of Therapeutic Effect of Leukotriene Modulator Montelukast Alone or Combined With Inhaled Corticosteroid on Cough Variant Asthma
This study aims to observe the therapeutic effect of leukotriene modulator montelukast alone or combined with inhaled corticosteroid(ICS) on cough variant asthma(CVA).
The investigators hypothesize:
- Cough score and cough reflex sensitivity will be improved after treatment with montelukast, inhaled corticosteroid/β2 agonist(ICS/LABA), and two combinations.
- Combination of leukotriene modulator and inhaled corticosteroid/β2 agonist may have better efficacy when compared to montelukast, corticosteroid/β2 agonist alone while MON, is comparable to symbicort.
Read the detailed description
Study groups:
99 patients diagnosed with CVA will be randomised into three groups as follows:
Group 1: inhaled corticosteroid+β2 agonist The patients with cough variant asthma received Symbicort Turbuhaler (Budesonide 160µg and Formoterol 4.5µg) 1puff Q12h for 8 weeks.
Group 2: montelukast The patients with cough variant asthma received montelukast 10mg QN for 8 weeks, without any other corticosteroid or β2 agonist.
Group 3: montelukast combined with inhaled corticosteroid+β2 agonist The patients with cough variant asthma received montelukast 10mg QN combined with Symbicort Turbuhaler (Budesonide 160µg and Formoterol 4.5µg) 1puff Q12h for 8 weeks..
The study will be divided into following phases:
- First Visit (Visit 1, day -6): A full medical history and physical examination to be undertaken to determine whether patients meet the inclusion/exclusion criteria. After the informed consent has been signed, the following samples are obtained from all patients: blood samples for routine clinical laboratory tests (haematology, biochemistry and chest x-ray). A urine pregnancy test will be performed in women of childbearing potential. Bronchial provocation test by methacholine inhalation are performed to determined the presence of bronchial non-specific hyper-responsiveness. Patients are given the Diary Card.
- Screening Period ( day -6 to day 0, 6 Days) Patients took two medications as bellows for 3 days and followed by 3 days of wash-out period. Patients should completed 6 days diary card, starting from day -6 to week 0. Bambuterol HCI (Bambec, brand name), 10 mg qn po Theophylline tablet sustained release, 100mg bid po
- Second Visit (Visit 2, Week 0): A physical examination were to be performed. All laboratory tests results are obtained to determine whether patients meet the inclusion/exclusion criteria. Concurrent medication were recorded. The Diary Card were collected, reviewed and assessed whether ICS, bronchodilator or ICS/BD treatment is efficient for cough symptom (symptom score improved 1 at least). Capsaicin challenge test and FENO were performed and hypertonic saline induced sputum samples for cell differential, urine leukotriene, serum IgE, were taken from enrolled patients. Enrolled patients were randomized into different groups, and the study medication were dispensed.
- During Treatment 1(Week 0 to Week 4, 14 days): Patients were to take study medication for 28 days and completed Diary Card for 7 days from Week 3 to Week 4.
- Third Visit (Visit 3, Week 4): A physical examination were to be performed. The Diary Card were collected and reviewed. Adverse events, secondary complications, concurrent medication will be recorded. Capsaicin challenge test and FENO were performed and hypertonic saline induced sputum samples for cell differential were taken from enrolled patients.
- During Treatment 2 (Week 4 to Week 8, 14 days): Patients were to take study medication for 28 days and completed Diary Card for 7 days from Week 7 to Week 8.
- Forth Visit (Visit 4, Week 8):
A physical examination and were to be performed. The Diary Card were collected and reviewed. Residual (unused) medications were to be returned. Adverse events, secondary complications, concurrent medication will be recorded.
Capsaicin challenge test and FENO were performed and hypertonic saline induced sputum samples for cell differential, urine leukotriene, serum IgE, were taken from enrolled patients.
Blood samples for routine clinical laboratory tests (haematology and biochemistry) were obtained, if a clinically significant laboratory abnormal result was noted at the visit 4, AE and a follow-up visit would be considered.
- Conditions
- Asthma
- Being tested
- ICS/LABA, Montelukast, ICS/LABA and Montelukast
- Keywords
- Montelukast, Cough variant asthma, Inhaled Corticosteroid
- Medical subject headings
- Asthma, Cough-Variant Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICS/LABADrug
Also called Symbicort Turbuhaler
Budesonide 160µg and Formoterol 4.5µg, 1puff ,twice a day, for 8 weeks
MontelukastDrug
Also called Singulair
Montelukast 10mg ,every night, for 8 weeks
ICS/LABA and MontelukastDrug
Also called Inhaled corticosteroid/β2 agonist: Symbicort Turbuhaler, Montelukast: Singulair
Budesonide 160µg and Formoterol 4.5µg, 1puff, twice a day, for 8 weeks; Montelukast 10mg ,take orally ,every night for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Montelukast | Active comparator | Monotherapy with Montelukast 10mg, take orally ,every night,for 8 weeks Receives: Drug: Montelukast |
| ICS/LABA and Montelukast | Active comparator | Combination therapy with inhaled corticosteroid/β2 agonist 160/4.5ug,twice a day and Montelukast 10mg，take orally,every night for 8 weeks Receives: Drug: ICS/LABA and Montelukast |
| ICS/LABA | Active comparator | Monotherapy with corticosteroid/β2 agonist 160/4.5ug,inhaled, twice a day, for 8 weeks Receives: Drug: ICS/LABA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day-time and night-time cough symptom total-score changes from baseline to visit 4
Measured: 8 weeks
Secondary outcomes (1)
Cough reflex sensitivity changes in different groups at baseline, visit 2, visit3, and visit 4. Cell differential changes in hypertonic saline induced sputum in different groups at baseline, visit 2, visit3, and visit 4.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startFeb 2012
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Mengfeng Li, MD., Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404013
- Sponsor's protocol ID
- MISP 39227
- Status last verified
- Nov 2012
- First submitted
- 26 Jul 2011
- Last updated
- 14 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yi F, Zhan C, Liu B, Li H, Zhou J, Tang J, Peng W, Luo W, Chen Q, Lai K. Effects of treatment with montelukast alone, budesonide/formoterol alone and a combination of both in cough variant asthma. Respir Res. 2022 Oct 10;23(1):279. doi: 10.1186/s12931-022-02114-6.
PubMed 36217131
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Open-label, Parallel-group Study of Therapeutic Effect of Leukotriene Modulator Montelukast Alone or Combined With Inhaled Corticosteroid on Cough Variant Asthma
- ClinicalTrials.gov ID
- NCT01404013
- Acronym / sponsor ID
- MISP 39227
- Conditions
- Asthma
- Keywords
- Montelukast, Cough variant asthma, Inhaled Corticosteroid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Feb 2012
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 27 Jul 2011 (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.
This study aims to observe the therapeutic effect of leukotriene modulator montelukast alone or combined with inhaled corticosteroid(ICS) on cough variant asthma(CVA).
The investigators hypothesize:
- Cough score and cough reflex sensitivity will be improved after treatment with montelukast, inhaled corticosteroid/β2 agonist(ICS/LABA), and two combinations.
- Combination of leukotriene modulator and inhaled corticosteroid/β2 agonist may have better efficacy when compared to montelukast, corticosteroid/β2 agonist alone while MON, is comparable to symbicort.
Detailed description
Study groups:
99 patients diagnosed with CVA will be randomised into three groups as follows:
Group 1: inhaled corticosteroid+β2 agonist The patients with cough variant asthma received Symbicort Turbuhaler (Budesonide 160µg and Formoterol 4.5µg) 1puff Q12h for 8 weeks.
Group 2: montelukast The patients with cough variant asthma received montelukast 10mg QN for 8 weeks, without any other corticosteroid or β2 agonist.
Group 3: montelukast combined with inhaled corticosteroid+β2 agonist The patients with cough variant asthma received montelukast 10mg QN combined with Symbicort Turbuhaler (Budesonide 160µg and Formoterol 4.5µg) 1puff Q12h for 8 weeks..
The study will be divided into following phases:
- First Visit (Visit 1, day -6): A full medical history and physical examination to be undertaken to determine whether patients meet the inclusion/exclusion criteria. After the informed consent has been signed, the following samples are obtained from all patients: blood samples for routine clinical laboratory tests (haematology, biochemistry and chest x-ray). A urine pregnancy test will be performed in women of childbearing potential. Bronchial provocation test by methacholine inhalation are performed to determined the presence of bronchial non-specific hyper-responsiveness. Patients are given the Diary Card.
- Screening Period ( day -6 to day 0, 6 Days) Patients took two medications as bellows for 3 days and followed by 3 days of wash-out period. Patients should completed 6 days diary card, starting from day -6 to week 0. Bambuterol HCI (Bambec, brand name), 10 mg qn po Theophylline tablet sustained release, 100mg bid po
- Second Visit (Visit 2, Week 0): A physical examination were to be performed. All laboratory tests results are obtained to determine whether patients meet the inclusion/exclusion criteria. Concurrent medication were recorded. The Diary Card were collected, reviewed and assessed whether ICS, bronchodilator or ICS/BD treatment is efficient for cough symptom (symptom score improved 1 at least). Capsaicin challenge test and FENO were performed and hypertonic saline induced sputum samples for cell differential, urine leukotriene, serum IgE, were taken from enrolled patients. Enrolled patients were randomized into different groups, and the study medication were dispensed.
- During Treatment 1(Week 0 to Week 4, 14 days): Patients were to take study medication for 28 days and completed Diary Card for 7 days from Week 3 to Week 4.
- Third Visit (Visit 3, Week 4): A physical examination were to be performed. The Diary Card were collected and reviewed. Adverse events, secondary complications, concurrent medication will be recorded. Capsaicin challenge test and FENO were performed and hypertonic saline induced sputum samples for cell differential were taken from enrolled patients.
- During Treatment 2 (Week 4 to Week 8, 14 days): Patients were to take study medication for 28 days and completed Diary Card for 7 days from Week 7 to Week 8.
- Forth Visit (Visit 4, Week 8):
A physical examination and were to be performed. The Diary Card were collected and reviewed. Residual (unused) medications were to be returned. Adverse events, secondary complications, concurrent medication will be recorded.
Capsaicin challenge test and FENO were performed and hypertonic saline induced sputum samples for cell differential, urine leukotriene, serum IgE, were taken from enrolled patients.
Blood samples for routine clinical laboratory tests (haematology and biochemistry) were obtained, if a clinically significant laboratory abnormal result was noted at the visit 4, AE and a follow-up visit would be considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Montelukast | Active comparator | Drug: MontelukastMonotherapy with Montelukast 10mg, take orally ,every night,for 8 weeks |
| ICS/LABA and Montelukast | Active comparator | Drug: ICS/LABA and MontelukastCombination therapy with inhaled corticosteroid/β2 agonist 160/4.5ug,twice a day and Montelukast 10mg，take orally,every night for 8 weeks |
| ICS/LABA | Active comparator | Drug: ICS/LABAMonotherapy with corticosteroid/β2 agonist 160/4.5ug,inhaled, twice a day, for 8 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who have a history of cough as sole or main symptom lasting more than 8 weeks, often irritating cough more cough at night.
- Patients who were diagnosed with positive result in bronchial provocation test by methacholine inhalation challenge.
- There is evidence that bronchodilator treatment* is efficient for cough symptom (symptom score improved 1 at least).
- Patients whose chest x-ray outcome was normal or without any active focus.
- Patients who was aged from 18 years old (≥ 18 years old ) to 75 years old (≤ 75 years old).
Key exclusion criteria (8 listed)
- Patients demonstrate FEV1/FVC <70% in lung function test. FEV1 stands for forced expiratory volume in 1 second, FVC stands for forced vital capacity.
- Patients who is a smoker or ex-smoker and has smoked within the previous year or has a cumulative smoking history >10 pack-years or equivalence.
- Patients with concomitance of GERC (gastroesophageal reflux-related chronic cough), chronic bronchitis , bronchiectasis, bronchial tuberculosis, ACEI induced cough, bronchogenic carcinoma, psychologic cough, pulmonary fibrosis, bronchus foreign body, microlithiasis, tracheobroncheopathia osteochondroplastica, mediastinal tumor, left ventricular dysfunction.
- Female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study.
- Subjects who are known or suspected to be hypersensitive to any component of the study medication or relief medications.
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 |
|---|---|---|
| ICS/LABAAlso: Symbicort TurbuhalerBudesonide 160µg and Formoterol 4.5µg, 1puff ,twice a day, for 8 weeks | Drug | ICS/LABA |
| MontelukastAlso: SingulairMontelukast 10mg ,every night, for 8 weeks | Drug | Montelukast |
| ICS/LABA and MontelukastAlso: Inhaled corticosteroid/β2 agonist: Symbicort Turbuhaler, Montelukast: SingulairBudesonide 160µg and Formoterol 4.5µg, 1puff, twice a day, for 8 weeks; Montelukast 10mg ,take orally ,every night for 8 weeks | Drug | ICS/LABA and Montelukast |
Primary outcome
Day-time and night-time cough symptom total-score changes from baseline to visit 4
Time frame: 8 weeks
1 secondary outcome
Cough reflex sensitivity changes in different groups at baseline, visit 2, visit3, and visit 4. Cell differential changes in hypertonic saline induced sputum in different groups at baseline, visit 2, visit3, and visit 4.
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
- Derived from this study: PubMed 36217131Yi F, Zhan C, Liu B, Li H, Zhou J, Tang J, Peng W, Luo W, Chen Q, Lai K. Effects of treatment with montelukast alone, budesonide/formoterol alone and a combination of both in cough variant asthma. Respir Res. 2022 Oct 10;23(1):279. doi: 10.1186/s12931-022-02114-6.
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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.
Mengfeng Li, MD. study chair
Sun Yat-sen University
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 ICS/LABA, Montelukast and ICS/LABA and Montelukast in people with Asthma, run by The First Affiliated Hospital of 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 5 inclusion and 8 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 14 Jul 2014. 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. 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 Kefang Lai, PhD (8620 83062893, klai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day-time and night-time cough symptom total-score changes from baseline to visit 4 (time frame: 8 weeks). 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 NCT01404013, which also lists 1 linked publication.
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 14 Jul 2014.