Asthmatic SmokersPhase 4NCT00712335
The Effects of Montelukast on Smokers With Asthma
A Phase 4 study testing Fluticasone Propionate, Montelukast and Salmeterol in people with Asthmatic Smokers and Non-asthmatic Smokers, run by Inje University at 1 site in South Korea.
Trial summary
The purpose of this study is: 1. To compare neutrophilia, eosinophilic inflammatory markers and asthma symptom indices between smokers and non-smokers. 2. To elucidate the mechanism by which cigarette smokers are resistant to corticosteroids. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthmatic Smokers, Non-asthmatic Smokers
- What is being tested?
- Fluticasone Propionate, Montelukast and Salmeterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2007to May 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Asthmatics:
- clinical history of asthma for at least 1 year
- with evidence of reversible airway obstruction,
- two documented FEV1 between 60-85%,
- PC20 < 4mg/ml by methacholine challenge test
- and average baseline β-agonist use of 2 puffs/day
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- Smokers:
- smoke 1/2 to 2 packs a day
- with a smoking history of 5-30 pack years
- Non-smokers:
- Non-smokers will have either never smoked or have stopped smoking cigarettes over 5 years ago
Who cannot join
- positive HCG (for females)
- have a respiratory tract infection or need oral corticosteroids within the preceding 6 weeks
- history of COPD or respiratory disorder other than asthma
- history of psychiatric illness
- allergy to fluticasone propionate, salmeterol, montelukast or any of their components
- significant, unstable medical condition other than asthma
- history of life-threatening asthma exacerbation requiring intubation and mechanical ventilation in the last ten years
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asthma and Allergy Center, Inje University Sanggye Paik Hospital
Seoul, 139-707
About this study
Official title: The Effects of Montelukast on Sputum Cells and Inflammatory Markers in Smokers With Asthma
The purpose of this study is:
- To compare neutrophilia, eosinophilic inflammatory markers and asthma symptom indices between smokers and non-smokers.
- To elucidate the mechanism by which cigarette smokers are resistant to corticosteroids.
Read the detailed description
Many smokers have insufficient control of their symptoms due to inefficacy of ICS in this subpopulation of asthmatics. Cigarette smoking has been shown to stimulate production of cysLTs. CysLTs could activate production of IL-8 for neutrophilia as well as cause eosinophilia in the airway of asthmatics.
LTRAs are felt to be less efficacious than ICS in smokers with asthma. However, LTRA's unique mechanism of action could be particularly efficacious in preventing worsening symptoms and lung function for smokers with asthma. Given this, along with the fact that ICS are less effective in smokers, targeting cysLT could lead to significant clinical benefits for asthmatic smokers.
Data from this study may possibly serve as crucial data for the significant clinical benefits for asthmatic smokers and determination of the mechanism of corticosteroid resistance in smokers with asthma.
- Conditions
- Asthmatic Smokers, Non-asthmatic Smokers
- Being tested
- Fluticasone Propionate, Montelukast, Salmeterol
- Keywords
- asthmatics, smokers, inhaled corticosteroids, leukotriene receptor antagonists
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone PropionateDrug
Also called inhaled corticosteroid
DPI 250 mcg BID for 3 weeks
MontelukastDrug
Also called leukotriene receptor antagonist
PO 10 mg QHS for 3 weeks
SalmeterolDrug
Also called long-acting beta-agonist
DPI 50mg BID for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Asthmatic smokers treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months Receives: Drug: Fluticasone Propionate; Drug: Salmeterol |
| 2 | Experimental | Asthmatic smoker treated with Montelukast only:
Montelukast dosage: PO 10 mg QHS for 3 months Receives: Drug: Montelukast |
| 3 | Active comparator | Non-smoking asthmatics treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months Receives: Drug: Fluticasone Propionate; Drug: Salmeterol |
| 4 | Active comparator | Non-smoking asthmatic treated with Montelukast only:
Montelukast dosage: PO 10 mg QHS for 3 months Receives: Drug: Montelukast |
| 5 | No intervention | Normal controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum Neutrophil Percentages
Week 24 sputum neutrophil percentages were measured in active treatment groups.
Measured: 24 weeks
Secondary outcomes (6)
Sputum Eosinophil Percentages
Secondary endpoints of inflammatory markers (sputum eosinophil percentages at 24 weeks) were measured in active treatment groups
Measured: 24 weeks
Sputum IL-8 Levels
Week 24 sputum IL-8 levels in active treatment groups
Measured: 24 weeks
Sputum GM-CSF Levels
Week 24 sputum GM-CSF levels in active treatment groups were measured.
Measured: 24 weeks
Sputum IFN-gamma/IL-5 Ratios
Week 24 sputum IFN-gamma/IL-5 ratios were determined in active treatment groups.
Measured: 24 weeks
Sputum Eotaxin Levels
Week 24 sputum eotaxin levels in active treatment groups were measured.
Measured: 24 weeks
Sputum RANTES Levels
Week 24 sputum RANTES levels in active treatment groups were measured.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startFeb 2007
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Asthmatic SmokersStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Keun Kim, Dr., Inje University
- Investigators
- Chang-Keun Kim, MD, PhD, Principal investigator, Asthma and Allergy Center, Inje University Sanggye Paik Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712335
- Sponsor's protocol ID
- MASK2008
- Status last verified
- Apr 2012
- First submitted
- 7 Jul 2008
- Last updated
- 16 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Montelukast on Sputum Cells and Inflammatory Markers in Smokers With Asthma
- ClinicalTrials.gov ID
- NCT00712335
- Acronym / sponsor ID
- MASK2008
- Conditions
- Asthmatic Smokers, Non-asthmatic Smokers
- Keywords
- asthmatics, smokers, inhaled corticosteroids, leukotriene receptor antagonists
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Jul 2008 (estimated)
- Results
- Posted 16 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is:
- To compare neutrophilia, eosinophilic inflammatory markers and asthma symptom indices between smokers and non-smokers.
- To elucidate the mechanism by which cigarette smokers are resistant to corticosteroids.
Detailed description
Many smokers have insufficient control of their symptoms due to inefficacy of ICS in this subpopulation of asthmatics. Cigarette smoking has been shown to stimulate production of cysLTs. CysLTs could activate production of IL-8 for neutrophilia as well as cause eosinophilia in the airway of asthmatics.
LTRAs are felt to be less efficacious than ICS in smokers with asthma. However, LTRA's unique mechanism of action could be particularly efficacious in preventing worsening symptoms and lung function for smokers with asthma. Given this, along with the fact that ICS are less effective in smokers, targeting cysLT could lead to significant clinical benefits for asthmatic smokers.
Data from this study may possibly serve as crucial data for the significant clinical benefits for asthmatic smokers and determination of the mechanism of corticosteroid resistance in smokers with asthma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fluticasone Propionate, Drug: SalmeterolAsthmatic smokers treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months |
| 2 | Experimental | Drug: MontelukastAsthmatic smoker treated with Montelukast only: Montelukast dosage: PO 10 mg QHS for 3 months |
| 3 | Active comparator | Drug: Fluticasone Propionate, Drug: SalmeterolNon-smoking asthmatics treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months |
| 4 | Active comparator | Drug: MontelukastNon-smoking asthmatic treated with Montelukast only: Montelukast dosage: PO 10 mg QHS for 3 months |
| 5 | No intervention | –Normal controls |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- clinical history of asthma for at least 1 year
- with evidence of reversible airway obstruction,
- two documented FEV1 between 60-85%,
- PC20 < 4mg/ml by methacholine challenge test
- and average baseline β-agonist use of 2 puffs/day
Key exclusion criteria (7 listed)
- positive HCG (for females)
- have a respiratory tract infection or need oral corticosteroids within the preceding 6 weeks
- history of COPD or respiratory disorder other than asthma
- history of psychiatric illness
- allergy to fluticasone propionate, salmeterol, montelukast or any of their components
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 |
|---|---|---|
| Fluticasone PropionateAlso: inhaled corticosteroidDPI 250 mcg BID for 3 weeks | Drug | 1, 3 |
| MontelukastAlso: leukotriene receptor antagonistPO 10 mg QHS for 3 weeks | Drug | 2, 4 |
| SalmeterolAlso: long-acting beta-agonistDPI 50mg BID for 3 weeks | Drug | 1, 3 |
Primary outcome
Sputum Neutrophil Percentages
Time frame: 24 weeks
Week 24 sputum neutrophil percentages were measured in active treatment groups.
6 secondary outcomes
Sputum Eosinophil Percentages
Time frame: 24 weeks
Sputum IL-8 Levels
Time frame: 24 weeks
Sputum GM-CSF Levels
Time frame: 24 weeks
Sputum IFN-gamma/IL-5 Ratios
Time frame: 24 weeks
Sputum Eotaxin Levels
Time frame: 24 weeks
Sputum RANTES Levels
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Chang-Keun Kim, MD, PhD principal investigator
Asthma and Allergy Center, Inje University Sanggye Paik Hospital
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 Fluticasone Propionate, Montelukast and Salmeterol in people with Asthmatic Smokers and Non-asthmatic Smokers, run by Inje University at 1 site in South Korea.
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 11 inclusion and 7 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: finished, as of the sponsor's last update on 16 May 2012. 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 South Korea. 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?
Yes. Results are posted in the registry (first posted 16 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sputum Neutrophil Percentages (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2012.