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The purpose of this study is:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 2 | Experimental | Asthmatic smoker treated with Montelukast only: Montelukast dosage: PO 10 mg QHS for 3 months |
|
| 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 |
|
| 4 | Active Comparator | Non-smoking asthmatic treated with Montelukast only: Montelukast dosage: PO 10 mg QHS for 3 months |
|
| 5 | No Intervention | Normal controls |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Propionate | Drug | DPI 250 mcg BID for 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sputum Neutrophil Percentages | Week 24 sputum neutrophil percentages were measured in active treatment groups. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sputum Eosinophil Percentages | Secondary endpoints of inflammatory markers (sputum eosinophil percentages at 24 weeks) were measured in active treatment groups | 24 weeks |
| Sputum IL-8 Levels | Week 24 sputum IL-8 levels in active treatment groups |
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Inclusion Criteria:
Asthmatics:
Smokers:
Non-smokers:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chang-Keun Kim, MD, PhD | Asthma and Allergy Center, Inje University Sanggye Paik Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asthma and Allergy Center, Inje University Sanggye Paik Hospital | Seoul | 139-707 | South Korea |
After randomization, a 10-day washout period followed in which subjects were taken off all medications except albuterol metered dose inhaler as needed. After the washout period, baseline induced sputum was obtained in each group along with primary and secondary endpoints. This was followed by a 3-week run in period.
Recruitment period: January 2008-April 2011 Recruitment location: Asthma and Allergy Center, Inje University Sanggye Paik Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | Asthmatic Smokers Treated With Combination Therapy | 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 |
| FG001 | Asthmatic Smoker Treated With Montelukast Only | Asthmatic smoker treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months |
| FG002 | Non-smoking Asthmatic Treated With Combination Therapy | Non-smoking asthmatic treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months |
| FG003 | Non-smoking Asthmatic Treated With Montelukast Only | Non-smoking asthmatic treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months |
| FG004 | Normal Controls | Normal controls did not receive any treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Asthmatic Smokers Treated With Combination Therapy | 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 |
| BG001 | Asthmatic Smoker Treated With Montelukast Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Sputum Eosinophil Percentages | Secondary endpoints of inflammatory markers (sputum eosinophil percentages at 24 weeks) were measured in active treatment groups | We will use ITT and PP protocols for analysis | Posted | Mean | Standard Deviation | percentage of eosinophils | 24 weeks |
|
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Normal Controls were not assessed for Adverse Events because they were not administered any treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Asthmatic Smokers Treated With Combination Therapy | 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 |
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It is difficult attaining representative gender ratios (i.e., representative of the general population) when conducting a smoking study in Korea, as smoking by females is still considered culturally taboo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chang-Keun Kim | Inje University | 82-2-950-8832 | kimck@paik.ac.kr |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| C093875 | montelukast |
| D020024 | Leukotriene Antagonists |
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Montelukast | Drug | PO 10 mg QHS for 3 weeks |
|
|
| Salmeterol | Drug | DPI 50mg BID for 3 weeks |
|
|
| 24 weeks |
| Sputum GM-CSF Levels | Week 24 sputum GM-CSF levels in active treatment groups were measured. | 24 weeks |
| Sputum IFN-gamma/IL-5 Ratios | Week 24 sputum IFN-gamma/IL-5 ratios were determined in active treatment groups. | 24 weeks |
| Sputum Eotaxin Levels | Week 24 sputum eotaxin levels in active treatment groups were measured. | 24 weeks |
| Sputum RANTES Levels | Week 24 sputum RANTES levels in active treatment groups were measured. | 24 weeks |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Lack of Efficacy |
|
| Other Reason |
|
Asthmatic smoker treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months |
| BG002 | Non-smoking Asthmatic Treated With Combination Therapy | Non-smoking asthmatic treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months |
| BG003 | Non-smoking Asthmatic Treated With Montelukast Only | Non-smoking asthmatic treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months |
| BG004 | Normal Controls | Normal controls did not receive any treatment. |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Non-smoking Asthmatic Treated With Combination Therapy | Non-smoking asthmatic treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months |
| OG003 | Non-smoking Asthmatic Treated With Montelukast Only | Non-smoking asthmatic treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months |
| OG004 | Normal Controls | Normal controls did not receive any treatment. |
|
|
| Primary | Sputum Neutrophil Percentages | Week 24 sputum neutrophil percentages were measured in active treatment groups. | We will be using intention-to-treat and per protocol for analysis. | Posted | Mean | Standard Deviation | percentage of neutrophils | 24 weeks |
|
|
|
| Secondary | Sputum IL-8 Levels | Week 24 sputum IL-8 levels in active treatment groups | We will ITT and PP protocols for analysis | Posted | Mean | Standard Deviation | pg/ml | 24 weeks |
|
|
|
| Secondary | Sputum GM-CSF Levels | Week 24 sputum GM-CSF levels in active treatment groups were measured. | We will use ITT and PP for analysis | Posted | Mean | Standard Deviation | pg/ml | 24 weeks |
|
|
|
| Secondary | Sputum IFN-gamma/IL-5 Ratios | Week 24 sputum IFN-gamma/IL-5 ratios were determined in active treatment groups. | ITT and PP were used for analysis. | Posted | Mean | Standard Deviation | ratio | 24 weeks |
|
|
|
| Secondary | Sputum Eotaxin Levels | Week 24 sputum eotaxin levels in active treatment groups were measured. | ITT and PP were used for analysis. | Posted | Mean | Standard Deviation | pg/ml | 24 weeks |
|
|
|
| Secondary | Sputum RANTES Levels | Week 24 sputum RANTES levels in active treatment groups were measured. | ITT and PP were used for analysis. | Posted | Mean | Standard Deviation | pg/ml | 24 weeks |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Asthmatic Smoker Treated With Montelukast Only | Asthmatic smoker treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months | 0 | 32 | 0 | 32 |
| EG002 | Non-smoking Asthmatic Treated With Combination Therapy | Non-smoking asthmatic treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months | 0 | 11 | 0 | 11 |
| EG003 | Non-smoking Asthmatic Treated With Montelukast Only | Non-smoking asthmatic treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months | 0 | 24 | 0 | 24 |
| EG004 | Normal Controls | Normal controls did not receive any treatment. | 0 | 0 | 0 | 0 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |