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The objective of the study was to compare in real life clinical practice two treatment regimens: inhaled glucocorticosteroid + salmeterol and inhaled glucocorticosteroid + montelukast.
48 month pre/post retrospective repeated measures design was used to compare the level of asthma control among patients continuously treated at the Outpatient Asthma and Allergy Treatment Center, Chair of Clinical Immunology and Microbiology, Medical University of Lodz, Poland.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICS + salmeterol | Patients treated with both inhaled glucocorticosteroid (ICS) and salmeterol (long-acting β2-agonist). 90 patients met the inclusion criteria for this group. |
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| ICS + montelukast | Patients treated with both inhaled glucocorticosteroid (ICS) and montelukast (leukotriene receptor antagonist). 42 patients met the inclusion criteria for this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| first prescription of montelukast | Drug | The index event (intervention) was defined as the first prescription for montekuast (leukotriene receptor antagonist) occurring in patient's medical history that established a 12-month pre-index and three consecutive 12-month post-index periods. |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Index | A composite measure based on GINA 2006 guidelines and Asthma Control Questionnaire© (ACQ) by Juniper et al. Each of the five parameter was assessed on a three-level scale 2 - 1 - 0 and summed up to provide the final score between 0 (uncontrolled asthma) and 10 (controlled asthma). These parameters were: Nocturnal dyspnea (none, 1, 1+);Daytime dyspena (none, 1, 1+);Wheeze (none, 1, 1+);short-acting β2-agonist utilization (0, less or half a container a year, more than half a container a year);FEV1 (>90%,>80%,<80%) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| number of outpatient visits | 12 months | |
| number of asthma-related hospitalizations | 12 months | |
| mean value of pulmonary function tests (PEF and FEV1) |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consisted of 5563 patients continuously treated for bronchial asthma (28% of all patients) at the Outpatient Asthma and Allergy Treatment Center, Chair of Clinical Immunology and Microbiology, Medical University of Lodz, Poland in the period from April 1995 through June 2006.
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| Name | Affiliation | Role |
|---|---|---|
| Rafal Pawliczak, MD PhD | Department of Immunopathology Chair of Allergy, Immunology and Dermatology Faculty of Biomedical Sciences and Postgraduate Training Medical University of Lodz | Principal Investigator |
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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 |
|---|---|
| C093875 | montelukast |
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 |
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| first prescription of salmeterol | Drug | The index event (intervention) was defined as the first prescription for salmeterol (long-acting β2-agonist) occurring in patient's medical history that established a 12-month pre-index and three consecutive 12-month post-index periods. |
|
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| 12 months |
| number of doctor-defined asthma exacerbations | 12 months |
| number of acute respiratory infections | 12 months |
| number of nocturnal and day-time dyspneas | 12 months |
| number of episodes of wheeze | 12 months |
| exact prescribed doses of anti-inflammatory drugs | 12 months |
| number of prescribed containers of short-acting β2-agonists, antihistamines, and antibiotics | 12 months |
| number of pulmonary function tests declines below 80% personal best | 12 months |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |