Comparison of Two Treatment Regimens in Asthmatic Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Four Year Observational Study Comparing Two Treatment Regimens: Inhaled Glucocorticosteroid + Salmeterol and Inhaled Glucocorticosteroid + Montelukast.

Conditions
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Asthma

Intervention / Treatment
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* Drug: first prescription of montelukast
* Drug: first prescription of salmeterol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of asthma according to the WHO/GINA 2006 definition by the physicians of the Centre, backed up by detailed medical history and physical examination as well as additional spirometry and bronchodilatation test or methacholine challenge where necessary Occurrence of an index event (intervention) defined as the first prescription for salmeterol or montelukast, establishing a 12-month pre-index and three consecutive 12-month post-index periods At least one inhaled glucocorticosteroid prescription in the pre-index period, and at least one salmeterol/montelukast prescription depending on the arm in every post-index period Exclusion Criteria: Incomplete diagnostics
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICS + salmeterol<br>Patients treated with both inhaled glucocorticosteroid (ICS) and salmeterol (long-acting β2-agonist). 90 patients met the inclusion criteria for this group. | Drug: first prescription of salmeterol<br>* 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.<br>* Other names: Serevent;|
| ICS + montelukast<br>Patients treated with both inhaled glucocorticosteroid (ICS) and montelukast (leukotriene receptor antagonist). 42 patients met the inclusion criteria for this group. | Drug: first prescription of montelukast<br>* 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.<br>* Other names: Singulair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, asthma control, inhaled glucocorticosteroid, ICS, leukotriene antagonist, LTRA, montelukast, fluticasone, salmeterol, observational study, repeated measures, retrospective