Asthma
Conditions
Keywords
asthma, asthma control, inhaled glucocorticosteroid, ICS, leukotriene antagonist, LTRA, montelukast, fluticasone, salmeterol, observational study, repeated measures, retrospective
Brief summary
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
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.
Interventions
DRUGfirst prescription of montelukast
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.
DRUGfirst prescription of salmeterol
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.
Sponsors
Medical University of Lodz
Study design
Observational model
CASE_CROSSOVER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Index | 12 months | 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%) |
Secondary
| Measure | Time frame |
|---|---|
| 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 outpatient visits | 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 |
| number of nocturnal and day-time dyspneas | 12 months |
Outcome results
None listed