A Four Year Observational Study Comparing Two Treatment Regimens: Inhaled Glucocorticosteroid + Salmeterol and Inhaled Glucocorticosteroid + Montelukast.
Overview
- Phase
- Not Applicable
- Intervention
- first prescription of salmeterol
- Conditions
- Asthma
- Sponsor
- Medical University of Lodz
- Enrollment
- 132
- Primary Endpoint
- Asthma Control Index
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Rafal Pawliczak, MD PhD
Prof. Rafal Pawliczak
Medical University of Lodz
Eligibility Criteria
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
Arms & Interventions
ICS + salmeterol
Patients treated with both inhaled glucocorticosteroid (ICS) and salmeterol (long-acting β2-agonist). 90 patients met the inclusion criteria for this group.
Intervention: first prescription of salmeterol
ICS + montelukast
Patients treated with both inhaled glucocorticosteroid (ICS) and montelukast (leukotriene receptor antagonist). 42 patients met the inclusion criteria for this group.
Intervention: first prescription of montelukast
Outcomes
Primary Outcomes
Asthma Control Index
Time Frame: 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 Outcomes
- number of doctor-defined asthma exacerbations(12 months)
- exact prescribed doses of anti-inflammatory drugs(12 months)
- 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 acute respiratory infections(12 months)
- number of nocturnal and day-time dyspneas(12 months)
- number of episodes of wheeze(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)