Comparison of Two Treatment Regimens in Asthmatic Patients

Medical University of Lodz132 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

132

Conditions

Asthma

Interventions

first prescription of montelukastDRUG

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.

first prescription of salmeterolDRUG

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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%)

Time frame: 12 months

Secondary Outcomes

number of outpatient visits

Time frame: 12 months

number of asthma-related hospitalizations

Time frame: 12 months

mean value of pulmonary function tests (PEF and FEV1)

Time frame: 12 months

number of doctor-defined asthma exacerbations

Time frame: 12 months

number of acute respiratory infections

Time frame: 12 months

number of nocturnal and day-time dyspneas

Time frame: 12 months

number of episodes of wheeze

Time frame: 12 months

exact prescribed doses of anti-inflammatory drugs

Time frame: 12 months

number of prescribed containers of short-acting β2-agonists, antihistamines, and antibiotics

Data from ClinicalTrials.gov

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