Comparison of Two Treatment Regimens in Asthmatic Patients

Completed

• Conditions: Asthma
• Interventions: Drug: first prescription of salmeterol; Drug: first prescription of montelukast

• Registration Number: NCT01488773
• Lead Sponsor: Medical University of Lodz

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.

Study Timeline

• Study Start: 1995-04
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Study First Submitted: 2011-12-06
• Study First Submitted QC: 2011-12-07
• Study First Posted: 2011-12-08
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-10
• Last Update Posted: 2012-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

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Exclusion Criteria

• Incomplete diagnostics

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICS + salmeterol	first prescription of salmeterol	Patients treated with both inhaled glucocorticosteroid (ICS) and salmeterol (long-acting β2-agonist). 90 patients met the inclusion criteria for this group.
ICS + montelukast	first prescription of montelukast	Patients treated with both inhaled glucocorticosteroid (ICS) and montelukast (leukotriene receptor antagonist). 42 patients met the inclusion criteria for this group.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
number of asthma-related hospitalizations	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 doctor-defined asthma exacerbations	12 months
exact prescribed doses of anti-inflammatory drugs	12 months
number of outpatient visits	12 months
mean value of pulmonary function tests (PEF and FEV1)	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