Comparison of Two Treatment Regimens in Asthmatic Patients

Medical University of Lodz

Status: Completed

Conditions: Asthma

Treatments: Drug: first prescription of salmeterol; Drug: first prescription of montelukast

Study type: Observational

Funder types: Other

Identifiers

NCT01488773

adamusiak-01

Details and patient eligibility

About

The objective of the study was to compare in real life clinical practice two treatment regimens: inhaled glucocorticosteroid + salmeterol and inhaled glucocorticosteroid + montelukast.

Full 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.

Enrollment: 132 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

132 participants in 2 patient groups

ICS + salmeterol

Description:

Patients treated with both inhaled glucocorticosteroid (ICS) and salmeterol (long-acting β2-agonist). 90 patients met the inclusion criteria for this group.

Treatment:

Drug: first prescription of salmeterol

ICS + montelukast

Description:

Patients treated with both inhaled glucocorticosteroid (ICS) and montelukast (leukotriene receptor antagonist). 42 patients met the inclusion criteria for this group.

Treatment:

Drug: first prescription of montelukast