Clinical trial NCT01488773: Comparison of Two Treatment Regimens in Asthmatic Patients
Official title: A Four Year Observational Study Comparing Two Treatment Regimens: Inhaled Glucocorticosteroid + Salmeterol and Inhaled Glucocorticosteroid + Montelukast.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: asthma
asthma control
inhaled glucocorticosteroid
ICS
leukotriene antagonist
LTRA
montelukast
fluticasone
salmeterol
observational study
repeated measures
retrospective
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2011-12-08
Enrollment: 132
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of 5563 patients continuously treated for bronchial asthma (28% of all patients) at the Outpatient Asthma and Allergy Treatment Center, Chair of Clinical Immunology and Microbiology, Medical University of Lodz, Poland in the period from April 1995 through June 2006.

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.

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

Primary outcomes:
measure: Asthma Control Index
timeFrame: 12 months
Secondary outcomes:
measure: number of outpatient visits
timeFrame: 12 months
measure: number of asthma-related hospitalizations
timeFrame: 12 months
measure: mean value of pulmonary function tests (PEF and FEV1)
timeFrame: 12 months
measure: number of doctor-defined asthma exacerbations
timeFrame: 12 months
measure: number of acute respiratory infections
timeFrame: 12 months
measure: number of nocturnal and day-time dyspneas
timeFrame: 12 months
measure: number of episodes of wheeze
timeFrame: 12 months
measure: exact prescribed doses of anti-inflammatory drugs
timeFrame: 12 months
measure: number of prescribed containers of short-acting β2-agonists, antihistamines, and antibiotics
timeFrame: 12 months
measure: number of pulmonary function tests declines below 80% personal best
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Department of Immunopathology Chair of Allergy, Immunology and Dermatology Faculty of Biomedical Sciences and Postgraduate Training Medical University of Lodz
name: Rafal Pawliczak, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: