Comparison of Two Treatment Regimens in Asthmatic Patients
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Purpose
The objective of the study was to compare in real life clinical practice two treatment regimens: inhaled glucocorticosteroid + salmeterol and inhaled glucocorticosteroid + montelukast.
| Condition | Intervention |
|---|---|
|
Asthma |
Drug: first prescription of montelukast Drug: first prescription of salmeterol |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Crossover Time Perspective: Retrospective |
| Official Title: | A Four Year Observational Study Comparing Two Treatment Regimens: Inhaled Glucocorticosteroid + Salmeterol and Inhaled Glucocorticosteroid + Montelukast. |
- Asthma Control Index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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%)
- number of outpatient visits [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- number of asthma-related hospitalizations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- mean value of pulmonary function tests (PEF and FEV1) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- number of doctor-defined asthma exacerbations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- number of acute respiratory infections [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- number of nocturnal and day-time dyspneas [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- number of episodes of wheeze [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- exact prescribed doses of anti-inflammatory drugs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- number of prescribed containers of short-acting β2-agonists, antihistamines, and antibiotics [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- number of pulmonary function tests declines below 80% personal best [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 132 |
| Study Start Date: | April 1995 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned 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. |
Drug: first prescription of salmeterol
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.
Other Name: Serevent
|
|
ICS + montelukast
Patients treated with both inhaled glucocorticosteroid (ICS) and montelukast (leukotriene receptor antagonist). 42 patients met the inclusion criteria for this group. |
Drug: first prescription of montelukast
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.
Other Name: Singulair
|
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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
Contacts and Locations| Principal Investigator: | Rafal Pawliczak, MD PhD | Department of Immunopathology Chair of Allergy, Immunology and Dermatology Faculty of Biomedical Sciences and Postgraduate Training Medical University of Lodz |
More Information
No publications provided
| Responsible Party: | Rafal Pawliczak, MD PhD, Prof. Rafal Pawliczak, Medical Universtity of Lodz |
| ClinicalTrials.gov Identifier: | NCT01488773 History of Changes |
| Other Study ID Numbers: | adamusiak-01 |
| Study First Received: | December 6, 2011 |
| Last Updated: | January 10, 2012 |
| Health Authority: | Poland: Ethics Committee |
Keywords provided by Medical Universtity of Lodz:
|
asthma asthma control inhaled glucocorticosteroid ICS leukotriene antagonist LTRA |
montelukast fluticasone salmeterol observational study repeated measures retrospective |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Salmeterol Montelukast Leukotriene Antagonists Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists |
Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 21, 2013