Comparison of Two Treatment Regimens in Asthmatic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rafal Pawliczak, MD PhD, Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT01488773
First received: December 6, 2011
Last updated: January 10, 2012
Last verified: January 2012
  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.

Resource links provided by NLM:


Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:
  • 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%)



Secondary Outcome Measures:
  • 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
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488773

Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
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:
Leukotriene Antagonists
Montelukast
Salmeterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014