Comparison of Two Treatment Regimens in Asthmatic Patients

January 10, 2012 updated by: Rafal Pawliczak, MD PhD, Medical University of Lodz

A Four Year Observational Study Comparing Two Treatment Regimens: Inhaled Glucocorticosteroid + Salmeterol and Inhaled Glucocorticosteroid + Montelukast.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • 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 Names:
  • Singulair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Control Index
Time Frame: 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%)
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
number of outpatient visits
Time Frame: 12 months
12 months
number of asthma-related hospitalizations
Time Frame: 12 months
12 months
mean value of pulmonary function tests (PEF and FEV1)
Time Frame: 12 months
12 months
number of doctor-defined asthma exacerbations
Time Frame: 12 months
12 months
number of acute respiratory infections
Time Frame: 12 months
12 months
number of nocturnal and day-time dyspneas
Time Frame: 12 months
12 months
number of episodes of wheeze
Time Frame: 12 months
12 months
exact prescribed doses of anti-inflammatory drugs
Time Frame: 12 months
12 months
number of prescribed containers of short-acting β2-agonists, antihistamines, and antibiotics
Time Frame: 12 months
12 months
number of pulmonary function tests declines below 80% personal best
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1995

Primary Completion (ACTUAL)

June 1, 2006

Study Completion (ACTUAL)

June 1, 2006

Study Registration Dates

First Submitted

December 6, 2011

First Submitted That Met QC Criteria

December 7, 2011

First Posted (ESTIMATE)

December 8, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2012

Last Update Submitted That Met QC Criteria

January 10, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • adamusiak-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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