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Completed

NCT Number: NCT01488773

Comparison of Two Treatment Regimens in Asthmatic Patients

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

first prescription of montelukast

Drug

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

first prescription of salmeterol

Drug

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

Primary outcomes

  1. 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%)

Secondary outcomes

  1. number of outpatient visits

    Time frame: 12 months

  2. number of asthma-related hospitalizations

    Time frame: 12 months

  3. mean value of pulmonary function tests (PEF and FEV1)

    Time frame: 12 months

  4. number of doctor-defined asthma exacerbations

    Time frame: 12 months

  5. number of acute respiratory infections

    Time frame: 12 months

  6. number of nocturnal and day-time dyspneas

    Time frame: 12 months

  7. number of episodes of wheeze

    Time frame: 12 months

  8. exact prescribed doses of anti-inflammatory drugs

    Time frame: 12 months

  9. number of prescribed containers of short-acting β2-agonists, antihistamines, and antibiotics

    Time frame: 12 months

  10. number of pulmonary function tests declines below 80% personal best

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study title

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

Important dates

Study start
1995
Primary completion
2006
Study completion
2006
First posted
Dec 8, 2011
Registry last updated
Jan 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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