Comparison of Two Treatment Regimens in Asthmatic Patients

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488773
• Other study ID #: adamusiak-01
• Status: Completed
• Phase: N/A
• First received: December 6, 2011
• Last updated: January 10, 2012
• Start date: April 1995
• Est. completion date: June 2006

Study information

• Verified date: January 2012
• Source: Medical Universtity of Lodz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Crossover, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• first prescription of salmeterol
The index event (intervention) was defined as the first prescription for salmeterol (long-acting ß2-agonist) occurring in patient's medical history that established a 12-month pre-index and three consecutive 12-month post-index periods.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical Universtity of Lodz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Index	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 ß2-agonist utilization (0, less or half a container a year, more than half a container a year);FEV1 (>90%,>80%,<80%)	12 months	No
Secondary	number of outpatient visits		12 months	No
Secondary	number of asthma-related hospitalizations		12 months	No
Secondary	mean value of pulmonary function tests (PEF and FEV1)		12 months	No
Secondary	number of doctor-defined asthma exacerbations		12 months	No
Secondary	number of acute respiratory infections		12 months	No
Secondary	number of nocturnal and day-time dyspneas		12 months	No
Secondary	number of episodes of wheeze		12 months	No
Secondary	exact prescribed doses of anti-inflammatory drugs		12 months	No
Secondary	number of prescribed containers of short-acting ß2-agonists, antihistamines, and antibiotics		12 months	No
Secondary	number of pulmonary function tests declines below 80% personal best		12 months	No