Longitudinal Assessment of Clinical Course and BIOmarkers in Severe Chronic AIRway Disease

Karolinska Institutet1 site in 1 country233 target enrollmentMarch 2002

ConditionsAsthma COPD

Interventionsprednisolone

Drugsprednisolone

Overview

Phase: Not Applicable
Intervention: prednisolone
Conditions: Asthma
Sponsor: Karolinska Institutet
Enrollment: 233
Locations: 1
Primary Endpoint: Number of exacerbations
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the project is to study pathogenetic mechanisms in severe asthma and compare those mechanisms in chronic obstructive pulmonary disease (COPD) in order to test the hypothesis that severe asthma and COPD develop into similar chronic degenerative changes.

Detailed Description

The BIOAIR project focuses on the sub-group of asthma patients that suffer from severe or difficult-to-control asthma, and who have frequent asthma exacerbations ('attacks'). This sub-group of asthma patients consists of around 10% of all asthma patients, but accounts for more than half of the total community costs for asthma. It is as yet unknown why these patients are so much more severely ill compared to the majority of asthma patients that have controlled disease. No adequate treatment has yet been established. The BIOAIR study was initiated in order to find out more about the mechanisms underlying severe asthma. Since some of the changes that occur in severe asthma are similar to patients with chronic obstructive lung disease (COPD), a group of COPD patients was included and will be studied as well. A group with controlled mild-to-moderate asthma was included for comparative reasons.

Registry

clinicaltrials.gov

Start Date

March 2002

End Date

December 2026

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Karolinska Institutet

Responsible Party

Principal Investigator

Sven-Erik Dahlén

Professor

Karolinska Institutet

Eligibility Criteria

Inclusion Criteria

•For all patients:
•The patient understands the study procedures and agrees to participate by signing the consent form.
•The patient is male or female, at least 18 years of age but no more than 80 years of age at the entry into the study (screening visit).
•For patients with asthma (groups 1 and 2)
•The patient has a history of intermittent or persistent symptoms of wheezing, breathlessness, chest tightness and cough. The diagnosis of asthma must have been confirmed by a specialist in pulmonary medicine.
•The patient fulfils one or several of the following criteria for reversible airway obstruction, as documented during the last 5 years before the study or at screening visit:
•An increase in FEV1 more than 9% of predicted (or improvement by 200 mL) after administration of 4 puffs of 100 microg salbutamol dose-aerosol inhaler via a spacer, or after additional inhalation of four puffs of 20 microg ipratropium bromide (Atrovent) administered through a large volume spacer.
•A mean diurnal variation in Peak Expiratory Flow (PEF) of more than 15% on more than 4 days/week for at least 2 weeks, as calculated by the following equation:
•(highest PEF-lowest PEF)/mean PEF
•An increase in FEV1 of at least 400 mL after a course of prednisolone 0.5mg/kg/day for 14 days.

Exclusion Criteria

•General exclusions
•The patient is pregnant.
•The patient has a recent history of incapacitating psychotic disorders.
•The patient is a current or recent past abuser of alcohol or illicit drugs.
•The patient has a history of malignancy, is known to be positive for HIV, or other states that are considered to interfere with study conduct or scientific interpretations.
•The patient cannot read or comprehend written material, or is in the opinion of the investigator, for other reasons unlikely to understand and follow the study procedures.
•The patient is mentally or legally incapacitated preventing informed consent from being obtained.
•Exclusions because of pulmonary disorders
•The patient is unable to perform acceptable spirometry, peak flow measurements and/or complete diary cards in a satisfactory way during the period between visit 1 and visit 3B (optimisation period and prednisolone/placebo trial). If the patient is unable to use the electronic Peak Flow meters/Diary cards, it is acceptable to use an ordinary mechanical meter (e.g. Mini-Wright) together with a paper version of the diary card. Patients that are unable to use the mechanical meter and paper diary card during the period between visit 1 and 3B cannot enter the follow-up year.
•The patient has, in addition to asthma or COPD, any other pulmonary disorder that according to the investigator would interfere with the study procedures or scientific evaluation (e.g. tuberculosis).