Stepping Down of Asthma Medication in Controlled Asthma

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Background:

The most common asthma drugs, namely inhaled glucocorticoids (ICS) and long-acting beta-2 sympathomimetic drugs (LABA) carry a risk of adverse effects, some of which being potentially severe. Therefore, current guidelines for asthma management recommend that, after a period of symptom control, a reduction of the dose and cessation of the ICSs and LABAs should be attempted. However, reduction in asthma medications sometimes leads to an exacerbation of asthma. Therefore both physicians and asthmatics are often reluctant to reduce or stop asthma medications and asthma over-medication often occurs. A test that could identify those asthmatics who probably would tolerate asthma medication reduction would be useful.

Objectives:

1. To investigate whether airway responsiveness to hypertonic saline can predict the outcome of asthma treatment reduction in subjects with controlled asthma.

2. To get an estimate about how large a proportion of Finnish asthmatic patients use their medications with unnecessarily high doses or would even manage well without any asthma medications.

Study hypothesis:

1. Airway responsiveness to hypertonic saline can predict the outcome of asthma treatment reduction

2. Most of the Finnish asthmatic patients use their medications with unnecessarily high doses

Methods:

This is a prospective study in which the physician responsible for the subject management and medications is blinded from the saline challenge results and the nurse performing the saline challenges is blinded from medications 70 asthmatic patients with both inhaled ICS and LABA will be recruited. Asthma must be well controlled (Juniper's Asthma Control Questionnaire score equal or less than 0.75 ).

The asthma medications will be reduced in three steps, in six weeks' intervals, up to total cessation of asthma drugs or up to asthma exacerbation. The criteria for asthma exacerbation are strictly defined. First step: LABA will be discontinued. The ICS is continued. Second step: medium to high daily ICS dose is reduced to low daily dose. Third step: The low ICS dose will be stopped. Before each reduction, saline challenge will be performed. Asthma diary is kept throughout the study and the subjects will be provided a direct telephone number to a respiratory physician during all hours of day.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kuopio University Hospital
• Treatments: Budesonide, Formoterol Fumarate Drug Combination; Fluticasone-Salmeterol Drug Combination

Criteria

Inclusion Criteria:70 adult (over 18 years) subjects with the following features

• doctor's diagnosis of asthma and right to special reimbursement from anti-asthma medication expenses according to Finnish Social Insurance Institute criteria (code 203 in the social insurance card)

• asthma diagnosis confirmed at least two years previously

• regular treatment with inhaled corticosteroids and long-acting beta-agonists for at least 6 months

• no changes in regular anti-asthma medication within 6 months

• asthma is well controlled (all conditions must be fulfilled):

• No courses of oral corticosteroids due to asthma within one year

• No hospital admissions due to asthma within one year

• Juniper's Asthma Control Questionnaire score equal or less than 0.75

Exclusion Criteria:

• the presence of another chronic respiratory disease in addition to asthma. Such diseases include moderate to severe polypotic chronic rhinosinusitis, chronic obstructive pulmonary disease, sarcoidosis, and cystic fibrosis

• presence of severe co-morbidity

• history of smoking more than 10 pack-years

• pregnancy