Stepping Down of Asthma Medication in Controlled Asthma

NCT01961154 | Completed

• 1 other identifier: KUH5801124
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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. 1.To investigate whether airway responsiveness to hypertonic saline can predict the outcome of asthma treatment reduction in subjects with controlled asthma.
2. 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.
3. 3.Airway responsiveness to hypertonic saline can predict the outcome of asthma treatment reduction
4. 4.Most of the Finnish asthmatic patients use their medications with unnecessarily high doses

Conditions

Asthma

Keywords

Asthma; medication reduction; asthma exacerbation

Outcome Measures

Primary Outcomes (1)

• Asthma exacerbation

  Possible asthma exacerbation secondary to asthma medication reduction

  six weeks

Secondary Outcomes (1)

• The proportion of asthma patients able to reduce their medication

  18 weeks

Study Arms (1)

Medication reduction

OTHER

All participants undergo similar type of asthma medical reduction. Thus, there is only one arm.

Drug: Asthma medication reduction

Interventions

Asthma medication reduction DRUG

The asthma medications will be reduced in three steps up to total cessation of asthma drugs or up to asthma exacerbation. First step: Long-acting beta-agonist will be discontinued. The use of inhaled corticosteroids is continued, using the same dosage, preparation, and inhaler as before, for six weeks. Second step: medium to high daily inhaled corticosteroids dose is reduced to low daily dose, for six weeks. Third step: low inhaled corticosteroids dose will be stopped, for six weeks. Before each reduction, saline challenge will be performed.

Also known as: Seretide, Symbicort

Medication reduction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuopio University Hospital: lead

Study Sites (1)

Kuopio University Hospital

Kuopio, KYS, 70029, Finland

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug Combination; Budesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Formoterol Fumarate; Budesonide; Pregnenediones; Pregnenes; Pregnanes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Respiratory Physician

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 11, 2013
• Study Start: October 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 1, 2016

Record last verified: 2016-08

Locations

FI (1)