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临床试验/NCT01961154
NCT01961154已完成不适用

Stepping Down of Asthma Medication in Controlled Asthma

Kuopio University Hospital1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
Asthma exacerbation

研究概览

简要总结

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.

详细描述

Stepping down of asthma medication in controlled asthma

Principal investigator:

Heikki Koskela, MD. Kuopio University Hospital, Unit for Medicine and Clinical Research, Division of Pulmonary Medicine

The study will be started during the year 2012 and will continue for 36 months.

Background

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Medication reduction

Other

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

干预措施: Asthma medication reduction (Drug)

结局指标

主要结局

Asthma exacerbation

时间窗: six weeks

Possible asthma exacerbation secondary to asthma medication reduction

次要结局

  • The proportion of asthma patients able to reduce their medication(18 weeks)

研究者

发起方
Kuopio University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Heikki Koskela

Respiratory Physician

Kuopio University Hospital

研究点 (1)

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