Trial record 9 of 538 for:    Open Studies | "Asthma"

Stepping Down of Asthma Medication in Controlled Asthma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Kuopio University Hospital
Sponsor:
Information provided by (Responsible Party):
Heikki Koskela, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT01961154
First received: October 9, 2013
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Asthma
Drug: Asthma medication reduction

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Stepping Down of Asthma Medication in Controlled Asthma

Resource links provided by NLM:


Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • Asthma exacerbation [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
    Possible asthma exacerbation secondary to asthma medication reduction


Secondary Outcome Measures:
  • The proportion of asthma patients able to reduce their medication [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]
    The number of participants who tolerated at least one step of medication reduction without exacerbation


Estimated Enrollment: 70
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Medication reduction
All participants undergo similar type of asthma medical reduction. Thus, there is only one arm.
Drug: Asthma medication reduction
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.
Other Name: Seretide, Symbicort

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01961154

Contacts
Contact: Heikki H Koskela, MD +358447172795 heikki.koskela@kuh.fi

Locations
Finland
Kuopio University Hospital Recruiting
Kuopio, KYS, Finland, 70029
Contact: Heikki O Koskela, MD    +358447172795    heikki.koskela@kuh.fi   
Sponsors and Collaborators
Kuopio University Hospital
  More Information

No publications provided

Responsible Party: Heikki Koskela, Respiratory Physician, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT01961154     History of Changes
Other Study ID Numbers: KUH5801124
Study First Received: October 9, 2013
Last Updated: October 11, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by Kuopio University Hospital:
Asthma
medication reduction
asthma exacerbation

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014