Down-titration of Steroids in Patients With Difficult Asthma With no Bronchial Hyperreactivity (DOSIS)

Down-titration of Steroids in Patients With Difficult Asthma With no Bronchial Hyperreactivity: Severe Asthma or Simply Over-treatment?

An 8 week 'real-life' inhaled corticosteroid (ICS) dose reduction study in patients with severe asthma without evidence of bronchial hyperactivity.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Change to dose of patient's regular medication

Detailed Description

We aim to describe the proportion of patients with severe asthma, but without objective evidence of active disease, who can successfully be reduced in ICS dose for a period of 8 weeks. This is also intended as an exploration of the methodology and feasibility of step-down studies with this patient group, to act as a pilot for future projects.

This study enrolled patients from the SATS severe asthma study, in which they had undergone systematic investigation for comorbidities, triggers and barriers to good asthma control.

After baseline investigations, the patient's ICS dose is halved (or as close as possible to, but not below, 50%). Patients continued on the same inhaled steroid drug and device. Patients taking a combined ICS/LABA inhaler halve the dose of this, as per usual clinical practice. Other asthma medicaitons are continued unchanged.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Lungemedicinsk Forskningsenhed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Physician-diagnosed asthma for at least 6 months
• Fulfill ERS/ATS giudelines for severe asthma
• Stable dose of ICS for at least 4 weeks
• Able to carry out study procedures
• Negative metacholine provocation test at screening
• Negative reversibility to beta agonist at screening
• FeNO under 50 ppb

Exclusion Criteria:

• Treatment with prednisolone, methotrexate, ciclosporin, omalizumab or nucala in the last 6 months
• FEV1 under 70% of predicted
• Acute upper or lower airway infection requiring antibiotics in the last 4 weeks
• Exacerbation of asthma requiring prednisolone in the last 6 months
• Current smoking
• Pregnancy or breastfeeding
• Other clinically significant lung disease
• Current participation in another interventional study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Study group; All included patients underwent dose reduction.	Drug: Change to dose of patient's regular medication; Dose reduction of the drug each patient was already taking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responsiveness to metacholine bronchial challenge	PD(20) if positive test	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACQ score	asthma control questionnaire	8 weeks
miniAQLQ score	asthma quality of life score	8 weeks
Pulmonary function tests	FEV1, FVC, reversibility to beta agonist	8 weeks
FeNO	fraction of exhaled nitric oxide	8 weeks
Sputum cell differentials	sputum neutrophil and eosinophil counts	8 weeks

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2016
• Primary Completion (ACTUAL): May 31, 2017
• Study Completion (ACTUAL): May 31, 2017

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (ACTUAL): October 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 23, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Bronchial Hyperreactivity
• Other Study ID Numbers: 55855

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No