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

Asthma Clinical Trial

— DOSIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03321877
• Other study ID #: 55855
• Status: Completed
• Phase: N/A
• First received: October 23, 2017
• Last updated: October 23, 2017
• Start date: October 1, 2016
• Est. completion date: May 31, 2017

Study information

• Verified date: October 2017
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Bronchial Hyperreactivity

Intervention

Drug:
• Change to dose of patient's regular medication
Dose reduction of the drug each patient was already taking

Locations

Country	Name	City	State
Denmark	Lungemedicinsk Forskningsenhed	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responsiveness to metacholine bronchial challenge	PD(20) if positive test	8 weeks
Secondary	ACQ score	asthma control questionnaire	8 weeks
Secondary	miniAQLQ score	asthma quality of life score	8 weeks
Secondary	Pulmonary function tests	FEV1, FVC, reversibility to beta agonist	8 weeks
Secondary	FeNO	fraction of exhaled nitric oxide	8 weeks
Secondary	Sputum cell differentials	sputum neutrophil and eosinophil counts	8 weeks