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Completed

NCT Number: NCT03321877

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lungemedicinsk Forskningsenhed

Copenhagen, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Change to dose of patient's regular medication

Drug

Dose reduction of the drug each patient was already taking

Primary outcomes

  1. Responsiveness to metacholine bronchial challenge

    Time frame: 8 weeks

    PD(20) if positive test

Secondary outcomes

  1. ACQ score

    Time frame: 8 weeks

    asthma control questionnaire

  2. miniAQLQ score

    Time frame: 8 weeks

    asthma quality of life score

  3. Pulmonary function tests

    Time frame: 8 weeks

    FEV1, FVC, reversibility to beta agonist

  4. FeNO

    Time frame: 8 weeks

    fraction of exhaled nitric oxide

  5. Sputum cell differentials

    Time frame: 8 weeks

    sputum neutrophil and eosinophil counts

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

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

Acronym: DOSIS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 26, 2017
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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