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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03321877
Other study ID # 55855
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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