NCT03321877

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

October 23, 2017

Last Update Submit

October 23, 2017

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Responsiveness to metacholine bronchial challenge

    PD(20) if positive test

    8 weeks

Secondary Outcomes (5)

  • ACQ score

    8 weeks

  • miniAQLQ score

    8 weeks

  • Pulmonary function tests

    8 weeks

  • FeNO

    8 weeks

  • Sputum cell differentials

    8 weeks

Study Arms (1)

Study group

EXPERIMENTAL

All included patients underwent dose reduction.

Drug: Change to dose of patient's regular medication

Interventions

Change to dose of patient's regular medicationDRUG

Dose reduction of the drug each patient was already taking

Study group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lungemedicinsk Forskningsenhed

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research doctor

Study Record Dates

First Submitted

October 23, 2017

First Posted

October 26, 2017

Study Start

October 1, 2016

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)