NCT03610685

Brief Summary

The aim of the project is to study the persistence of inflammation after addition of an interleukin-5 (IL-5) blocker in severe eosinophilic asthma as a study of untreated pathways in these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for phase_4 asthma

Timeline
Completed

Started Oct 2018

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

First Submitted

Initial submission to the registry

March 27, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

October 19, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2020

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

March 27, 2018

Last Update Submit

March 4, 2020

Conditions

Asthma

Keywords

Severe asthmaMepolizumabIL5Steroid resistanceEosinophilic asthmaType 2 inflammation

Outcome Measures

Primary Outcomes (2)

  • Change in exhaled nitric oxide measured in parts per billion

    Measured at study visits using a Niox machine.

    Through study completion, an average 20 weeks.

  • Change in sputum differential cell counts measured in absolute cell count.

    Induced sputum

    Through study completion, an average 20 weeks

Other Outcomes (3)

  • Change in asthma control and quality of life questionnaires

    Through study completion, an average 20 weeks.

  • Change in visual asthma symptom scores

    Through study completion, an average 20 weeks

  • Oscillometry

    Through study completion, an average 20 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants will be given 2 weeks of placebo treatment. The placebo capsules will be taken once a day orally. The daily dose of placebo treatment will match the Prednisone dose for each participant.

Drug: Placebo oral capsule

Prednisolone

ACTIVE COMPARATOR

Participants will be given 2 weeks of prednisolone treatment. This is administered orally once a day. The daily dose is calculated according to 0.5mg/kg with a maximum dose of 40mg per day.

Drug: Prednisolone

Interventions

PrednisoloneDRUG

Given daily for 2 weeks

Prednisolone
Placebo oral capsuleDRUG

Given daily for 2 weeks

Also known as: Placebo
Placebo

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 and ≤ 80 years at consent.
  • Able and willing to provide written informed consent and to comply with the study protocol.
  • Severe asthma diagnosis confirmed after assessment by an asthma specialist.
  • Suitable for mepolizumab as per NICE/SMC Clinical Guidelines.

You may not qualify if:

  • Maintenance oral corticosteroid treatment within the past four weeks.
  • Acute exacerbation requiring oral corticosteroids in the four weeks prior to consent.
  • Other clinically significant medical disease or uncontrolled concomitant disease despite treatment that is likely, in the opinion of the investigator, to require a change in therapy or impact the ability to participate in the study or be significantly worsened by oral corticosteroids.
  • History of current alcohol, drug, or chemical abuse or past abuse that would impair or risk the subject's full participation in the study, in the opinion of the investigator.
  • Treatment with an investigational agent within 30 days of Visit 1 (or five half-lives of the investigational agent, whichever is longer).
  • Women of child-bearing potential who are pregnant, lactating, planning pregnancy during the study period or are unwilling to use a highly effective form of contraception.
  • Known hypersensitivity to prednisolone or its excipients.
  • Previous psychiatric adverse reactions to steroid therapy in the past.
  • Concomitant medication with systemic anti-fungals such as ketoconazole, retinoids, tetracycline, other systemic immunosuppressants e.g. ciclosporin, azathioprine, mycophenolate and live vaccines during the crossover trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asthma and copd research centre

Glasgow, G12 0YN, United Kingdom

Location

MeSH Terms

Conditions

AsthmaPulmonary Eosinophilia

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesHypereosinophilic SyndromeEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Rekha Chaudhuri, MD

    NHS Greater Glasgow and Clyde

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2018

First Posted

August 1, 2018

Study Start

October 19, 2018

Primary Completion

January 7, 2020

Study Completion

January 7, 2020

Last Updated

March 6, 2020

Record last verified: 2020-03

Locations

GB(1)