NCT04982809

Brief Summary

This was a 3 months prospective, open label, and parallel study to test the efficacy of 3 different corticosteroids in the management of interstitial lung diseases. Followed by a pharmacoeconomic analysis to find which regimen (betamethasone, dexamethasone or prednisolone) is the most cost-effective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 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

Study Start

First participant enrolled

July 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

1.7 years

First QC Date

July 19, 2021

Last Update Submit

July 23, 2021

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

  • Krebs von den Lungen - 6 (KL-6)

    a high molecular weight mucin-like glycoprotein expressed on cell surface of alveolar epithelial cells. Elevated levels of KL-6 occur in ILDs and it is recently widely accepted as a biomarker for diagnosis and prognosis of ILDs. Measured as (U/ml) using ELISA

    3 months

Secondary Outcomes (5)

  • Respiratory Function Assessment; FEV1

    3 months

  • Respiratory Function Assessment; FVC

    3 months

  • Respiratory Function Assessment; FEV/FVC Ratio

    3 months

  • Respiratory Function Assessment; 6MWD

    3 months

  • Respiratory Function Assessment; % O2 desaturation

    3 months

Study Arms (3)

Betamethasone group

ACTIVE COMPARATOR
Drug: Betamethasone, Dexamethasone, Prednisolone

Dexamethasone group

ACTIVE COMPARATOR
Drug: Betamethasone, Dexamethasone, Prednisolone

Prednisolone group

ACTIVE COMPARATOR
Drug: Betamethasone, Dexamethasone, Prednisolone

Interventions

Betamethasone, Dexamethasone, PrednisoloneDRUG

Corticosteroids

Betamethasone groupDexamethasone groupPrednisolone group

Eligibility Criteria

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

You may qualify if:

  • Patients with ILD (hypersensitivity pneumonitis) with age between18 and 65 years old.
  • Symptoms including dry cough and shortness of breath.
  • Significant decrease in pulmonary function (desaturation by 4% after 6-minute walk distance), where the patients were no more controlled on their prednisolone maintenance therapy (up to 10 mg/day).
  • Chest CT showing ground glass opacity and band of shadow.

You may not qualify if:

  • Patients with any other organ affliction (heart failure (ejection fraction 40-50%), renal failure (decrease in glomerular filtration rate \> 75%), or liver cirrhosis (transient elastography liver stiffness measurements 12.5-75.5 kPa)).
  • Active infection.
  • Patients on other immunosuppressive medications (e.g., cyclophosphamide) and anti-fibrotic (e.g., interferon, pirfenidone, endothelin-1 antagonist and tumor necrosis factor α modulator).
  • History of pulmonary embolism (corticosteroids' use increase the risk of recurrence of pulmonary embolism).
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Pharmacy Cairo University

Cairo, 12411, Egypt

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

BetamethasoneDexamethasonePrednisolone

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

July 19, 2021

First Posted

July 29, 2021

Study Start

July 1, 2018

Primary Completion

March 15, 2020

Study Completion

March 15, 2020

Last Updated

July 29, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)