NCT04744090

Roflumilast as add-on Therapy in Early Cases of ARDS

Completed Phase 2 Last updated 4 April 2022

What this trial tests

Phase 2 trial testing Roflumilast in Respiratory Distress Syndrome, Adult in 76 participants. Completed in 1 January 2022.

Timeline

21 March 2021

Primary endpoint
30 December 2021

1 January 2022

Quick facts

Lead sponsor	Cairo University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	76
Start date	21 March 2021
Primary completion	30 December 2021
Estimated completion	1 January 2022
Sites	2 locations across Egypt

Drugs / interventions tested

• Roflumilast (ROFLUMILAST) — full drug profile →
• Placebo

Conditions studied

• Respiratory Distress Syndrome, Adult — all drugs for Respiratory Distress Syndrome, Adult →

Sponsor

Cairo University

Who can join

Adults 18 to 65, any sex, with Respiratory Distress Syndrome, Adult. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

* Mild cases of ARDS will be included in a two-arm protocol, to receive 500 mcg of roflumilast daily up to 28 days (FDA approved dose for COPD) plus standard of care versus standard of care alone.
* Approximately 76 hospitalized patients with ARDS will be enrolled in this study.
* Eligible patients will be randomized at ratio of (1:1) to receive either roflumilast plus standard of care or standard of care alone.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical Implication of Phosphodiesterase-4-Inhibition.
   Schick MA, Schlegel N. · · 2022 · cited 56× · PMID 35163131 · DOI 10.3390/ijms23031209