Kent Town, Australia

Respiratory Clinical Trials Pty Ltd

Fibrosis

Idiopathic Pulmonary Fibrosis

Pulmonary Fibrosis

Interstitial Lung Diseases

Lung Diseases

Bronchiectasis

Treprostinil

Brensocatib

Nalbuphine

GLPG1690

Avalyn Pharma

Galapagos

Insmed

Trevi Therapeutics

United Therapeutics

condition

allSponsorName

gender

Male

Female

overallStatus

Recruiting

Not yet recruiting

Active, not recruiting

Enrolling by invitation

Completed

Terminated

Withdrawn

Suspended

Unknown

type

Interventional

Observational

Expanded Access

phase

Early Phase 1

Phase 1

Phase 2

Phase 3

Phase 4

Not Applicable

funderTypes

Industry

Other U.S. Federal agency

All others

ageGroup

Child (birth-17)

Adult (18-64)

Older Adult (65+)

This is an open-label extension study for participants who were previously enrolled in and completed an Avalyn Pharma Sponsored study with an inhaled antifibrotic, such as AP01. Eligible participants will have their final dose of drug at the end of study visit from the lead-in study and first AP-LTE-008 study visit on the same day.

All participants will receive 100 mg inhaled pirfenidone inhalation solution (AP01) taken twice daily using the eFlow Nebulizer System for until such a time that the drug is approved, the participant withdraws from the study, or the study is terminated.

New patients will be trained to use the nebuliser at the first treatment visit. All patients will use the eFlow nebuliser to administer AP01. Hands on training for use and cleaning of the eFlow nebuliser will be performed by site personnel with patients using the study specific instructions for use and quick reference guide provided. The first treatment for new patients will be overseen by clinic personnel.

A paper dosing diary will be used to monitor adherence along with returns of any unused investigational product.

An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)

Respiratory Clinical Trials Pty Ltd | Kent Town, Australia

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An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)

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