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AURA-IPF - Evaluation of Nintedanib Solution for Inhalation (AP02) in Participants with Idiopathic Pulmonary Fibrosis (IPF)

Clinical Trial | Foothills Medical Centre | Research | Study | Pulmonary Disorders

This study is open to adults aged 40 and older who have idiopathic pulmonary fibrosis (IPF). The purpose of the study is to determine if nintedanib solution for inhalation (AP02) is safe, tolerable, and effective for people with IPF.

The study involves 7 visits over a period of up to 16 weeks. There will be a screening period of up to 14 days, a 12-week treatment period, and a 2-week follow-up period. Participants will be randomly assigned to 1 of 3 treatment arms:
Group 1: study drug AP02 4mg (high dose) inhaled twice a day by mouth
Group 2: study drug AP02 2mg (low dose) inhaled twice a day by mouth
Group 3: placebo inhaled twice a day by mouth

There is a 63% change of receiving AP02 and a 37% chance of receiving placebo. The placebo will look like AP02 but will contain no active medicine.

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Conditions de participation

  • Sexe:

    Male, Female, Intersex

  • Âges admissibles:

    40 and up

Critères de participation

Inclusion Criteria:
You may be eligible to participate if you:
1. Are 40 years old or older at the time of signed informed consent
2. Have a diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
3. Are not on current treatment with nintedanib (Ofev) or pirfenidone (Esbriet) for at least 3 months or longer
Exclusion Criteria:
You may not be eligible to participate if you:
1. Are under the age of 40 years old
2. Are currently on treatment with nintedanib (Ofev) or pirfenidone (Esbriet)
3. Are a current smoker/vaper

Lieu de l'étude

University of Calgary
University of Calgary
Calgary, Alberta
Canada

Contactez l'équipe d'étude

Étude parrainée par
University of Calgary
Participants recherchés
Plus d'informations
ID de l'étude: REB25-1800