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Not yet taking people in GermanyPhase 2

Tests an inhaled lung surfactant in people with idiopathic pulmonary fibrosis

Tests an inhaled surfactant against placebo in adults with lung scarring.

Key facts

Who runs it
Philipps-Universitaet Marburg
Where
Giessen and Munich, GermanySee the 2 sites
Registry title
Investigation of breathable surfactant agent in patients with idiopathic lung fibrosis
Status
Not yet recruiting
Phase
Phase 2
People taking part
20 people, planned
Started
1 Oct 2026
Expected to end
31 Mar 2028
Type of study
Interventional
Record updated
4 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with idiopathic pulmonary fibrosis (IPF) to test an inhaled surfactant, Alveofact®, against placebo.

Age
18 years or older
Sex
All sexes can join.
Disease stage
IPF according to International Consensus Guidelines. FVC above 75% predicted, TLCO above 40% predicted, capillary pO2 above 60 mm Hg at rest, and no need for extra oxygen at rest.
Earlier treatment
Not treated before, or treated with standard of care for more than 3 months. People not treated before can join only if they already failed on standard-of-care medication.

Main reasons for not taking part

  • Flare-up or breathing infection in the last four weeks
  • Known bronchial asthma
  • Pregnancy or breastfeeding
  • Emphysema over 15% of lung volume, or COPD with FEV1/FVC ratio below 70%
  • Cancer needing treatment, or life expectancy under 1 year

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

  • IPF according to International Consensus Guidelines
  • For women of childbearing potential: A negative result in highly sensitive pregnancy test. Willingness of women of childbearing potential (WOCBP) to use acceptable effective methods of contraception* during treatment and until treatment discontinuation
  • Forced Vital Capacity (FVC) > 75% predicted
  • Diffusion Capacity for CO (TLCO) > 40% predicted
  • Capillary pO2 > 60 mm Hg at rest
  • No need for supplemental oxygen at rest
  • Treatment-naive patients or patients treated with standard of care for more than 3 months. Treatment naive patients can only be included if they have previously failed on SOC medication. No standard of care medication will be withheld from participants of the study
  • Patient must be ≥ 18 years old
  • Signed written informed consent
  • Ability and willingness to comply with study procedures

Who cannot take part

  • Current / previous exacerbation / respiratory infection within the last four weeks
  • Concomitant emphysema > 15% of lung volume (by High Resolution Computed Tomography (HRCT))
  • Concomitant COPD with FEV1/FVC ratios < 70%
  • Concomitant malignant disease requiring therapy
  • History of alcohol or drug abuse in the past year
  • Hypersensitivity to the active substance or any of the other ingredients
  • Any other liver disease with elevated ART/ARS >3 times the upper normal limit (UNL)
  • Renal insufficiency (GFR < 50% predicted and/or Crea > 2mg/dl)
  • Any acute / chronic heart failure with ejection fraction of < 40%
  • Patients with known bronchial asthma
  • Simultaneous participation in another clinical trial with an experimental treatment
  • Assessment by the investigator that the patient should not participate in the study if the patient is unlikely to be able to comply with the study procedures, limitations and requirements
  • Pregnancy or breastfeeding
  • Estimated life expectancy of less than 1 year for any reason
  • Chronic liver cirrhosis > Child A

Where in Germany

  • Justus-Liebig-Universitaet GiessenGiessen, GermanyNot yet recruiting
  • Klinikum der Universitaet Muenchen AöRMunich, GermanyNot yet recruiting

About the trial

What the trial wants to find out

To evaluate the effect of inhalative Alveofact® on the Forced Vital Capacity of IPF patients after treatment compared to placebo in the same patients

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Proof-of-principle study of inhaled pulmonary surfactant in patients with Idiopathic Pulmonary Fibrosis (INSURF-IPF)
Plain-language title
Tests an inhaled lung surfactant in people with idiopathic pulmonary fibrosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
4 August 2026