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Fibrosis, PulmonaryNASANCT05310669

Inspiratory Effort Assessed Through Nasal Pressure Measurement in Patients With Idiopathic Pulmonary Fibrosis

An observational study of Fibrosis, Pulmonary, run by University of Modena and Reggio Emilia at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Idiopathic Pulmonary Fibrosis (IPF) is a fibrosing progressive interstitial lung disease with unknown etiology, with a median survival of 3 years since first diagnosis. The typical radiologic pattern of the disease is usual interstitial pneumonia (UIP) defined by basal and peripheral (subpleural) predominance and a… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fibrosis, Pulmonary
What is being tested?
Nasal pressure assessment
Type of treatment
Medical device
How many people
100 participants
Where
1 siteItaly
Study dates
1 Jul 2023to 1 Jul 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients admitted to the Center for Rare diseases of Azienda Ospedaliero-Universitaria Policlinico di Modena, Italy

Who may be able to join

  • Patients treated in Center for Rare diseases of Azienda Ospedaliero-Universitaria Policlinico di Modena will be considered eligible if satisfying the following inclusion criteria:
  • Patient with IPF and UIP pattern
  • Need for radiological evaluation through HRCT
  • Exclusione criteria
  • Age below 18
  • Pregnancy
Show all 10Show fewer
  • Inability to sign informed consent
  • COPD
  • Neuromuscular diseases
  • Evidence of IPF acute exacerbation

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Roberto Tonelli, MD contact

+390594225934

roberto.tonelli@unimore.it

Alessandro Marchioni, MD contact

+390594225859

marchioni.alessandro@unimore.it

Italy1 site, 1 recruiting
  • Azienda Ospedaliero Universitaria Policlinico di Modena

    Modena

    Roberto Tonelli

    Recruiting

Other trials in Italy

About this study

Idiopathic Pulmonary Fibrosis (IPF) is a fibrosing progressive interstitial lung disease with unknown etiology, with a median survival of 3 years since first diagnosis. The typical radiologic pattern of the disease is usual interstitial pneumonia (UIP) defined by basal and peripheral (subpleural) predominance and a typical cystic degeneration of lung parenchyma (honeycombing), interstitial fibrotic thickening and traction bronchiectasis. Despite the recent introduction of two antifibrotic treatments (Pirfenidone and Nintendanib) which proved to be successful in slowing the decline of pulmonary function in patients with IPF, a benefit of these therapies on average survival remains yet to be demonstrated.

A significant part of patients affected by IPF die due to progressive worsening of respiratory failure, often accelerated by the insurgence of acute events, like acute exacerbations. Processes leading to the development and progression of IPF are not yet completely understood. We might hypothesize a regenerative deficit in the lungs of subjects affected, due to a dysregulation of repair mechanism in response to repeated damage (inflammatory, mechanics, infectious, chemical) to the alveolar and vascular epithelium. Moreover, mechanism of damage caused by aging in tissues, with a dysfunction in resident stem cell, might contribute to progression. Patients with IPF undergo mechanical alterations of respiratory system due to progressive restrictive deficit caused by reduction in total lung capacity. This functional alteration generates an ineffective and superficial ventilation due to the waste of the majority inspiratory effort spent in ventilating dead anatomical space. When physical effort occurs, the increased ventilatory necessity and the inability to compensate due to functional impairment leads to increased inspiratory effort and subsequent increase in negative intrathoracic pressure. Recent studies have demonstrated how exerting a pressure (for example when the patient is mechanically ventilated) on lung tissue of subjects with IPF and UIP pattern can generate damage due to unfavorable mechanism of mechanotransduction caused by the pathological behavior of fibrotic lung (''squishy ball lung''). Studies investigating inspiratory effort during spontaneous breathing and respiratory failure highlighted how negative values of intrathoracic pressure might induce self induced lung injury.

Read more

Respiratory effort can be quantified measuring esophageal pressure through a pressure transducer inserted with a nasogastric tube in the inferior third part of the esophagus. Measuring esophageal pressure is a precise and accurate way of quantifying inspiratory effort, however its use in daily clinical practice is limited by invasiveness of the maneuver, high cost and need for specific clinical training. Physiological studies show that nasal pressure measured at the entrance of the nostril might correlate with esophageal pressure and therefore estimate inspiratory effort of the patient in a noninvasive way.

The goal of our study is to evaluate the role of respiratory effort during spontaneous breathing as a potential source of mechanical damage (hence favoring disease progression) in subjects with IPF and UIP pattern. The study aims to identify patient with an unfavorable mechanical phenotype defined by the simultaneous presence of UIP pattern and elevated inspiratory effort after physical activity.

Being tested
Nasal pressure assessment
Keywords
Inspiratory effort, Lung Damage, Fibrosis progression
Medical subject headings
Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nasal pressure assessmentDevice

    Once the patient is enrolled nasal pressure will be measured through a dedicated pressure line located at the nostril entrance and connected to a dedicated pressure transducer (OptiVentTM, SIDAM, Mirandola, Italy). Measured nasal pressure will be the result of the variation between inspiratory and expiratory pressure (DeltaPnose).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inspiratory effort

    Quantification of inspiratory effort through nasal pressure before and after physical activity will be therefore considered as primary exploratory outcome.

    Measured: 2 hours.

Secondary outcomes (1)
  1. Forced expiratory volume decline

    Change in forced expiratory volume at 6 months will be correlated with values of respiratory effort

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2022
  2. Study start1 Jul 2023
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Jul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05310669
Sponsor's protocol ID
UModenaReggio16
Acronym
NASA
Status last verified
Feb 2026
First submitted
25 Mar 2022
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Fibrosis, Pulmonary, run by University of Modena and Reggio Emilia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Roberto Tonelli, MD (+390594225934, roberto.tonelli@unimore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inspiratory effort (time frame: 2 hours.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.

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