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RecruitingNCT05310669NASAUpdated Feb 5, 2026

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

An observational study in Fibrosis, Pulmonary, sponsored by University of Modena and Reggio Emilia. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by University of Modena and Reggio Emilia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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 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.

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.

02

Conditions studied

  • Fibrosis, Pulmonary

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Keywords

  • Inspiratory effort
  • Lung Damage
  • Fibrosis progression
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusione criteria

  • Age below 18
  • Pregnancy
  • Inability to sign informed consent
  • COPD
  • Neuromuscular diseases
  • Evidence of IPF acute exacerbation
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • DeviceNasal pressure assessment

    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).

05

What researchers measure

Primary outcomes

  1. Inspiratory effort

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

    Time frame: 2 hours.

Secondary outcomes

  1. Forced expiratory volume decline

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

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
  • Azienda Ospedaliero Universitaria Policlinico di Modena
    Modena, Italy
    • Roberto Tonelli · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05310669
Lead sponsor
University of Modena and Reggio Emilia
Responsible party
Roberto Tonelli (Principal investigator, University of Modena and Reggio Emilia) — Principal investigator
First posted
Apr 5, 2022
Start date
Jul 1, 2023
Primary completion
Jul 1, 2027 (estimated)
Completion
Jul 1, 2030 (estimated)
Last update
Feb 5, 2026

Study contacts

Roberto Tonelli, MD
Contact
roberto.tonelli@unimore.it
+390594225934
Alessandro Marchioni, MD
Contact
marchioni.alessandro@unimore.it
+390594225859

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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