Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients
A Clinical Study on Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients
The goal of this observational study is to learn about the inspiratory flow rate capability in patients with pulmonary fibrosis (IPF or PPF) when using inhaler devices with different resistances. The main questions it aims to answer are:
What is the peak inspiratory flow rate (PIFR) that patients with pulmonary fibrosis can achieve through a medium-resistance inhaler device?
What is the peak inspiratory flow rate (PIFR) that patients with pulmonary fibrosis can achieve through a high-resistance inhaler device?
What is the inspiratory time (EIT) for each resistance level?
Participants will use a portable device called In-Check™ DIAL G16, which simulates the resistance of different dry powder inhalers. Each participant will perform two breathing tests at a medium-resistance setting and two breathing tests at a high-resistance setting, with a 2-minute rest between settings. The device measures how fast air is breathed in and how long each breath lasts.
This study will enroll 60 patients diagnosed with IPF or PPF at Shanghai Pulmonary Hospital. Participants will be involved for approximately 30 to 60 minutes, including training on how to use the device and the breathing tests. The study involves no drugs or invasive procedures.
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Jiuwu Bai
- Numero di telefono: +86 13651602925
- Email: yv59@163.com
Luoghi di studio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Cina, 200433
- Reclutamento
- Shanghai Pulmonary Hospital
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Contatto:
- Jiuwu Bai
- Numero di telefono: +86 13651602925
- Email: yv59@163.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Age 18-80 years (inclusive), either sex.
- Diagnosis of pulmonary fibrosis (IPF or PPF) according to the ATS/ERS/JRS/ALAT 2022 guidelines (with traceable diagnostic evidence such as medical records, confirmed by a radiologist).
- Forced vital capacity (FVC) ≥ 45% of predicted normal value within 2 months before screening.
- Diffusing capacity for carbon monoxide (DLCO) > 25% of predicted normal value within 2 months before screening.
- Voluntary participation with written informed consent.
Exclusion Criteria:
- Patients with impaired consciousness, dementia, or various psychiatric disorders.
- Patients unable to operate the inspiratory flow measurement device as instructed by the investigator.
- Patients with major diseases or conditions other than the IPF under study that, in the investigator's judgment, may put the patient at risk by participating in the trial.
- Any participant deemed unsuitable for enrollment by the investigator.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Pulmonary Fibrosis Patients
Patients aged 18-80 years with a diagnosis of idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) according to the ATS/ERS/JRS/ALAT 2022 guidelines.
Participants will perform inspiratory flow tests using the In-Check™ DIAL G16 device at both medium-resistance and high-resistance settings.
No investigational drug or intervention is administered.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Peak Inspiratory Flow Rate (PIFR) at Medium Device Resistance
Lasso di tempo: Single visit (approximately 30-60 minutes)
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Peak inspiratory flow rate (PIFR, L/min) will be measured using the In-Check™ DIAL G16 device at the medium-resistance setting.
Each participant will perform two breathing tests at this setting.
The mean PIFR of the two valid measurements will be recorded.
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Single visit (approximately 30-60 minutes)
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Peak Inspiratory Flow Rate (PIFR) at High Device Resistance
Lasso di tempo: Single visit (approximately 30-60 minutes)
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Peak inspiratory flow rate (PIFR, L/min) will be measured using the In-Check™ DIAL G16 device at the high-resistance setting.
Each participant will perform two breathing tests at this setting.
The mean PIFR of the two valid measurements will be recorded.
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Single visit (approximately 30-60 minutes)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Inspiratory Time (EIT) at Medium and High Device Resistances
Lasso di tempo: Single visit (approximately 30-60 minutes)
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Inspiratory time (EIT, seconds) will be measured using the In-Check™ DIAL G16 device at two resistance settings: medium resistance and high resistance.
Each participant will perform two breathing tests at each resistance setting.
The mean EIT of the two valid measurements at each resistance level will be recorded and compared between the two settings.
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Single visit (approximately 30-60 minutes)
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Collaboratori e investigatori
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SHXHH-PF-DY-01
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
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