Last reviewed · How we verify
NCT04497090
Adaptive Non-invasive Ventilation to Abolish Tidal Flow Limitation
NA trial testing fixed-EPAP in Pulmonary Disease, Chronic Obstructive in 12 participants. Completed in 15 May 2018.
15 May 2018
Quick facts
| Lead sponsor | Politecnico di Milano |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 12 |
| Start date | 23 October 2014 |
| Primary completion | 15 May 2018 |
| Estimated completion | 15 May 2018 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- fixed-EPAP
- auto-EPAP
Conditions studied
- Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →
- Hypercapnia — all drugs for Hypercapnia →
- Ventilator Lung — all drugs for Ventilator Lung →
Sponsor
Politecnico di Milano
Who can join
Adults 18 to 84, any sex, with Pulmonary Disease, Chronic Obstructive or Hypercapnia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aimed to evaluate the effects of a novel automatic non-invasive ventilation (NIV) mode that continuously adjusts expiratory positive airway pressure (EPAP) to the lowest value that abolishes tidal expiratory flow limitation. The investigators conducted a prospective, randomized, cross-over study on stable chronic obstructive pulmonary disease (COPD) patients. Patients were studied in the hospital during two non-consecutive nights while using either fixed or adaptive EPAP. The primary outcome was the transcutaneous partial pressure of carbon dioxide. Secondary outcomes were: oxygen saturation, breathing pattern, oscillatory mechanics, patient-ventilation asynchronies, sleep quality and sleep-related respiratory events.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effect of nocturnal EPAP titration to abolish tidal expiratory flow limitation in COPD patients with chronic hypercapnia: a randomized, cross-over pilot study.
Zannin E, Milesi I, Porta R, Cacciatore S, et al · · 2020 · cited 7× · PMID 33208164 · DOI 10.1186/s12931-020-01567-x
Verify or expand the search:
- PubMed search for NCT04497090
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04497090 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Politecnico di Milano
- Last refreshed: 4 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04497090.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing