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Impact of Switching COPD Patients From Inhaler Devices to the Omron C28P Nebuliser.

NCT06061679 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2023-09-29

No results posted yet for this study

Summary

The cornerstone of COPD therapy is based on the use of inhalation drugs. The correct use of devices is crucial; a suboptimal use technique is the cause of a possible clinical deterioration with a consequent increase in exacerbations and healthcare expenditure. Inhalation of drugs by nebulizer, in specific populations of patients who have shown poor adherence to inhalation therapy and poor symptomatological control, could be a more advantageous therapeutic strategy than pMDIs or DPIs, not requiring coordination at the time of delivery and not requiring an effective inspiratory effort.

The objective of this study is to evaluate the effects of the transition from portable inhalers (pMDIs or DPIs) to an innovative prototype Omron C28P nebulizer, measured primarily as changes in treatment adhesion and respiratory symptoms. The sudy design is open, single-arm, real-life, prospective study conducted in two tertiary level respiratory centers in Italy, with assessments conducted on the occasion of patients' visits to their doctor.

Conditions

  • COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection

Interventions

DEVICE

Omron C28P nebuliser

switch from portable inhalers to the Omron C28P nebuliser

Sponsors & Collaborators

  • University of Florence, UNIFI University of Florence, Florence, Italy Florence

    collaborator UNKNOWN

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2024-04-30
Completion
2025-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06061679 on ClinicalTrials.gov