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

NCT06061679 | Unknown

• 1 other identifier: 5432
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• The primary aim of the present study is to assess the effect on inhaler adherence to the Omron C28P

  The primary aim of the present study is to assess the effect on inhaler adherence to the Omron C28P, assessed by means of the Test of Adherence to Inhalers (TAI) questionnaire

  24 weeks

• The co-primary aim of the present study is to assess the effect on disease control of switching patients from their portable inhalers (either pMDIs or DPIs) to the Omron C28P

  The co-primary aim of the present study is to assess the effect on disease control of switching patients from their portable inhalers (either pMDIs or DPIs) to the Omron C28P assessed by means of the COPD Assessment Test (CAT)

  24 weeks

Study Arms (1)

Omron C28P cohort

EXPERIMENTAL

Patients diagnosed with COPD using the study device (OMRONC28P) for 24 weeks.

Device: Omron C28P nebuliser

Interventions

Omron C28P nebuliser DEVICE

switch from portable inhalers to the Omron C28P nebuliser

Omron C28P cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD patients treated by inhaled bronchodilators, corticosteroids or their combinations delivered by inhaler devices
• COPD patients not adherent (TAI ≤ 45) to recommended therapy
• COPD patients with a CAT score ≥18.
• Must be capable of giving informed consent to participate, and available to comply with the requirements and procedures foreseen by the study protocol.

You may not qualify if:

• COPD patients with history of recent (\< 4 weeks) upper respiratory tract infections and/or airways exacerbations
• patients with recent (\< 2 months) pulmonary surgery or any active diseases that, in the judgement of the investigator, may interfere with the study protocol.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• University of Florence, UNIFI University of Florence, Florence, Italy Florence: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Matteo Bonini, Professor

CONTACT

0630157724; matteo.bonini@policlinicogemelli.it

Stefania Cortese, Dr

CONTACT

0630157724; stefania.cortese@guest.policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Open, single-arm, real-life, prospective study

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 29, 2023
• Study Start: November 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: January 1, 2025
• Last Updated: September 29, 2023

Record last verified: 2023-09