Triple therapy convenience by the use of one or multiple inhaler and digital support in Chronic Obstructive Pulmonary Disease

Recruiting

Conditions: Chronic obstructive pulmonary disease (COPD)
10038716

Registration Number: NL-OMON51328

Lead Sponsor: Franciscus Gasthuis & Vlietland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

• Clinical diagnosis of COPD for at least 1 year before the screening visit
• Aged 40 years and older
• An indication for triple therapy according to the investigator*s judgement
(following the GOLD guideline 2021(2)).
Could be step-up from dual therapy or currently receiving triple therapy (both
MITT and SITT).
• Owner of mobile device compatible with e-device app with access to internet
(Android or iOS)
• Willing to provide written informed consent
• Current or ex-smoker

Exclusion Criteria

• Inability to comply with study procedures or with study treatment
• Inability to speak and/or read Dutch
• Asthma as the predominant disease according to the investigator*s opinion, a
past history of asthma is allowed
• Use of e-health application for COPD in the past six months
• Patients with any other therapy that could interfere with the study drugs
(according to the investigator*s opinion)
• Use of nebulized bronchodilators, for example via pari boy
• Pregnant or lactating women and all women physiologically capable of becoming
pregnant unless they have highly effective contraceptive
• Patients mentally or legally incapacitated, or patients accommodated in an
establishment as a result of an official or judicial order
• Patients without the capability to complete the questionnaires

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Average adherence to inhalation therapy (expressed in a percentage, measured as<br /><br>the number of actuations registered by the e-device divided by the total dose)<br /><br>over 12 months of treatment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Changes in TAI questionnaire score, beclomethasone and/or formoterol<br /><br>accumulation profile in hair analysis and differences in clinical outcomes and<br /><br>Patient Reported Outcome Measures (PROM*s), such as the Clinical COPD<br /><br>Questionnaire (CCQ), number of exacerbations and Salbutamol use</p><br>