Status:
COMPLETED
Proof of Concept Study Assessing Technology-Assisted Respiratory Adherence Prototype Version 3 in Individuals With COPD
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
The study's primary aim is to assess whether there is a clinically significant reduction in breathlessness in symptomatic individuals with chronic obstructive respiratory disease (IwCOPD) following en...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Individuals with COPD (IwCOPD)
- Male or females
- Age ≥ 40 years
- Current or ex-smokers
- Modified Medical Research Council Dyspnoea Scale (mMRC) score ≥ 2 (i.e. evidence of activity-related breathlessness)
- Patients must have a prescription for either Spiriva Respimat or
- Stiolto Respimat as per one of the below scenarios:
- Participants must have a new prescription for either Spiriva Respimat or Stiolto Respimat (this could include a patient who has never received a maintenance bronchodilator for treatment before, or a patient who was previously on an alternative maintenance bronchodilator who is being switched to Spiriva Respimat or Stiolto Respimat to help with their COPD management).
- Participants currently on Spiriva Respimat or Stiolto Respimat who could benefit from engagement with Technology-Assisted Respiratory Adherence prototype version 3 (after discussion with their physician).
- Participants must be on a short-acting bronchodilator ("rescue medication")
- Participants must be willing to use the study specific activity tracker (Reemo device) and be willing to complete all data collection requirements (within Technology-Assisted Respiratory Adherence prototype version 3) plus on-line questionnaires plus possible phone interview)
- Fluency in written English
- Access to a Smartphone with updated browsers installed (or willing to download up-to-date version for the study), and daily home access to internet
- Need to have personal e-mail account that is used daily
- Exclusion criteria:
- Patients with asthma
- Patients with confirmed, suspected or recovered SARS-CoV-2 infection or if the patient had household or other contact with an individual with confirmed SARS-CoV-2 infection.
- Patient with a worsening COPD episode requiring medical intervention within 4 weeks of enrolment
- Patients who have completed a pulmonary rehabilitation (PR) or self-management program in the 3 months prior to enrolment or patients who are currently in a PR program
- Patients prescribed inhaled COPD medications other than Spiriva Respimat plus albuterol or Stiolto Respimat plus albuterol
- Patients with any contraindications for participating in the study (after discussion with their physician).
- Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s), or receiving other investigational treatment(s)
- Women who are pregnant, nursing, or who plan to become pregnant while in the study
- Any self-reported medical or neuro-cognitive condition that would limit the ability of the participant to consent
Exclusion
Key Trial Info
Start Date :
April 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04795323
Start Date
April 8 2021
End Date
March 12 2022
Last Update
December 21 2023
Active Locations (2)
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1
Clinical Research of Gastonia
Gastonia, North Carolina, United States, 28054
2
Lowcountry Lung and Critical Care
Charleston, South Carolina, United States, 29406