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NCT04795323 · ClinicalTrials.gov registry record · Phase 2

Proof of Concept Study Assessing Technology-Assisted Respiratory Adherence Prototype Version 3 in Individuals With COPD

A Phase 2 study of Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 2
Development phase
5
Enrollment target
2
Study locations

NCT04795323 is a Phase 2 study of Pulmonary Disease, Chronic Obstructive that has completed, run by Boehringer Ingelheim. The registered enrollment target is 5 participants, below the 1,044-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT04795323, a Phase 2 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 2
Development phase
5 participants
Enrollment target
2
Study locations

Study 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 engagement with Technology-Assisted Respiratory Adherence prototype 3. The study's secondary aim is to assess whether there is an associated maintenance or increase in activities of daily living to support a positive benefit of Technology-Assisted Respiratory Adherence prototype 3 on breathlessness and whether there is an improvement in the physical activity experience of the patient.

Interventions

  • DEVICE TARA v3.1, only non-pharmacological self-management support
  • DEVICE TARA v3.2, both non-pharmacological and pharmacological self-management support

Study Locations (2)

North Carolina

  • Clinical Research of Gastonia - Gastonia

South Carolina

  • Lowcountry Lung and Critical Care - Charleston

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2021-04-08
Est. Completion 2022-03-12
Phase Phase 2

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT04795323

The ClinicalTrials.gov registry entry for NCT04795323 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,044-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (100% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 2 interventions - of which TARA v3.1, only non-pharmacological self-management support is the first listed.

NCT04795323 reports 2 study locations spanning 2 distinct geographic areas - top geographies include North Carolina, South Carolina.

Frequently Asked Questions

What is clinical trial NCT04795323 about?

NCT04795323 is a clinical study titled "Proof of Concept Study Assessing Technology-Assisted Respiratory Adherence Prototype Version 3 in Individuals With COPD". 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 engagement with Technology-Assisted Respiratory Adherence prototype 3. The study's secondary aim is t...

What is the current status of trial NCT04795323?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2021-04-08. Estimated completion is 2022-03-12.

What conditions does trial NCT04795323 study?

This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.

What interventions are being tested in trial NCT04795323?

The interventions under investigation include: TARA v3.1, only non-pharmacological self-management support (DEVICE), TARA v3.2, both non-pharmacological and pharmacological self-management support (DEVICE).

Who is sponsoring clinical trial NCT04795323?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04795323 being conducted?

This trial has 2 study locations across North Carolina, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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