Meta description: A COPD trial tests a pulmonary rehabilitation device with inspiratory muscle training against a placebo module as part of a rehabilitation program. Not yet recruiting; sponsor Universidade do Estado do Pará.
Publication date context February 19, 2026 at 14:54:30 UTC provides a time stamp for readers tracking device based rehabilitation studies. The report is written for clinical quality and regulatory teams evaluating device interventions in chronic obstructive pulmonary disease.
In this article we summarize a trial record from ClinicalTrials.gov that describes two arms in a pulmonary rehabilitation program. The comparison aims to isolate the impact of inspiratory muscle training delivered by a device within standard rehab.
What changed
The record describes a COPD device trial that adds inspiratory muscle training to standard pulmonary rehabilitation. The active arm uses the device with inspiratory training. The comparator uses a placebo inspiratory training device during rehabilitation. The sponsor is Universidade do Estado do Pará. The trial is not yet recruiting. The official registry is linked below.
Interventions tested
Active intervention combines pulmonary rehabilitation with inspiratory muscle training delivered by a device. The comparator uses pulmonary rehabilitation with a placebo training module. Both arms reflect standard rehabilitation enhanced by a device based training component.
Trial status and sponsor
Not yet recruiting according to the registry. Sponsor Universidade do Estado do Pará. Trial identifier NCT07415746. The ClinicalTrials.gov page provides the official record for enrollment and intervention details.
How is the trial designed
The description indicates a two arm design within a pulmonary rehabilitation program. The goal is to evaluate the added value of inspiratory muscle training. No detailed methods are provided in the source text. Readers should consult the registry for full design specifics.
Regulatory context for device based inspiratory training in rehabilitation
The description uses language aligned with device regulation and Annex XIV style. It presents intended use and performance elements without implying regulatory clearance. Statements come from the sponsor or registry and relate to research rather than a cleared medical device product.
What are the clinical and developer implications
Clinical teams may watch this trial for future evidence on integrating inspiratory muscle training into COPD rehab. Device developers should note the need for clear intended use and performance claims in registry records. If a future regulatory submission occurs, it will require defined use, performance data, and safety information per MDR Annex XIV. The registry link provides ongoing updates.
- 1 What condition is studied?
The trial focuses on pulmonary disease and chronic obstructive pulmonary disease in a rehabilitation setting. - 2 What interventions are tested?
A device driven pulmonary rehabilitation program is tested with active inspiratory training and a placebo inspiratory module for comparison. - 3 Who sponsors the study?
Universidade do Estado do Pará is listed as sponsor. - 4 What is the status?
Not yet recruiting at the time of listing. - 5 Where can I find official information?
The registry link to ClinicalTrials.gov is provided in the article.
Conclusion
The registry description outlines a device based pulmonary rehabilitation trial with inspiratory muscle training in COPD. The status not yet recruiting indicates early stage monitoring. Readers should track the official registry for updates on results safety and regulatory implications for device developers and clinical practice.
Disclaimer
This article is intended for professionals. It is not legal advice. For regulatory questions consult MDR Annex XIV and a qualified adviser.
Announcement line
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07415746?term=medical+device