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A Study to Evaluate Safety and Efficacy of BOTOX in Adults With Moderate COPD

COPD Clinical Trial

Official title:
An Investigator-Initiated, Single Center, Prospective, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety and Efficacy of OnabotulinumtoxinA (BOTOX®) in Adults With Moderate Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Summary

The aim of this clinical trial to determine the safety and effectiveness of treating the COPD symptoms with subcutaneous BOTOX injections in participants with moderate COPD.

Clinical Trial Description

This is a prospective, double-blind, randomized, placebo-controlled, investigator-initiated clinical trial to assess the safety, tolerability, and efficacy using an approved drug, BOTOX, in moderate COPD participants. Forty participants with moderate COPD, defined as mMRC Dyspnea Scale scores of grades 2 or 3 and CAT scores of 12 to 20, will be included. If eligibility criteria are met, subjects will be randomized to either the treatment arm (BOTOX) or placebo, treated on day one and observed for 90 days for safety and efficacy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06003049
Study type Interventional
Source RMW Testing
Contact
Status Active, not recruiting
Phase Phase 2
Start date October 1, 2023
Completion date July 12, 2024
View Details
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