NCT06003049

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: RMW Testing · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	OnabotulinumtoxinA	BOTOX injection series
OTHER	Placebo	Placebo injection series

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-04-24
• Completion: 2024-07-10
• First posted: 2023-08-21
• Last updated: 2024-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study