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)

RMW Testing1 site in 1 country40 target enrollmentOctober 1, 2023

ConditionsCOPD

InterventionsOnabotulinumtoxinA Placebo

DrugsOnabotulinumtoxinA

Overview

Phase: Phase 2
Intervention: OnabotulinumtoxinA
Conditions: COPD
Sponsor: RMW Testing
Enrollment: 40
Locations: 1
Primary Endpoint: CAT (Average)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 1, 2023

End Date

July 10, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

RMW Testing

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 years of age or older
•History of moderate COPD as diagnosed by a physician
•FEV1 /FVC Ratio \< 0.7 with Post-Bronchodilator FEV1 ≥50% of predicted value at Screening
•Modified Medical Research Council (mMRC) Dyspnea Scale score of Grade 2 or 3 (Appendix B) at Screening
•CAT score of 12-20 (Appendix C) measured at Screening and confirmed at Baseline
•Ability to consent
•Ability to receive subcutaneous injections along the spine/back in the T-1 \> T-5 region
•Females of reproductive potential must have a negative pregnancy test at screening and use of highly effective contraception method (refer to section 12.3.9) for 4 weeks after study drug administration. Women are generally considered to be of reproductive potential if a non-menopausal female has not had a hysterectomy, bilateral oophorectomy, or medically documented ovarian failure.
•Males of reproductive potential must use condoms with spermicide or other methods to ensure effective contraception with partner for 4 weeks after study drug administration. Men are generally considered to be of reproductive potential if they can produce sperm.

Exclusion Criteria

•Any medical condition that may put the participant at increased risk with exposure to botulinum toxin type A (BTX-A), including, but not limited to diagnoses of myasthenia gravis (MG), Eaton-Lambert syndrome, amyotrophic lateral sclerosis, multiple sclerosis, or any other significant disease that might interfere with neuromuscular function
•Treatment of study target treatment area using acupuncture, transcutaneous electrical stimulation (TENS), cranial traction or injection of anesthetics/steroids within 4 weeks prior to the screening visit (oral or inhaled steroids are allowed)
•Known allergy to BTX-A
•Known history of pulmonary hypertension
•Documented COPD exacerbation within 4 weeks of Baseline (Day 1)
•Post-bronchodilator FEV1 value ≤30% of the predicted value at screening
•Current smoker (e-cigarettes or cigarettes, cigars, pipe tobacco, vape)
•Prior or current lung cancer
•Post COVID symptoms resulting in breathing difficulties beyond pre-COVID COPD symptoms
•Allergy to local anesthetics

Arms & Interventions

Treatment Arm

OnabotulinumtoxinA

Intervention: OnabotulinumtoxinA

Placebo Arm

Normal saline

Intervention: Placebo

Outcomes

Primary Outcomes

CAT (Average)

Time Frame: 28 days

The COPD Assessment Test (CAT) is assessed to capture the health status. The total score ranges from 0 to 40 points. Average change in CAT score over 28 days between treatment arms with a higher scores indicating a more significant change in health status.