Status:
COMPLETED
A Study to Evaluate Safety and Efficacy of BOTOX in Adults With Moderate COPD
Lead Sponsor:
RMW Testing
Conditions:
COPD
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 C...
Eligibility Criteria
Inclusion
- 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
- 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
- History of botulism
- Has an active pulmonary infection requiring systemic therapy within 14 days prior to the baseline visit
- Known/documented medical history of clotting disorders
- Pregnant or breastfeeding
- Requires immediate admission to the hospital during screening that would render the participant unable to comply with the protocol
- Any serious medical condition, such as kidney, liver, or cardiac disease, asthma, angioedema, bleeding disorder, malignancy, seizure, neutropenia, AIDS, that in the judgement of the Investigator could confound study assessments
- Any condition (physical, mental, or social), occupational reason or other responsibility that, in the judgment of the Investigator, would jeopardize the safety or rights of the study participant, or render the participant unable to comply with the protocol, including participant's return for follow-up visits on schedule
- Any chronic conditions which may cause diffusion of excess of Substance P in the cerebrospinal fluid (CSF), including but not limited to diabetes, chronic kidney failure, cirrhosis, pancreatitis, osteoporosis, ongoing clinical depression, migraines and fibromyalgia, that would compromise the participant's safety as determined by the Investigator.
- History of keloid formation after injury.
- Treatment with another investigational drug or other investigational intervention within 2 weeks of study start and throughout study duration
- Treatment with any botulinum toxin (BoNT) products within 6 months of the baseline visit.
- Any abnormal laboratory value greater than 3 times upper limit of normal (ULN) for albumin, total protein, alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), and bilirubin), and 5 times the upper limit of normal (ULN) for all other lab values.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06003049
Start Date
October 1 2023
End Date
July 10 2024
Last Update
July 17 2024
Active Locations (1)
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1
Tranquil Clinical Research
Webster, Texas, United States, 77598