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

Exclusion Criteria

• •1. 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
• •2. 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)
• •3. Known allergy to BTX-A
• •4. Known history of pulmonary hypertension
• •5. Documented COPD exacerbation within 4 weeks of Baseline (Day 1)
• •6. Post-bronchodilator FEV1 value ≤30% of the predicted value at screening
• •7. Current smoker (e-cigarettes or cigarettes, cigars, pipe tobacco, vape)
• •8. Prior or current lung cancer
• •9. Post COVID symptoms resulting in breathing difficulties beyond pre-COVID COPD symptoms
• •10. Allergy to local anesthetics
• •11. History of botulism
• •12. Has an active pulmonary infection requiring systemic therapy within 14 days prior to the baseline visit
• •13. Known/documented medical history of clotting disorders
• •14. Pregnant or breastfeeding
• •15. Requires immediate admission to the hospital during screening that would render the participant unable to comply with the protocol
• •16. 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
• •17. 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
• •18. 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.
• •19. History of keloid formation after injury.
• •20. Treatment with another investigational drug or other investigational intervention within 2 weeks of study start and throughout study duration
• •21. Treatment with any botulinum toxin (BoNT) products within 6 months of the baseline visit.
• •22. 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.