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

NCT06003049 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: COPD 101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• CAT (Average)

  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.

  28 days

Secondary Outcomes (6)

• CAT (Change in Units)

  28 days

• FEV1

  28 days

• FEV1/FVC

  28 days

• 6MWT

  28 days

• COPD Exacerbations

  90 days

Other Outcomes (5)

• CAT Score

  90 days

• FEV1

  90 days

• FEV1/FVC

  90 days

Study Arms (2)

Treatment Arm

ACTIVE COMPARATOR

OnabotulinumtoxinA

Drug: OnabotulinumtoxinA

Placebo Arm

PLACEBO COMPARATOR

Normal saline

Other: Placebo

Interventions

OnabotulinumtoxinA DRUG

BOTOX injection series

Also known as: BOTOX

Treatment Arm

Placebo OTHER

Placebo injection series

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• RMW Testing: lead

Study Sites (1)

Tranquil Clinical Research

Webster, Texas, 77598, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Victoria Do

  Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an Investigator-initiated a clinical trial to determine the safety and preliminary efficacy of subcutaneous injections of BOTOX in participants with moderate COPD. Participants will be treated with either one series of subcutaneous injections of BOTOX or of normal saline solution in the back in the T-1 to T-5 dermatome regions as indicated in Appendix A. Participants' COPD status will be measured using the COPD Assessment Test (CAT), Pulmonary Function Test (Spirometry), and 6 Minute Walk Test (6MWT).

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 21, 2023
• Study Start: October 1, 2023
• Primary Completion: April 24, 2024
• Study Completion: July 10, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)