COPDPhase 2NCT06003049
A Study to Evaluate Safety and Efficacy of BOTOX in Adults With Moderate COPD
A Phase 2 study testing OnabotulinumtoxinA in people with COPD, run by RMW Testing at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- COPD
- What is being tested?
- OnabotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 10 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
Read the 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
- Being tested
- OnabotulinumtoxinA, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinADrug
Also called BOTOX
BOTOX injection series
PlaceboOther
Placebo injection series
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Active comparator | OnabotulinumtoxinA Receives: Drug: OnabotulinumtoxinA |
| Placebo Arm | Placebo comparator | Normal saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (6)
CAT (Change in Units)
The COPD Assessment Test (CAT) is assessed to capture the health status. The total score ranges from 0 to 40 points. Portion of participants with a change in score of 2 or greater are indicating a change health status between baseline and day 28 follow-up assessment.
Measured: 28 days
FEV1
Percentage of predicted (% pred) of the forced expiratory volume in 1 second (FEV1). FEV1 values that are ratios that are higher than at baseline suggest an improving health status. Assessment at Baseline and day 28 follow-up assessment
Measured: 28 days
FEV1/FVC
Ratio of percentage of predicted (% pred) of the forced expiratory volume in 1 second to (FEV1ercentage of predicted (% pred) of the forced vital capacity (FVC). FEV1/FVC ratios that are higher than at baseline suggest an improving health status. Assessment at baseline and day 28 follow-up assessment.
Measured: 28 days
6MWT
The six-minute walk test (6MWT) is performed to capture the longest 6MWT for further analyses. The longer distance covered indicates an improving health status. Assessment at baseline and day 28 follow-up assessment.
Measured: 28 days
COPD Exacerbations
Exacerbations of chronic obstructive pulmonary disease (COPD) are episodes of worsening of symptoms, leading to substantial morbidity and mortality. Total number of exacerbations will be analyzed and measured at baseline, all follow-up and end of trial assessments. More exacerbations experienced over time indicate a worse health status.
Measured: 90 days
Adverse Reactions
The number of reported adverse reactions and serious adverse events per participant. The more adverse reactions, the worse the health status of the participant measured at baseline, all follow-up and end of trial assessments.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Oct 2023
- Primary completion24 Apr 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- RMW Testing
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victoria Do, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003049
- Sponsor's protocol ID
- COPD 101
- Status last verified
- Jan 2024
- First submitted
- 4 Aug 2023
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06003049
- Acronym / sponsor ID
- COPD 101
- Conditions
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- RMW TestingIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Active comparator | Drug: OnabotulinumtoxinAOnabotulinumtoxinA |
| Placebo Arm | Placebo comparator | Other: PlaceboNormal saline |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnabotulinumtoxinAAlso: BOTOXBOTOX injection series | Drug | Treatment Arm |
| PlaceboPlacebo injection series | Other | Placebo Arm |
Primary outcome
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.
6 secondary outcomes
CAT (Change in Units)
Time frame: 28 days
FEV1
Time frame: 28 days
FEV1/FVC
Time frame: 28 days
6MWT
Time frame: 28 days
COPD Exacerbations
Time frame: 90 days
Adverse Reactions
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Do principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OnabotulinumtoxinA in people with COPD, run by RMW Testing at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAT (Average) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.