Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT03573817
A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD
A Phase 3 study testing Revefenacin and Formoterol in people with Chronic Obstructive Pulmonary Disease (COPD), run by Mylan Inc. at 12 sites in United States.
Trial summary
The primary objective of the study was to characterize the safety and tolerability of once-daily revefenacin inhalation solution when dosed sequentially with twice-daily formoterol inhalation solution (PERFOROMIST®) compared to PERFOROMIST®, in a population of participants with moderate-to-very severe Chronic… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Revefenacin and Formoterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 12 sitesUnited States
- Study dates
- 31 May 2018to 25 Sep 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is a male or female subject 40 years of age or older.
- Participant is willing and able to provide signed and dated written informed consent.
- Participant has a current or past cigarette smoking history (or equivalent for cigar or pipe smoking history) of at least 10 pack-years.
- Participant must be willing and able to attend study visits according to the visit schedule and adhere to all study assessments/procedures.
Who cannot join
- Participant has a concurrent disease or condition that, in the opinion of the investigator, would interfere with study participation or confound the evaluation of safety, tolerability, or pharmacokinetics of the study drug.
- Participant has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergics, short-acting beta-agonists and long-acting beta-agonists.
- Participant with clinically significant and uncontrolled hypertension, hypercholesterolemia or Type II diabetes mellitus, as assessed by the investigator.
- Participant is unwilling or unable to stop the use of prohibited medications during the washout (if required) and treatment period and follow-up period of the study.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Theravance Biopharma Investigational Site
Columbus, Ohio, 43213
Theravance Biopharma Investigational Site
Erie, Pennsylvania, 16508
Theravance Biopharma Investigational Site
Gaffney, South Carolina, 29341
Theravance Biopharma Investigational Site
Greenville, South Carolina, 29615
Theravance Biopharma Investigational Site
Medford, Oregon, 97504
Theravance Biopharma Investigational Site
Miami, Florida, 33155
Theravance Biopharma Investigational Site
Monroe, North Carolina, 28112
Theravance Biopharma Investigational Site
Orlando, Florida, 32825
Theravance Biopharma Investigational Site
Saint Charles, Missouri, 63301
Theravance Biopharma Investigational Site
Sarasota, Florida, 34239
Theravance Biopharma Investigational Site
Spartanburg, South Carolina, 29303
Theravance Biopharma Investigational Site
Tampa, Florida, 33603
About this study
Official title: A Phase 3b, 42-day, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Tolerability of Nebulized Revefenacin and Nebulized Formoterol Fumarate (PERFOROMIST®) Administered in Sequence and as a Combined Solution in Subjects With Chronic Obstructive Pulmonary Disease
The primary objective of the study was to characterize the safety and tolerability of once-daily revefenacin inhalation solution when dosed sequentially with twice-daily formoterol inhalation solution (PERFOROMIST®) compared to PERFOROMIST®, in a population of participants with moderate-to-very severe Chronic Obstructive Pulmonary Disease (COPD) over 21 days.
- Being tested
- Revefenacin, Placebo, Formoterol
- Keywords
- Chronic Obstructive Pulmonary Disease, Pulmonary Function, COPD, Performist
- 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.
RevefenacinDrug
Also called TD-4208
Revefenacin is administered via a nebulizer.
PlaceboDrug
Placebo version of Revefenacin is administered via a nebulizer.
FormoterolDrug
Administered sequentially in both revefenacin and placebo arms using a nebulizer.
| Study group | Role | What they receive |
|---|---|---|
| Period 1: Revefenacin + Formoterol (Sequential) | Experimental | Days 1 to 21: Revefenacin and formoterol will be sequentially administered in the morning. Formoterol will be administered again in the evening. Receives: Drug: Revefenacin; Drug: Formoterol |
| Period 2: Revefenacin + Formoterol (Combo Solution) | Experimental | Days 22 to 42: After a 21 day period, the participants from the Revefenacin + Formoterol (Sequential) Arm will be dosed for 21 days with a combination of revefenacin and formoterol administered as a combined solution. Formoterol will be administered again in the evening. Receives: Drug: Revefenacin; Drug: Formoterol |
| Period 1: Placebo + Formoterol (Sequential) | Placebo comparator | Days 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered in the morning. Formoterol will be administered again in the evening. Receives: Drug: Placebo; Drug: Formoterol |
| Period 2: Placebo + Formoterol (Combo Solution) | Placebo comparator | Days 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution. Formoterol will be administered again in the evening. Receives: Drug: Placebo; Drug: Formoterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurred after the participant has received the study drug.
Measured: Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
Number of Participants Who Experienced at Least One Serious Treatment-Emergent Adverse Event
A serious adverse event (SAE) was defined as any untoward medical occurrence occurring at any dose that resulted in any of the following outcomes:
- Death
- Life-threatening situation. "Life-threatening" refers to a situation in which the participant was at risk of death at the time of the event; it does not refer to an event which might have caused death if it were more severe
- Inpatient hospitalization or prolongation of existing hospitalization
- Congenital anomaly in the offspring of a participant who received study drug
- Important medical events that may not result in death, be immediately life-threatening, or require hospitalization, could have been considered an SAE when, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition
A treatment-emergent SAE is an SAE that occurred after the participant has received the study drug.
Measured: Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
Number of Participants With Clinically Relevant Changes in Vital Sign Measurements
Clinically significant changes identified based on change from baseline. Vital signs measured included heart rate, systolic blood pressure and diastolic blood pressure.
Measured: Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
Number of Participants With Clinically Relevant Changes in Clinical Laboratory Measurements
Clinically relevant changes identified based on change from baseline. Laboratory Measures assessed included hematology and serum.
Measured: Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
Number of Participants With Clinically Relevant Changes in Electrocardiogram Results
Clinically relevant changes identified based on change from baseline.
Measured: Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start31 May 2018
- Primary completion25 Sep 2018
- Study completion25 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind, placebo-controlled, parallel-group study. Each participant will receive treatment daily for a total of 42 days. One group will receive placebo and formoterol and one group will receive revefenacin and formoterol.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Theravance Biopharma
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Theravance Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573817
- Sponsor's protocol ID
- 0167
- Status last verified
- Feb 2022
- First submitted
- 24 May 2018
- Last updated
- 24 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, 42-day, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Tolerability of Nebulized Revefenacin and Nebulized Formoterol Fumarate (PERFOROMIST®) Administered in Sequence and as a Combined Solution in Subjects With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03573817
- Acronym / sponsor ID
- 0167
- Keywords
- Chronic Obstructive Pulmonary Disease, Pulmonary Function, COPD, Performist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Mylan Inc.Industry (pharma, biotech, devices)
- Collaborators
- Theravance Biopharma
- Study start
- 31 May 2018 (actual)
- Primary completion
- 25 Sep 2018 (actual)
- Study completion
- 25 Sep 2018 (actual)
- First posted
- 29 Jun 2018 (actual)
- Results
- Posted 18 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study was to characterize the safety and tolerability of once-daily revefenacin inhalation solution when dosed sequentially with twice-daily formoterol inhalation solution (PERFOROMIST®) compared to PERFOROMIST®, in a population of participants with moderate-to-very severe Chronic Obstructive Pulmonary Disease (COPD) over 21 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a randomized, double-blind, placebo-controlled, parallel-group study. Each participant will receive treatment daily for a total of 42 days. One group will receive placebo and formoterol and one group will receive revefenacin and formoterol.
| Arm | Type | Receives |
|---|---|---|
| Period 1: Revefenacin + Formoterol (Sequential) | Experimental | Drug: Revefenacin, Drug: FormoterolDays 1 to 21: Revefenacin and formoterol will be sequentially administered in the morning. Formoterol will be administered again in the evening. |
| Period 2: Revefenacin + Formoterol (Combo Solution) | Experimental | Drug: Revefenacin, Drug: FormoterolDays 22 to 42: After a 21 day period, the participants from the Revefenacin + Formoterol (Sequential) Arm will be dosed for 21 days with a combination of revefenacin and formoterol administered as a combined solution. Formoterol will be administered again in the evening. |
| Period 1: Placebo + Formoterol (Sequential) | Placebo comparator | Drug: Placebo, Drug: FormoterolDays 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered in the morning. Formoterol will be administered again in the evening. |
| Period 2: Placebo + Formoterol (Combo Solution) | Placebo comparator | Drug: Placebo, Drug: FormoterolDays 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution. Formoterol will be administered again in the evening. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant is a male or female subject 40 years of age or older.
- Participant is willing and able to provide signed and dated written informed consent.
- Participant has a current or past cigarette smoking history (or equivalent for cigar or pipe smoking history) of at least 10 pack-years.
- Participant must be willing and able to attend study visits according to the visit schedule and adhere to all study assessments/procedures.
Key exclusion criteria (4 listed)
- Participant has a concurrent disease or condition that, in the opinion of the investigator, would interfere with study participation or confound the evaluation of safety, tolerability, or pharmacokinetics of the study drug.
- Participant has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergics, short-acting beta-agonists and long-acting beta-agonists.
- Participant with clinically significant and uncontrolled hypertension, hypercholesterolemia or Type II diabetes mellitus, as assessed by the investigator.
- Participant is unwilling or unable to stop the use of prohibited medications during the washout (if required) and treatment period and follow-up period of the study.
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 |
|---|---|---|
| RevefenacinAlso: TD-4208Revefenacin is administered via a nebulizer. | Drug | Period 1: Revefenacin + Formoterol (Sequential), Period 2: Revefenacin + Formoterol (Combo Solution) |
| PlaceboPlacebo version of Revefenacin is administered via a nebulizer. | Drug | Period 1: Placebo + Formoterol (Sequential), Period 2: Placebo + Formoterol (Combo Solution) |
| FormoterolAdministered sequentially in both revefenacin and placebo arms using a nebulizer. | Drug | Period 1: Placebo + Formoterol (Sequential), Period 1: Revefenacin + Formoterol (Sequential), Period 2: Placebo + Formoterol (Combo Solution), Period 2: Revefenacin + Formoterol (Combo Solution) |
Primary outcome
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event
Time frame: Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurred after the participant has received the study drug.
Number of Participants Who Experienced at Least One Serious Treatment-Emergent Adverse Event
Time frame: Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
A serious adverse event (SAE) was defined as any untoward medical occurrence occurring at any dose that resulted in any of the following outcomes: * Death * Life-threatening situation. "Life-threatening" refers to a situation in which the participant was at risk of death at the time of the event; it does not refer to an event which might have caused death if it were more severe * Inpatient hospitalization or prolongation of existing hospitalization * Congenital anomaly in the offspring of a participant who received study drug * Important medical events that may not result in death, be immediately life-threatening, or require hospitalization, could have been considered an SAE when, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition A treatment-emergent SAE is an SAE that occurred after the participant has received the study drug.
Number of Participants With Clinically Relevant Changes in Vital Sign Measurements
Time frame: Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
Clinically significant changes identified based on change from baseline. Vital signs measured included heart rate, systolic blood pressure and diastolic blood pressure.
Number of Participants With Clinically Relevant Changes in Clinical Laboratory Measurements
Time frame: Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
Clinically relevant changes identified based on change from baseline. Laboratory Measures assessed included hematology and serum.
Number of Participants With Clinically Relevant Changes in Electrocardiogram Results
Time frame: Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
Clinically relevant changes identified based on change from baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
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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.
Medical Monitor study director
Theravance Biopharma
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Revefenacin and Formoterol in people with Chronic Obstructive Pulmonary Disease (COPD), run by Mylan Inc. at 12 sites 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 4 inclusion and 4 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 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (time frame: Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)). The study lists 5 primary outcomes in all. 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 24 Feb 2022.