A Phase 4 interventional study of Revefenacin and Tiotropium in Chronic Obstructive Pulmonary Disease, sponsored by Theravance Biopharma. Completed at 76 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by Theravance Biopharma · Phase 4, Interventional, and Treatment
Study is a randomized, double-blind, double-dummy, parallel-group study evaluating efficacy and safety of revefenacin vs. tiotropium in adults with severe to very severe COPD and suboptimal PIFR.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 404 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Theravance Biopharma is the lead sponsor of 47 studies on the registry; none are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 11 (46%) have results posted.
Counted across the registry records on this site, refreshed daily.
During the study and for 30 days after receiving the last dose of study drug, women of childbearing potential and men capable of fathering children must agree to use highly effective birth control measures or agree to abstain from sexual intercourse.
A highly effective method of birth control is defined as one that results in a low failure rate (i.e. \<1% per year) when used consistently and correctly, such as condom + diaphragm, condom + spermicide, diaphragm + spermicide, or intrauterine device [IUD] with documented failure rate of \<1% per year, or oral/injectable/implanted hormonal contraceptives used in combination with an additional barrier method.
Participant is willing and able to adhere to all restrictions during their study participation as follows:
Exclusion Criteria:
Revefenacin administered with Tiotropium Placebo
Drug: Revefenacin · Drug: Tiotropium Placebo
Tiotropium administered with Revefenacin Placebo
Drug: Tiotropium · Drug: Revefenacin Placebo
Revefenacin 175 mcg administered once daily for 84 days via nebulization
Also known as: Yupelri®, TD-4208
Tiotropium 18 mcg administered once daily for 84 days via Spiriva HandiHaler®
Also known as: Spiriva®
Placebo for Revefenacin administered once daily for 84 days via nebulization
Placebo for Tiotropium administered once daily for 84 days via Spiriva HandiHaler®
FEV1
Change from baseline in forced expiratory volume in one second (FEV1) at trough on Day 85
Time frame: Baseline, Day 85 following 84 days of dosing
OTE on FEV1
Trough Overall Treatment Effect (OTE) on FEV1. Overall is defined as the average change from baseline at trough across Day 30, Day 60, and Day 85.
Time frame: Baseline, Day 30, Day 60, Day 85
FEV1
Change from baseline in FEV1 at trough on Day 30
Time frame: Baseline, Day 30
FEV1
Change from baseline in FEV1 at trough on Day 60
Time frame: Baseline, Day 60
FVC
Change from baseline in forced vital capacity (FVC) at trough on Day 85
Time frame: Baseline, Day 85
80-mL Increase in FEV1 at Trough on Day 85
Participants with an 80-mL or greater change from baseline FEV1 at trough were counted as responders. Participants with change from baseline FEV1 \< 80 mL and participants with change from baseline FEV1 not obtained were counted as nonresponders.
Time frame: Baseline, Day 85
First Occurrence of CompEx Event
Count of participants experiencing events and time from first dose to first occurrence of a composite endpoint for exacerbations of COPD (CompEx) event were evaluated. The statistical analysis is a Cox proportional hazards model analysis of time to first event and the Revefenacin / Tiotropium hazard ratio is calculated and reported. Data are reported as the numbers of subjects with events and the hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table. CompEx events are a composite of moderate or severe COPD exacerbation, premature termination from the study for any reason other than Sponsor decision, and clinically relevant deterioration in COPD. Clinically relevant deterioration events are defined as increases in COPD symptoms meeting specified criteria based on participant diary data.
Time frame: Date of first dose through date of last dose + 7 days
| Milestone | Tiotropium | Revefenacin |
|---|---|---|
| Started | 191 | 190 |
| Completed | 156 | 147 |
| Not completed | 35 | 43 |
Change from baseline in forced expiratory volume in one second (FEV1) at trough on Day 85
| mL | Tiotropium | Revefenacin |
|---|---|---|
| FEV1 | 101 ± 17 | 78 ± 17 |
Trough Overall Treatment Effect (OTE) on FEV1. Overall is defined as the average change from baseline at trough across Day 30, Day 60, and Day 85.
| mL | Tiotropium | Revefenacin |
|---|---|---|
| OTE on FEV1 | 87 ± 15 | 78 ± 15 |
Change from baseline in FEV1 at trough on Day 30
| mL | Tiotropium | Revefenacin |
|---|---|---|
| FEV1 | 81 ± 16 | 83 ± 16 |
Change from baseline in FEV1 at trough on Day 60
| mL | Tiotropium | Revefenacin |
|---|---|---|
| FEV1 | 79 ± 17 | 73 ± 17 |
Change from baseline in forced vital capacity (FVC) at trough on Day 85
| mL | Tiotropium | Revefenacin |
|---|---|---|
| FVC | 198 ± 35 | 156 ± 35 |
Participants with an 80-mL or greater change from baseline FEV1 at trough were counted as responders. Participants with change from baseline FEV1 \< 80 mL and participants with change from baseline FEV1 not obtained were counted as nonresponders.
| Participants | Tiotropium | Revefenacin |
|---|---|---|
| 80-mL Increase in FEV1 at Trough on Day 85 | 83 | 63 |
Count of participants experiencing events and time from first dose to first occurrence of a composite endpoint for exacerbations of COPD (CompEx) event were evaluated. The statistical analysis is a Cox proportional hazards model analysis of time to first event and the Revefenacin / Tiotropium hazard ratio is calculated and reported. Data are reported as the numbers of subjects with events and the hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table. CompEx events are a composite of moderate or severe COPD exacerbation, premature termination from the study for any reason other than Sponsor decision, and clinically relevant deterioration in COPD. Clinically relevant deterioration events are defined as increases in COPD symptoms meeting specified criteria based on participant diary data.
| Participants | Tiotropium | Revefenacin |
|---|---|---|
| First Occurrence of CompEx Event | 56 | 58 |
Collected over Day 1 through 7 days after the date of the last study drug dose.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tiotropium | 0/191 (0%) | 15/191 (7.9%) | 33/191 (17.3%) |
| Revefenacin | 0/189 (0%) | 16/189 (8.5%) | 38/189 (20.1%) |
| Event | Tiotropium | Revefenacin |
|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 4/191 | 4/189 |
| Cardiac failure congestiveCardiac disorders | 0/191 | 3/189 |
| COVID-19Infections and infestations | 1/191 | 2/189 |
| PneumoniaInfections and infestations | 2/191 | 2/189 |
| Acute kidney injuryRenal and urinary disorders | 2/191 | 1/189 |
| Atrial fibrillationCardiac disorders | 0/191 | 1/189 |
| Cardiac arrestCardiac disorders | 0/191 | 1/189 |
| Chronic left ventricular failureCardiac disorders | 0/191 | 1/189 |
| ColitisGastrointestinal disorders | 0/191 | 1/189 |
| COVID-19 pneumoniaInfections and infestations | 0/191 | 1/189 |
| Event | Tiotropium | Revefenacin |
|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 22/191 | 22/189 |
| HeadacheNervous system disorders | 5/191 | 2/189 |
| Back painMusculoskeletal and connective tissue disorders | 2/191 | 4/189 |
| NauseaGastrointestinal disorders | 4/191 | 2/189 |
| COVID-19Infections and infestations | 1/191 | 3/189 |
| CellulitisInfections and infestations | 1/191 | 3/189 |
| NasopharyngitisInfections and infestations | 2/191 | 3/189 |
| Upper respiratory tract infectionInfections and infestations | 2/191 | 3/189 |
All participants who received study treatment
| Age, Continuous(years) | Tiotropium | Revefenacin | Total |
|---|---|---|---|
| Median | 66 (49 to 88) | 67 (47 to 83) | 66 (47 to 88) |
| Age, Customized(Participants) | Tiotropium | Revefenacin | Total |
|---|---|---|---|
| 40 to 64 years old | 81 | 79 | 160 |
| 65 years old and over | 110 | 110 | 220 |
| Sex: Female, Male(Participants) | Tiotropium | Revefenacin | Total |
|---|---|---|---|
| Female | 86 | 90 | 176 |
| Male | 105 | 99 | 204 |
| Ethnicity (NIH/OMB)(Participants) | Tiotropium | Revefenacin | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 7 | 9 |
| Not Hispanic or Latino | 176 | 172 | 348 |
| Unknown or Not Reported | 13 | 10 | 23 |
| Race (NIH/OMB)(Participants) | Tiotropium | Revefenacin | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 3 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 11 | 14 | 25 |
| White | 175 | 171 | 346 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Region of Enrollment(Participants) | Tiotropium | Revefenacin | Total |
|---|---|---|---|
| United States | 191 | 189 | 380 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
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