Phase 3
Completed N=122
A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD
Source: ClinicalTrials.gov NCT03573817 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event — 7; 6; 3; 5 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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 Obstructive Pulmonary Disease (COPD) over 21 days.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event |
7; 6; 3; 5 | — |
| PRIMARY Number of Participants Who Experienced at Least One Serious Treatment-Emergent Adverse Event |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Relevant Changes in Vital Sign Measurements |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Relevant Changes in Clinical Laboratory Measurements |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Relevant Changes in Electrocardiogram Results |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03573817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.