Phase 3
Completed N=207
Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD
Chronic Obstructive Pulmonary Disease · Low Peak Inspiratory Flow Rate (PIFR)
Source: ClinicalTrials.gov NCT03095456 ↗
Enrolled (actual)
207
Serious AEs
0.5%
Results posted
Dec 2018
Primary outcomePrimary: Change From Baseline in Trough FEV1 on Day 29 — 63.0; 47.3 mL
◆ Published Evidence
Established
33citations · ~5 / year
Nebulized Versus Dry Powder Long-Acting Muscarinic Antagonist Bronchodilators in Patients With COPD and Suboptimal Peak Inspiratory Flow Rate.
Summary
This study is a randomized, double-blind, double-dummy, parallel group study to compare once daily nebulized Revefenacin with Spiriva once daily delivered via the HandiHaler® on lung function in subjects with COPD and a Low Peak Inspiratory Flow Rate.
Linked Publications (3)
-
Nebulized Versus Dry Powder Long-Acting Muscarinic Antagonist Bronchodilators in Patients With COPD and Suboptimal Peak Inspiratory Flow Rate.
-
Peak Inspiratory Flows: Defining Repeatability Limits and a Predictive Equation for Different Inhalers.
-
Clinical Burden of Chronic Obstructive Pulmonary Disease in Patients with Suboptimal Peak Inspiratory Flow.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough FEV1 on Day 29 |
63.0; 47.3 | — |
| SECONDARY Change From Baseline Trough FVC (Forced Vital Capacity) on Day 29 |
125.4; 55.8 | — |
| SECONDARY Change From Baseline Trough Inspiratory Capacity (IC) on Day 29 |
71.4; 84.1 | — |
| SECONDARY Change From Baseline Peak FEV1 on Day 29 |
174.2; 197.7 | — |
| SECONDARY Change From Baseline Peak FVC on Day 29 |
354.2; 340.1 | — |
| SECONDARY Summary of Rescue Medication Use: Puffs Per Day |
3.4; 2.9 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is a male or female subject 40 years of age or older with a diagnosis of COPD.
- Subject has a current or past cigarette smoking history (or equivalent for cigar or pipe smoking history) of at least 10 pack-years.
- Subject is willing and able to provide signed and dated written informed consent to participate prior to initiation of any study related procedures.
Exclusion Criteria
- Subject has a concurrent disease or condition that, in the opinion of the investigator, would interfere with continued study participation or confound the evaluation of safety and tolerability of the study drug.
- Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergics.
- Subject suffers from any medical condition that would preclude the use of inhaled anticholinergics, including narrow-angle glaucoma, symptomatic benign prostatic hyperplasia, bladder neck obstruction, or urinary retention.
Data sourced from ClinicalTrials.gov (NCT03095456) and the linked publication. 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.