Chronic Obstructive Pulmonary Disease, COPDPhase 3NCT03095456

Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD

A Phase 3 study testing Revefenacin and Spiriva Handihaler® in people with Chronic Obstructive Pulmonary Disease, COPD and Low Peak Inspiratory Flow Rate (PIFR), run by Mylan Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease, COPD, Low Peak Inspiratory Flow Rate (PIFR)
What is being tested?: Revefenacin and Spiriva Handihaler®
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 207 participants
Where: 1 siteUnited States
Study dates: 27 Mar 2017to 25 Nov 2017
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

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732

Other trials in United States

About this study

Official title: A Phase 3b, 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 PIFR

Conditions: Chronic Obstructive Pulmonary Disease, COPD, Low Peak Inspiratory Flow Rate (PIFR)
Being tested: Revefenacin, Spiriva Handihaler®, Placebo for Revefenacin, Placebo for Spiriva Handihaler®
Keywords: Chronic Obstructive Pulmonary Disease, COPD, Low Peak Inspiratory Flow Rate (PIFR)
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 administered via nebulization.
Spiriva Handihaler®Combination product
Also called Tiotropium
Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.
Placebo for RevefenacinDrug
Placebo administered as double blind, double dummy via nebulization.
Placebo for Spiriva Handihaler®Drug
Placebo administered as double blind, double dummy via Spiriva HandiHaler®.

Study groups in NCT03095456
Study group	Role	What they receive
Revefenacin	Experimental	Active Revefenacin and placebo (in place of Spiriva Handihaler®) Receives: Drug: Revefenacin; Drug: Placebo for Spiriva Handihaler®
Spiriva Handihaler®	Active comparator	Active Spiriva Handihaler® and placebo (in place of Revefenacin) Receives: Combination Product: Spiriva Handihaler®; Drug: Placebo for Revefenacin

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Trough FEV1 on Day 29
FEV1 = forced expiratory volume at one second
Measured: Baseline and Day 29

Secondary outcomes (5)

Change From Baseline Trough FVC (Forced Vital Capacity) on Day 29
Measured: Baseline and Day 29
Change From Baseline Trough Inspiratory Capacity (IC) on Day 29
Measured: Baseline and Day 29
Change From Baseline Peak FEV1 on Day 29
Measured: Baseline and Day 29 (0-4 hours)
Change From Baseline Peak FVC on Day 29
Measured: Baseline and Day 29 (0-4 hours)
Summary of Rescue Medication Use: Puffs Per Day
Measured: 1 Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 201725 Nov 2017

First posted29 Mar 2017
Study start27 Mar 2017
Primary completion25 Nov 2017
Study completion25 Nov 2017

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.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary Disease, 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03095456
Sponsor's protocol ID: 0149
Status last verified: Feb 2022
First submitted: 24 Mar 2017
Last updated: 24 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Ohar JA, Mahler DA, Davis GN, Lombardi DA, Moran EJ, Crater GD. Clinical Burden of Chronic Obstructive Pulmonary Disease in Patients with Suboptimal Peak Inspiratory Flow. Can Respir J. 2024 Mar 22;2024:8034923. doi: 10.1155/2024/8034923. eCollection 2024.
PubMed 38560416
Barnes CN, Mahler DA, Ohar JA, Lombardi DA, Crater GD. Peak Inspiratory Flows: Defining Repeatability Limits and a Predictive Equation for Different Inhalers. Chest. 2020 Oct;158(4):1413-1419. doi: 10.1016/j.chest.2020.03.072. Epub 2020 Apr 25.
PubMed 32343967
Mahler DA, Ohar JA, Barnes CN, Moran EJ, Pendyala S, Crater GD. Nebulized Versus Dry Powder Long-Acting Muscarinic Antagonist Bronchodilators in Patients With COPD and Suboptimal Peak Inspiratory Flow Rate. Chronic Obstr Pulm Dis. 2019 Oct 23;6(4):321-31. doi: 10.15326/jcopdf.6.4.2019.0137.
PubMed 31647854

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Obstructive Pulmonary Disease, COPD trials

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, 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 PIFR
ClinicalTrials.gov ID: NCT03095456
Acronym / sponsor ID: 0149
Conditions: Chronic Obstructive Pulmonary Disease, COPD, Low Peak Inspiratory Flow Rate (PIFR)
Keywords: Chronic Obstructive Pulmonary Disease, COPD, Low Peak Inspiratory Flow Rate (PIFR)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 207 participants (actual)
Lead sponsor: Mylan Inc.Industry (pharma, biotech, devices)
Collaborators: Theravance Biopharma
Study start: 27 Mar 2017 (actual)
Primary completion: 25 Nov 2017 (actual)
Study completion: 25 Nov 2017 (actual)
First posted: 29 Mar 2017 (actual)
Results: Posted 31 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Revefenacin	Experimental	Drug: Revefenacin, Drug: Placebo for Spiriva Handihaler®Active Revefenacin and placebo (in place of Spiriva Handihaler®)
Spiriva Handihaler®	Active comparator	Combination Product: Spiriva Handihaler®, Drug: Placebo for RevefenacinActive Spiriva Handihaler® and placebo (in place of Revefenacin)

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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.

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 administered via nebulization.	Drug	Revefenacin
Spiriva Handihaler®Also: TiotropiumSpiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.	Combination product	Spiriva Handihaler®
Placebo for RevefenacinPlacebo administered as double blind, double dummy via nebulization.	Drug	Spiriva Handihaler®
Placebo for Spiriva Handihaler®Placebo administered as double blind, double dummy via Spiriva HandiHaler®.	Drug	Revefenacin

Primary outcome

Change From Baseline in Trough FEV1 on Day 29
Time frame: Baseline and Day 29
FEV1 = forced expiratory volume at one second

5 secondary outcomes

Change From Baseline Trough FVC (Forced Vital Capacity) on Day 29
Time frame: Baseline and Day 29
Change From Baseline Trough Inspiratory Capacity (IC) on Day 29
Time frame: Baseline and Day 29
Change From Baseline Peak FEV1 on Day 29
Time frame: Baseline and Day 29 (0-4 hours)
Change From Baseline Peak FVC on Day 29
Time frame: Baseline and Day 29 (0-4 hours)
Summary of Rescue Medication Use: Puffs Per Day
Time frame: 1 Month

Results and safety

Results posted to the registry on 31 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Revefenacin	103	99
Spiriva Handihaler®	104	96

Primary outcome: Change From Baseline in Trough FEV1 on Day 29

Time frame: Baseline and Day 29. Least squares mean (Standard Error). Unit: mL

Measure	Revefenacin n = 89	Spiriva Handihaler® n = 90
Value	63.0 (20.17)	47.3 (19.06)

Population analysed: Intent-to-treat (ITT) analysis set

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing of ICF through the final follow-up assessment (approximately 1 month).. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Revefenacin	0 of 103 (0%)	5 of 103 (4.9%)	0 of 103
Spiriva Handihaler®	1 of 104 (1%)	21 of 104 (20.2%)	0 of 104

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.
Derived from this study: PubMed 38560416Ohar JA, Mahler DA, Davis GN, Lombardi DA, Moran EJ, Crater GD. Clinical Burden of Chronic Obstructive Pulmonary Disease in Patients with Suboptimal Peak Inspiratory Flow. Can Respir J. 2024 Mar 22;2024:8034923. doi: 10.1155/2024/8034923. eCollection 2024.
Derived from this study: PubMed 32343967Barnes CN, Mahler DA, Ohar JA, Lombardi DA, Crater GD. Peak Inspiratory Flows: Defining Repeatability Limits and a Predictive Equation for Different Inhalers. Chest. 2020 Oct;158(4):1413-1419. doi: 10.1016/j.chest.2020.03.072. Epub 2020 Apr 25.
Derived from this study: PubMed 31647854Mahler DA, Ohar JA, Barnes CN, Moran EJ, Pendyala S, Crater GD. Nebulized Versus Dry Powder Long-Acting Muscarinic Antagonist Bronchodilators in Patients With COPD and Suboptimal Peak Inspiratory Flow Rate. Chronic Obstr Pulm Dis. 2019 Oct 23;6(4):321-31. doi: 10.15326/jcopdf.6.4.2019.0137.

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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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 3 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 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. 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 31 Dec 2018). 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?

Change From Baseline in Trough FEV1 on Day 29 (time frame: Baseline and Day 29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03095456, which also lists 3 linked publications.

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.