COPDPhase 2NCT02040792

A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 study testing TD-4208 in people with COPD, 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.

Trial summary

This study evaluated the safety and efficacy of four doses of TD-4208 and a placebo product when administered once daily for 28 days using a jet nebulizer to patients with moderate to severe chronic obstructive pulmonary disease. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: COPD
What is being tested?: TD-4208
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 355 participants
Where: 1 siteUnited States
Study dates: May 2014to Aug 2014
Phase: Phase 2
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
Subject must have a negative pregnancy test, and must be prepared to use effective contraception if of child-bearing potential
Subject is capable of performing reproducible spirometry maneuvers
Subject has post-bronchodilator FEV1/FVC ratio <0.7
Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the GOLD Guidelines)
Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal
Subject has a current or past smoking history of at least 10 pack-years.

Who cannot join

Subject has a significant respiratory disease or disorder other than COPD that would affect the interpretation of data from this study
Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergic or beta-agonist agents
Subject suffers from any medical condition that would preclude the use of inhaled anticholinergic agents
Subject has been hospitalized for COPD or pneumonia within 12 weeks
Subject requires long-term oxygen therapy (>15 hours a day)

Trial locations and contacts

1 site in 1 country.

United States1 site

Upstate Pharmaceutical Research
Greenville, South Carolina, 29615

Other trials in United States

About this study

Official title: A Phase 2B, 28-Day, Randomized, Double-Blind Placebo-Controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

Conditions: COPD
Being tested: TD-4208, Placebo
Keywords: COPD, Chronic Obstructive Pulmonary Disease
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.

TD-4208Drug
Also called revefenacin
PlaceboDrug

Study groups in NCT02040792
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo
44 mcg	Experimental	TD-4208 Receives: Drug: TD-4208
88 mcg	Experimental	TD-4208 Receives: Drug: TD-4208
175 mcg	Experimental	TD-4208 Receives: Drug: TD-4208
350 mcg	Experimental	TD-4208 Receives: Drug: TD-4208

What is being measured

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

Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second)
Measured: Baseline to 28 days

Timeline

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

May 2014Aug 2014

First posted20 Jan 2014 (estimated)
Study startMay 2014
Primary completionJul 2014
Study completionAug 2014

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 (2)Papers the sponsor has linked to this study.
Other trials for 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 355 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02040792
Sponsor's protocol ID: 0117
Status last verified: Feb 2022
First submitted: 16 Jan 2014
Last updated: 24 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lo A, Borin MT, Bourdet DL. Population Pharmacokinetics of Revefenacin in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2021 Mar;60(3):391-401. doi: 10.1007/s40262-020-00938-3.
PubMed 33124005
Pudi KK, Barnes CN, Moran EJ, Haumann B, Kerwin E. A 28-day, randomized, double-blind, placebo-controlled, parallel group study of nebulized revefenacin in patients with chronic obstructive pulmonary disease. Respir Res. 2017 Nov 2;18(1):182. doi: 10.1186/s12931-017-0647-1.
PubMed 29096627

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

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

All 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 2B, 28-Day, Randomized, Double-Blind Placebo-Controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT02040792
Acronym / sponsor ID: 0117
Conditions: COPD
Keywords: COPD, Chronic Obstructive Pulmonary Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 355 participants (actual)
Lead sponsor: Mylan Inc.Industry (pharma, biotech, devices)
Collaborators: Theravance Biopharma
Study start: May 2014
Primary completion: Jul 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 20 Jan 2014 (estimated)
Results: Posted 7 Dec 2016

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: 5

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo
44 mcg	Experimental	Drug: TD-4208TD-4208
88 mcg	Experimental	Drug: TD-4208TD-4208
175 mcg	Experimental	Drug: TD-4208TD-4208
350 mcg	Experimental	Drug: TD-4208TD-4208

Who may qualify

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

Key inclusion criteria (7 listed)

Subject is a male or female subject 40 years of age or older
Subject must have a negative pregnancy test, and must be prepared to use effective contraception if of child-bearing potential
Subject is capable of performing reproducible spirometry maneuvers
Subject has post-bronchodilator FEV1/FVC ratio <0.7
Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the GOLD Guidelines)

Key exclusion criteria (5 listed)

Subject has a significant respiratory disease or disorder other than COPD that would affect the interpretation of data from this study
Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergic or beta-agonist agents
Subject suffers from any medical condition that would preclude the use of inhaled anticholinergic agents
Subject has been hospitalized for COPD or pneumonia within 12 weeks
Subject requires long-term oxygen therapy (>15 hours a day)

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
TD-4208Also: revefenacin	Drug	175 mcg, 350 mcg, 44 mcg, 88 mcg
Placebo	Drug	Placebo

Primary outcome

Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second)
Time frame: Baseline to 28 days

Results and safety

Results posted to the registry on 7 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	70	64
44 mcg	68	65
88 mcg	71	68
175 mcg	71	64
350 mcg	74	67

Primary outcome: Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second)

Time frame: Baseline to 28 days. Least squares mean (Standard Error). Unit: mL

Measure	Placebo n = 70	44 mcg n = 68	88 mcg n = 71	175 mcg n = 71	350 mcg n = 74
Value	-32.4 (25.36)	19.4 (24.98)	155.0 (24.61)	134.2 (25.07)	138.2 (24.38)

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 71 (0%)	8 of 71 (11.3%)	Not reported
44 mcg	1 of 68 (1.5%)	1 of 68 (1.5%)	Not reported
88 mcg	0 of 71 (0%)	6 of 71 (8.5%)	Not reported
175 mcg	2 of 71 (2.8%)	10 of 71 (14.1%)	Not reported
350 mcg	1 of 74 (1.4%)	15 of 74 (20.3%)	Not reported

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 33124005Lo A, Borin MT, Bourdet DL. Population Pharmacokinetics of Revefenacin in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2021 Mar;60(3):391-401. doi: 10.1007/s40262-020-00938-3.
Derived from this study: PubMed 29096627Pudi KK, Barnes CN, Moran EJ, Haumann B, Kerwin E. A 28-day, randomized, double-blind, placebo-controlled, parallel group study of nebulized revefenacin in patients with chronic obstructive pulmonary disease. Respir Res. 2017 Nov 2;18(1):182. doi: 10.1186/s12931-017-0647-1.

Related trials for COPD

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

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.

Medial 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?

A Phase 2 study testing TD-4208 in people with COPD, run by Mylan Inc. at 1 site 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 7 inclusion and 5 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 7 Dec 2016). 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 (Forced Expiratory Volume in One Second) (time frame: Baseline to 28 days). 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 NCT02040792, which also lists 2 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.