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Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT02459080

Last Updated: 2022-02-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

619 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-09-30

Brief Summary

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The purpose of this study is to measure the effectiveness and safety of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to placebo, a treatment without activity.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TD-4208-1

88 mcg

Group Type ACTIVE_COMPARATOR

TD-4208

Intervention Type DRUG

TD-4208-2

175 mcg

Group Type ACTIVE_COMPARATOR

TD-4208

Intervention Type DRUG

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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TD-4208

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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revefenacin

Eligibility Criteria

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Inclusion Criteria

* Subject is a male or female subject 40 years of age or older

Exclusion Criteria

* Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Theravance Biopharma

INDUSTRY

Sponsor Role collaborator

Mylan Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Theravance Biopharma

Locations

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Allergy Associates Research Center (AARC)

Portland, Oregon, United States

Site Status

Countries

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United States

References

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Donohue JF, Ferguson GT, Ohar JA, Lombardi DA, Schneider RF, Johnson K. Improvements in health status with revefenacin, a once-daily, nebulized, long-acting muscarinic antagonist for chronic obstructive pulmonary disease. Respir Med. 2023 Mar;208:107123. doi: 10.1016/j.rmed.2023.107123. Epub 2023 Jan 18.

Reference Type DERIVED
PMID: 36681255 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33124005 (View on PubMed)

Donohue JF, Kerwin E, Barnes CN, Moran EJ, Haumann B, Crater GD. Efficacy of revefenacin, a long-acting muscarinic antagonist for nebulized therapy, in patients with markers of more severe COPD: a post hoc subgroup analysis. BMC Pulm Med. 2020 May 11;20(1):134. doi: 10.1186/s12890-020-1156-4.

Reference Type DERIVED
PMID: 32393215 (View on PubMed)

Other Identifiers

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0126

Identifier Type: -

Identifier Source: org_study_id

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