7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

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

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-12-31

Brief Summary

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This study will characterize the dose response of TD-4208 after 7 days of dosing in subjects with Chronic Obstructive Pulmonary Disease (COPD).

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Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dose 1 TD-4208

22 µg

Group Type EXPERIMENTAL

TD-4208

Intervention Type DRUG

Dose 2 TD-4208

44 µg

Group Type EXPERIMENTAL

TD-4208

Intervention Type DRUG

Dose 3 TD-4208

88 µg

Group Type EXPERIMENTAL

TD-4208

Intervention Type DRUG

Dose 4 TD-4208

175 µg

Group Type EXPERIMENTAL

TD-4208

Intervention Type DRUG

Dose 5 TD-4208

350 µg

Group Type EXPERIMENTAL

TD-4208

Intervention Type DRUG

Dose 6 TD-4208

700 µg

Group Type EXPERIMENTAL

TD-4208

Intervention Type DRUG

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

1. Subject is a male or female between the ages of 40 and 75 years (inclusive, at randomization).
2. Subject:

* Has an FEV1/FVC (forced expiratory volume in 1 second/forced vital capacity) \<0.7 at screening; and
* Has a post-bronchodilator FEV1 at screening of between 30% and 80% (inclusive) of the predicted normal value.
3. Subject demonstrates at screening at least a 120 mL increase in FEV1 within 1 hour of receiving 500 µg of ipratropium bromide from a PARI LC Sprint® nebulizer.
4. Females of non-childbearing potential. All male subjects must agree to use a highly effective method of birth control with partners of childbearing potential during the study and for 1 month after completion of study dosing.
5. Subject (or care giver) is able to properly prepare and administer study medication.
6. Subject is willing and able to give written informed consent to participate.

Exclusion Criteria

1. Subject has had a COPD exacerbation or lung infection within 6 weeks before randomization.
2. Subject has had an initiation of treatment, or a change in dose, of an inhaled or oral corticosteroid, or long-acting beta2 agonist (LABA), or long-acting muscarinic antagonist (LAMA) within 4 weeks before the qualifying ipratropium bromide response test.
3. Subject is taking daily maintenance inhaled/systemic corticosteroids (\>1000 μg of fluticasone propionate equivalent or ≥10 mg prednisone).
4. Subject has an uncontrolled hematologic, immunologic, renal, neurologic, hepatic, endocrine, or other disease or condition based on information gathered from the medical history, physical examination, or laboratory findings that might place the subject at undue risk or potentially compromise the results or interpretation of the study.
5. Subject has a history of significant cerebrovascular disease, coronary artery disease, or cardiac arrhythmias. Subject has a history (or family history) of congenital prolonged QTc (corrected QT interval) syndrome or has an abnormal clinically significant electrocardiogram (ECG) at screening, including QTcB (QT interval corrected for heart rate using Bazett's formula) value \>450 msec (males) or \>470 msec (females); or shows evidence of clinically significant rhythm abnormality.
6. Subject has a known hypersensitivity to TD-4208 or similar drug class.
7. Subject has a history of alcoholism or drug abuse within 2 years prior to screening.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No