7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
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ClinicalTrials.gov Identifier: NCT01704404 |
Recruitment Status :
Completed
First Posted : October 11, 2012
Results First Posted : March 13, 2017
Last Update Posted : February 24, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COPD | Drug: TD-4208 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 62 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Study of the Pharmacodynamics, Safety and Tolerability, and Pharmacokinetics of Multiple Doses of TD-4208 for 7 Days in Subjects Diagnosed With Chronic Obstructive Pulmonary Disease |
Study Start Date : | December 2012 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Dose 1 TD-4208
22 µg
|
Drug: TD-4208
Other Name: revefenacin |
Experimental: Dose 2 TD-4208
44 µg
|
Drug: TD-4208
Other Name: revefenacin |
Experimental: Dose 3 TD-4208
88 µg
|
Drug: TD-4208
Other Name: revefenacin |
Experimental: Dose 4 TD-4208
175 µg
|
Drug: TD-4208
Other Name: revefenacin |
Experimental: Dose 5 TD-4208
350 µg
|
Drug: TD-4208
Other Name: revefenacin |
Experimental: Dose 6 TD-4208
700 µg
|
Drug: TD-4208
Other Name: revefenacin |
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo |
- Change From Baseline to Day 7 in Trough FEV1 (Forced Expiratory Volume in 1 Second) [ Time Frame: From baseline to day 7 ]
- Cmax [ Time Frame: From baseline to day 7 ]
Day 1: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, and 6 hours.
Day 7: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours.
- Tmax [ Time Frame: From baseline to day 7 ]
Day 1: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, and 6 hours.
Day 7: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours.
- Plasma Half-life [ Time Frame: From baseline to day 7 ]
Day 1: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, and 6 hours.
Day 7: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours.

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Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject is a male or female between the ages of 40 and 75 years (inclusive, at randomization).
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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.
- 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.
- 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.
- Subject (or care giver) is able to properly prepare and administer study medication.
- Subject is willing and able to give written informed consent to participate.
Exclusion Criteria:
- Subject has had a COPD exacerbation or lung infection within 6 weeks before randomization.
- 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.
- Subject is taking daily maintenance inhaled/systemic corticosteroids (>1000 μg of fluticasone propionate equivalent or ≥10 mg prednisone).
- 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.
- 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.
- Subject has a known hypersensitivity to TD-4208 or similar drug class.
- Subject has a history of alcoholism or drug abuse within 2 years prior to screening.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704404
New Zealand | |
P3 Research Ltd | |
Wellington, New Zealand |
Study Director: | Medical Monitor | Theravance Biopharma |
Responsible Party: | Mylan Inc. |
ClinicalTrials.gov Identifier: | NCT01704404 |
Other Study ID Numbers: |
0091 |
First Posted: | October 11, 2012 Key Record Dates |
Results First Posted: | March 13, 2017 |
Last Update Posted: | February 24, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Long acting muscarinic antagonist Chronic Bronchitis Emphysema Chronic Obstructive Pulmonary Disease COPD |
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |