We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01704404
First Posted: October 11, 2012
Last Update Posted: June 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Theravance Biopharma R & D, Inc.
  Purpose
This study will characterize the dose response of TD-4208 after 7 days of dosing in subjects with Chronic Obstructive Pulmonary Disease (COPD).

Condition Intervention Phase
COPD Drug: TD-4208 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Theravance Biopharma R & D, Inc.:

Primary Outcome Measures:
  • Change From Baseline to Day 7 in Trough FEV1 (Forced Expiratory Volume in 1 Second) [ Time Frame: From baseline to day 7 ]

Other Outcome Measures:
  • 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.



Enrollment: 62
Study Start Date: December 2012
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
New Zealand
P3 Research Ltd
Wellington, New Zealand
Sponsors and Collaborators
Theravance Biopharma R & D, Inc.
Investigators
Study Director: Glenn Crater, M.D. Theravance Biopharma, US, Inc.
  More Information

Responsible Party: Theravance Biopharma R & D, Inc.
ClinicalTrials.gov Identifier: NCT01704404     History of Changes
Other Study ID Numbers: 0091
First Submitted: October 4, 2012
First Posted: October 11, 2012
Results First Submitted: January 17, 2017
Results First Posted: March 13, 2017
Last Update Posted: June 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Theravance Biopharma R & D, Inc.:
Long acting muscarinic antagonist
Chronic Bronchitis
Emphysema
Chronic Obstructive Pulmonary Disease
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases


To Top