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Efficacy, Safety and Pharmacokinetics of Multiple Doses of TD−4208 for 7 Days in Subjects With Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
ClinicalTrials.gov Identifier:
NCT01704404
First received: October 4, 2012
Last updated: September 3, 2014
Last verified: September 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Multiple-Dose, Five-Period, Incomplete-Block, Crossover Study to Examine 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 Antibiotics, Inc.:

Primary Outcome Measures:
  • Trough FEV1 after the seventh dose of each treatment period [ Time Frame: From baseline through 35 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart rate [ Time Frame: baseline to day 7 in each treatment period (35 days) ] [ Designated as safety issue: Yes ]
  • Blood Pressure [ Time Frame: baseline to day 7 in each treatment period (35 days) ] [ Designated as safety issue: Yes ]
  • QTcF [ Time Frame: baseline to day 7 in each treatment period (35 days) ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Cmax [ Time Frame: baseline to day 7 in each treatment period (35 days) ] [ Designated as safety issue: No ]
  • Tmax [ Time Frame: baseline to day 7 in each treatment period (35 days) ] [ Designated as safety issue: No ]
  • Plasma half-life [ Time Frame: baseline to day 7 in each treatment period (35 days) ] [ Designated as safety issue: No ]

Enrollment: 60
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
TD-4208
Drug: TD-4208
Experimental: Dose 2 TD-4208
TD-4208
Drug: TD-4208
Experimental: Dose 3 TD-4208
TD-4208
Drug: TD-4208
Experimental: Dose 4 TD-4208
TD-4208
Drug: TD-4208
Experimental: Dose 5 TD-4208
TD-4208
Drug: TD-4208
Experimental: Dose 6 TD-4208
TD-4208
Drug: TD-4208
Experimental: Placebo
Placebo
Drug: Placebo

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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 <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.

    4. Subject is taking daily maintenance inhaled/systemic corticosteroids (>1000 μg of fluticasone propionate equivalent or ≥10 mg prednisone).

    5. 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.

    6. 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 syndrome or has an abnormal clinically significant electrocardiogram (ECG) at screening, including QTcB value >450 msec (males) or >470 msec (females); or shows evidence of clinically significant rhythm abnormality.

    7. Subject has a known hypersensitivity to TD-4208 or similar drug class. 8. Subject has a history of alcoholism or drug abuse within 2 years prior to screening.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01704404

Locations
New Zealand
P3 Research Ltd
Wellington, New Zealand
Sponsors and Collaborators
Theravance Biopharma R & D, Inc.
  More Information

No publications provided

Responsible Party: Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
ClinicalTrials.gov Identifier: NCT01704404     History of Changes
Other Study ID Numbers: 0091
Study First Received: October 4, 2012
Last Updated: September 3, 2014
Health Authority: New Zealand: Medsafe
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Theravance Biopharma Antibiotics, 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

ClinicalTrials.gov processed this record on November 27, 2014