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Trial record 69 of 150 for:    Ipratropium OR atrovent

Effects of TD-4208 on FEV1 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT03064113
Recruitment Status : Completed
First Posted : February 24, 2017
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

Brief Summary:
Thirty-two subjects diagnosed with COPD were enrolled, received each study treatment and completed the follow-up assessments. During each of the four study periods, subjects were admitted to the clinic on Day -1 and housed overnight until after the last spirometry measurement. Serial pulmonary function tests were performed and PK (pharmacokinetics) samples collected up to 25 hours. Subjects were discharged from the clinic on Day 2 after evaluations.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease, COPD Drug: Placebo Drug: TD-4208 700 μg Drug: TD-4208 350 μg Drug: Ipratropium 500 μg Phase 2

Detailed Description:

Subjects were assigned to one of the 4-treatment sequence groups presented in the table above according to a randomization schedule supplied by the Sponsor before study initiation. The randomization scheme did not include assignments for replacement subjects.

Subjects reported to their respective clinical research unit (CRU) on Admission/Day −1 for pre-randomization procedures and confirmation of eligibility (and continued eligibility for Periods 2 to 4). The unblinded pharmacist prepared and dispensed the nebulizers, according to the randomization schedule for each of the 4 periods. Dosing occurred in the morning, generally between 7 am and 9 am. For Periods 2 to 4, dosing occurred within ±30 minutes of the dosing time established in Period 1.

Study drug was administered in the respective CRU under the supervision of study personnel. Single doses of TD-4208, ipratropium bromide, and placebo were administered in the clinical research unit (CRU) under the supervision of study personnel. Care was taken to avoid eye contact with study drugs. Residual drug solution remaining in the nebulizer (ie, in mL) was measured and recorded.

The investigator or designee was responsible for maintaining accountability records for all study drug(s) in accordance with applicable government regulations and study procedures.

The accountability record included entries for receipt, distribution or dispensing, and destruction of the material(s). Unused and expired study drugs were to be disposed of in accordance with written instructions from the Sponsor.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Crossover Study to Examine the Pharmacodynamics, Safety and Tolerability, and Pharmacokinetics of Single Doses of TD-4208 in Subjects Diagnosed With Chronic Obstructive Pulmonary Disease
Study Start Date : May 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Placebo Comparator: Placebo

Sequence 1:

Period 1 = Placebo; Period 2 = TD-4208 700 μg; Period 3 = TD-4208 350 μg; Period 4 = Ipratropium 500 μg

Drug: Placebo
Drug: TD-4208 700 μg
Other Name: Revefenacin

Drug: TD-4208 350 μg
Other Name: Revefenacin

Drug: Ipratropium 500 μg
Experimental: TD-4208 700 μg

Sequence 2:

Period 1 = TD-4208 700 μg; Period 2 = Ipratropium 500 μg; Period 3 = Placebo; Period 4 = TD-4208 350 μg

Drug: Placebo
Drug: TD-4208 700 μg
Other Name: Revefenacin

Drug: TD-4208 350 μg
Other Name: Revefenacin

Drug: Ipratropium 500 μg
Experimental: TD-4208 350 μg

Sequence 3:

Period 1 = TD-4208 350 μg; Period 2 = Placebo; Period 3 = Ipratropium 500 μg; Period 4 = TD-4208 700 μg

Drug: Placebo
Drug: TD-4208 700 μg
Other Name: Revefenacin

Drug: TD-4208 350 μg
Other Name: Revefenacin

Drug: Ipratropium 500 μg
Active Comparator: Ipratropium 500 μg

Sequence 4:

Period 1 = Ipratropium 500 μg; Period 2 = TD-4208 350 μg; Period 3 = TD-4208 700 μg; Period 4 = Placebo

Drug: Placebo
Drug: TD-4208 700 μg
Other Name: Revefenacin

Drug: TD-4208 350 μg
Other Name: Revefenacin

Drug: Ipratropium 500 μg



Primary Outcome Measures :
  1. Change in peak forced expiratory volume in one second (FEV1) relative to baseline [ Time Frame: From predose to 25 hours postdose ]

Secondary Outcome Measures :
  1. Area under the FEV1 vs. time curve, time-matched difference from placebo [ Time Frame: From predose to 25 hours postdose ]
  2. Area under the FEV1 vs. peak FEV1, time-matched difference from placebo [ Time Frame: From predose to 25 hours postdose ]
  3. Peak Expiratory Flow Rate (PEFR) from 25% to 75% of vital capacity (FEF25−75), as related to FEV1 [ Time Frame: From predose to 25 hours postdose ]
  4. Forced Expiratory flow from 25% to 75% of vital capacity (FEF25−75), as related to FEV1 [ Time Frame: From predose to 25 hours postdose ]
  5. Forced Vital Capacity (FVC) [ Time Frame: From predose to 25 hours postdose ]
  6. Area under the forced vital capacity (FVC) vs. time curve [ Time Frame: From predose to 25 hours postdose ]
  7. Safety and tolerability endpoints: adverse events [ Time Frame: From randomization to the Period 4 Post-Study Follow-up Visit (up to 84 days) ]
  8. Safety and tolerability endpoints: vital signs [ Time Frame: From predose to 24 hours postdose ]
  9. Safety and tolerability endpoints: ECG parameters [ Time Frame: From predose to 24 hours postdose ]
  10. Safety and tolerability endpoints: physical exam results [ Time Frame: From predose to 24 hours postdose ]
  11. Safety and tolerability endpoints: clinical lab results [ Time Frame: From predose to 24 hours postdose ]
  12. Plasma PK parameters: Cmax [ Time Frame: From predose to 24 hours postdose ]
  13. Plasma PK parameters: Area under the concentration-versus-time curve calculated from time zero to the last detectable time point (AUC0-t) [ Time Frame: From predose to 24 hours postdose ]
  14. Plasma PK parameters: terminal half-life (t½) [ Time Frame: From predose to 24 hours postdose ]
  15. Plasma PK parameters: Renal clearance calculated as Ae/AUC0-t (CLrenal) [ Time Frame: From predose to 24 hours postdose ]
  16. Urine PK parameters: Cmax [ Time Frame: From predose to 24 hours postdose ]
  17. Urine PK parameters: Area under the concentration-versus-time curve calculated from time zero to the last detectable time point (AUC0-t) [ Time Frame: From predose to 24 hours postdose ]
  18. Urine PK parameters: terminal half-life (t½) [ Time Frame: From predose to 24 hours postdose ]
  19. Urine PK parameters: Renal clearance calculated as Ae/AUC0-t (CLrenal) [ Time Frame: From predose to 24 hours postdose ]
  20. Metabolite profiling performed using plasma and urine samples [ Time Frame: From predose to 24 hours postdose ]
  21. Pharmacokinetic parameters (including Time to maximum concentration [Tmax]) [ Time Frame: From predose to 24 hours postdose ]
  22. Observed maximum concentration (Cmax) [ Time Frame: From predose to 24 hours postdose ]
  23. Elimination half-life (t1/2) [ Time Frame: From predose to 24 hours postdose ]
  24. Area Under the Concentration-time curve (AUC) for TD-4208 in blood [ Time Frame: From predose to 24 hours postdose ]
  25. Area Under the Concentration-time curve (AUC) for TD-4208 in urine [ Time Frame: From predose to 24 hours postdose ]


Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • Diagnosis of moderate stable Chronic Obstructive Pulmonary.
  • Disease with FEV1/FVC <0.7 at screening.
  • Woman of non-childbearing potential.
  • Female participants of childbearing potential must test negative for pregnancy and must be using a highly effective method of birth control during the study and for at least 1 month after completion of study dosing.
  • Female participants must not be breastfeeding.
  • Men 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.
  • Current or past smoking history >10 pack-years.
  • Must be capable of performing reproducible spirometry maneuvers.

Exclusion Criteria:

  • History of significant respiratory disease other than COPD, and/ or requires daily long-term oxygen therapy.
  • Exacerbation of COPD, lung infection within 6 weeks prior to study.
  • Start of or change in dose of COPD treatment 4 weeks before study.
  • Daily using of maintenance systemic/inhaled corticosteroids (>1000 microgram of fluticasone propionate equivalent or >5 mg prednisone).
  • Use of bronchodilators or medication for the treatment of COPD, aspirin, anti-inflammatories for a specific time, prior to the first dose or is not willing to abstain from their use for the specified time periods prior to study dose administration.
  • Symptomatic prostrate hypertrophy, bladder neck obstruction, active cancer, narrow angle glaucoma.
  • Clinical significant hypersensitivity to medications.
  • Participants have an uncontrolled hematologic, immunologic, renal, neurologic, hepatic, endocrine or other disease that may place participant at risk.
  • Cerebrovascular, cardiovascular disease or abnormal ECG.
  • History of drug or alcohol abuse.

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): NCT03064113


Locations
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New Zealand
P3 Research
Wellington, New Zealand, 6021
Sponsors and Collaborators
Theravance Biopharma
Investigators
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Study Director: Glenn Crater, M.D. Theravance Biopharma, US, Inc.

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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT03064113     History of Changes
Other Study ID Numbers: 0059
ACTRN12611000482965 ( Registry Identifier: ANZCTR )
U1111-1120-8290 ( Other Identifier: Universal Trial Number )
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Keywords provided by Theravance Biopharma:
Chronic Obstructive Pulmonary Disease, COPD
Additional relevant MeSH terms:
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Ipratropium
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action