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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03064113




Registration number
NCT03064113
Ethics application status
Date submitted
20/01/2017
Date registered
24/02/2017

Titles & IDs
Public title
Effects of TD-4208 on FEV1 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Scientific 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
Secondary ID [1] 0 0
ACTRN12611000482965
Secondary ID [2] 0 0
0059
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease, COPD 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Sequence 1 - Period 1 = Placebo; Period 2 = TD-4208 700 µg; Period 3 = TD-4208 350 µg; Period 4 = Ipratropium 500 µg

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

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

Experimental: Sequence 4 - Period 1 = Ipratropium 500 µg; Period 2 = TD-4208 350 µg; Period 3 = TD-4208 700 µg; Period 4 = Placebo
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Peak Forced Expiratory Volume in One Second (FEV1) Relative to Baseline
Timepoint [1] 0 0
From predose to 25 hours postdose
Secondary outcome [1] 0 0
Area Under the FEV1 vs. Time Curve, Time-matched Difference From Placebo
Timepoint [1] 0 0
12 hr and 24 hr
Secondary outcome [2] 0 0
Area Under the FEV1 vs. Peak FEV1, Time-matched Difference From Placebo
Timepoint [2] 0 0
12 hr and 24 hr
Secondary outcome [3] 0 0
Peak Expiratory Flow Rate (PEFR) From 25% to 75% of Vital Capacity (FEF25-75), as Related to FEV1
Timepoint [3] 0 0
12hr and 24hr
Secondary outcome [4] 0 0
Forced Expiratory Flow From 25% to 75% of Vital Capacity (FEF25-75), as Related to FEV1
Timepoint [4] 0 0
12hr and 24hr
Secondary outcome [5] 0 0
Forced Vital Capacity (FVC)
Timepoint [5] 0 0
From predose to 25 hours postdose
Secondary outcome [6] 0 0
Area Under the Forced Vital Capacity (FVC) vs. Time Curve
Timepoint [6] 0 0
0-24 hours

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Mylan Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Theravance Biopharma
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Theravance Biopharma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03064113