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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01704404




Registration number
NCT01704404
Ethics application status
Date submitted
4/10/2012
Date registered
11/10/2012
Date last updated
24/02/2022

Titles & IDs
Public title
7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
Scientific 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
Secondary ID [1] 0 0
0091
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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
Treatment: Drugs - TD-4208
Treatment: Drugs - Placebo

Experimental: Dose 1 TD-4208 - 22 µg

Experimental: Dose 2 TD-4208 - 44 µg

Experimental: Dose 3 TD-4208 - 88 µg

Experimental: Dose 4 TD-4208 - 175 µg

Experimental: Dose 5 TD-4208 - 350 µg

Experimental: Dose 6 TD-4208 - 700 µg

Placebo Comparator: Placebo - Placebo


Treatment: Drugs: TD-4208


Treatment: Drugs: Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Day 7 in Trough FEV1 (Forced Expiratory Volume in 1 Second)
Timepoint [1] 0 0
From baseline to day 7

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

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
1/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
62
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
This study will characterize the dose response of TD-4208 after 7 days of dosing in subjects
with Chronic Obstructive Pulmonary Disease (COPD).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01704404
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