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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
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

Study type
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

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

Key inclusion criteria
1. Subject is a male or female between the ages of 40 and 75 years (inclusive, at

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Subject has had a COPD exacerbation or lung infection within 6 weeks before

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

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

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
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
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Theravance Biopharma

Ethics approval
Ethics application status

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
Trial related presentations / publications
Public notes

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

Summary results
Other publications