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Trial details imported from ClinicalTrials.gov
Ethics application status
7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
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
Universal Trial Number (UTN)
Chronic obstructive pulmonary disease
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 
Comparator / control treatment
Primary outcome 
Change From Baseline to Day 7 in Trough FEV1 (Forced Expiratory Volume in 1 Second)
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
- 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.
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.
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
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
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Primary sponsor type
Ethics application status
This study will characterize the dose response of TD-4208 after 7 days of dosing in subjects
with Chronic Obstructive Pulmonary Disease (COPD).
Trial related presentations / publications
Glenn Crater, M.D.
Theravance Biopharma, US, Inc.