Trial Outcomes & Findings for A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) TD-4208 in Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT02109172)
NCT ID: NCT02109172
Last Updated: 2022-02-24
Results Overview
Weighted mean (0-24hr) Change from baseline FEV1 (forced expiratory volume in 1 second). Measurement is change from baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Following the Day 7 AM dose -12 hours post-dose and 24 hours post-dose
Results posted on
2022-02-24
Participant Flow
Participant milestones
| Measure |
Placebo First, Then 44mcg, Then 175mcg
Placebo twice daily for 7 days then 44mcg twice daily for 7 days then 175mcg once daily for 7 days
|
Placebo First, Then 175mcg, Then 44mcg
Placebo twice daily for 7 days then 175mcg once daily for 7 days then 44mcg twice daily for 7 days
|
44mcg First, Then 175mcg, Then Placebo
44mcg twice daily for 7 days then 175mcg once daily for 7 days then placebo twice daily for 7 days
|
44mcg First, Then Placebo, Then 175mcg
44mcg twice daily for 7 days then placebo twice daily for 7 days then 175mcg once daily for 7 days
|
175mcg First, Then 44mcg, Then Placebo
175mcg once daily for 7 days then 44mcg twice daily for 7 days then placebo twice daily for 7 days
|
175mcg First, Then Placebo, Then 44mcg
175mcg once daily for 7 days then placebo twice daily for 7 days then 44mcg twice daily for 7 days
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
10
|
11
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
9
|
10
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo First, Then 44mcg, Then 175mcg
Placebo twice daily for 7 days then 44mcg twice daily for 7 days then 175mcg once daily for 7 days
|
Placebo First, Then 175mcg, Then 44mcg
Placebo twice daily for 7 days then 175mcg once daily for 7 days then 44mcg twice daily for 7 days
|
44mcg First, Then 175mcg, Then Placebo
44mcg twice daily for 7 days then 175mcg once daily for 7 days then placebo twice daily for 7 days
|
44mcg First, Then Placebo, Then 175mcg
44mcg twice daily for 7 days then placebo twice daily for 7 days then 175mcg once daily for 7 days
|
175mcg First, Then 44mcg, Then Placebo
175mcg once daily for 7 days then 44mcg twice daily for 7 days then placebo twice daily for 7 days
|
175mcg First, Then Placebo, Then 44mcg
175mcg once daily for 7 days then placebo twice daily for 7 days then 44mcg twice daily for 7 days
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=64 Participants
All groups were randomized to receive placebo, TD-4208 44mcg twice daily, and TD-4208 175 mcg once daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Following the Day 7 AM dose -12 hours post-dose and 24 hours post-doseWeighted mean (0-24hr) Change from baseline FEV1 (forced expiratory volume in 1 second). Measurement is change from baseline.
Outcome measures
| Measure |
Placebo
n=64 Participants
Placebo inhalation solution twice daily for 7 days
Placebo
|
TD-4208 44 mcg Twice Daily
n=64 Participants
TD-4208 inhalation solution 44 mcg twice daily for 7 days
TD-4208
|
TD-4208 175 mcg Once Daily
n=64 Participants
TD-4208 inhalation solution 175 mcg once daily, placebo once daily
TD-4208
Placebo
|
|---|---|---|---|
|
Weighted Mean (0-24hr) Change From Baseline FEV1 (Forced Expiratory Volume in 1 Second)
|
-14.4 mL
Standard Error 15.29
|
90.2 mL
Standard Error 15.00
|
98.5 mL
Standard Error 15.03
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
TD-4208 44mcg Twice Daily
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
TD-4208 175mcg Once Daily
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=64 participants at risk
Placebo inhalation solution twice daily for 7 days
|
TD-4208 44mcg Twice Daily
n=64 participants at risk
TD-4208 inhalation solution 44 mcg twice daily for 7 days
|
TD-4208 175mcg Once Daily
n=64 participants at risk
TD-4208 inhalation solution 175 mcg once daily
|
|---|---|---|---|
|
Cardiac disorders
Coronary Artery Insufficiency
|
0.00%
0/64
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=64 participants at risk
Placebo inhalation solution twice daily for 7 days
|
TD-4208 44mcg Twice Daily
n=64 participants at risk
TD-4208 inhalation solution 44 mcg twice daily for 7 days
|
TD-4208 175mcg Once Daily
n=64 participants at risk
TD-4208 inhalation solution 175 mcg once daily
|
|---|---|---|---|
|
Vascular disorders
Blood Pressure Increased
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
|
Respiratory, thoracic and mediastinal disorders
Breath sounds abnormal
|
3.1%
2/64 • Number of events 2
|
0.00%
0/64
|
0.00%
0/64
|
|
Respiratory, thoracic and mediastinal disorders
Chest Discomfort
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
|
Injury, poisoning and procedural complications
Contusion
|
1.6%
1/64 • Number of events 1
|
3.1%
2/64 • Number of events 2
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
1/64 • Number of events 1
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/64
|
0.00%
0/64
|
3.1%
2/64 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/64
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/64
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.7%
3/64 • Number of events 3
|
1.6%
1/64 • Number of events 1
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
Ear Infection
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
|
Injury, poisoning and procedural complications
Eye Swelling
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
|
Gastrointestinal disorders
Gingival pain
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
0.00%
0/64
|
|
General disorders
Oedema
|
0.00%
0/64
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
|
Nervous system disorders
Headache
|
1.6%
1/64 • Number of events 1
|
3.1%
2/64 • Number of events 2
|
1.6%
1/64 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/64
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/64
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
0.00%
0/64
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
0.00%
0/64
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
0.00%
0/64
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
0.00%
0/64
|
|
Nervous system disorders
Tremor
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
|
Infections and infestations
Urinary tract infection
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
0.00%
0/64
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/64
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
0.00%
0/64
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
0.00%
0/64
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
|
Vascular disorders
Coronary artery insufficiency
|
0.00%
0/64
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
0.00%
0/64
|
|
Infections and infestations
Furuncle
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
|
Investigations
Haemoglobin decreased
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
0.00%
0/64
|
|
Vascular disorders
Hypertension
|
0.00%
0/64
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
0.00%
0/64
|
|
General disorders
Oedema peripheral
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
0.00%
0/64
|
|
Infections and infestations
Oral candidiasis
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
0.00%
0/64
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
0.00%
0/64
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
0.00%
0/64
|
Additional Information
Head of Clinical Development & Medical Affairs
Theravance Biopharma
Phone: 1-855-633-8479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PI may communicate the trial results generated by the PI, but only after the first publication or presentation of the combined study results generated by all participating sites. The Sponsor can then review trial results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The Sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER