A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
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ClinicalTrials.gov Identifier: NCT02109172 |
Recruitment Status :
Completed
First Posted : April 9, 2014
Results First Posted : December 8, 2016
Last Update Posted : February 24, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease COPD | Drug: TD-4208 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Cross-Over Study of QD and BID Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease |
Study Start Date : | April 2014 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | October 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: TD-4208 44 mcg twice daily
TD-4208 inhalation solution 44 mcg twice daily for 7 days
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Drug: TD-4208
Other Name: Revefenacin |
Placebo Comparator: Placebo
Placebo inhalation solution twice daily for 7 days
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Drug: Placebo |
Experimental: TD-4208 175 mcg once daily
TD-4208 inhalation solution 175 mcg once daily, placebo once daily
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Drug: TD-4208
Other Name: Revefenacin Drug: Placebo |
- Weighted Mean (0-24hr) Change From Baseline FEV1 (Forced Expiratory Volume in 1 Second) [ Time Frame: Following the Day 7 AM dose -12 hours post-dose and 24 hours post-dose ]Weighted mean (0-24hr) Change from baseline FEV1 (forced expiratory volume in 1 second). Measurement is change from baseline.

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject must have a negative pregnancy test, and must be prepared to use effective contraception if of child-bearing potential
- Subject is capable of performing reproducible spirometry maneuvers
- Subject has post-bronchodilator FEV1/FVC (forced expiratory volume in 1 second/forced vital capacity) ratio <0.7
- Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the Global Initiative for the Treatment of Obstructive Lung Disease (GOLD) Guidelines)
- Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal
- Subject demonstrates a post-ipratropium FEV1 response ≥ 12% and ≥ 200 mL of pre-ipratropium FEV1 response
- Subject has a current or past smoking history of at least 10 pack-years.
Exclusion Criteria:
- Subject has a significant respiratory disease or disorder other than COPD that would affect the interpretation of data from this study
- Subject has a history of reactions or hypersensitivity to inhaled anticholinergic or beta-agonist agents
- Subject suffers from any medical condition that would preclude the use of inhaled anticholinergic agents
- Subject has been hospitalized for COPD or pneumonia within 12 weeks.
- Subject requires long-term oxygen therapy (>15 hours a day)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109172
United States, North Carolina | |
American Health Research | |
Charlotte, North Carolina, United States, 28207 |
Study Director: | Medical Monitor | Theravance Biopharma, US, Inc. |
Responsible Party: | Mylan Inc. |
ClinicalTrials.gov Identifier: | NCT02109172 |
Other Study ID Numbers: |
0116 |
First Posted: | April 9, 2014 Key Record Dates |
Results First Posted: | December 8, 2016 |
Last Update Posted: | February 24, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Chronic Obstructive Pulmonary Disease COPD |
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |