Chronic Obstructive Pulmonary DiseasePhase 2NCT02109172
A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing TD-4208 in people with Chronic Obstructive Pulmonary Disease and COPD, run by Mylan Inc. at 1 site in United States.
Trial summary
This study evaluated the safety and efficacy of once and twice daily TD-4208 and placebo when administered using a jet nebulizer for 7 days in a cross-over design to patients with moderate to severe chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD
- What is being tested?
- TD-4208
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Oct 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
American Health Research
Charlotte, North Carolina, 28207
About this study
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
This study evaluated the safety and efficacy of once and twice daily TD-4208 and placebo when administered using a jet nebulizer for 7 days in a cross-over design to patients with moderate to severe chronic obstructive pulmonary disease.
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Being tested
- TD-4208, Placebo
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-4208Drug
Also called Revefenacin
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| TD-4208 44 mcg twice daily | Experimental | TD-4208 inhalation solution 44 mcg twice daily for 7 days Receives: Drug: TD-4208 |
| Placebo | Placebo comparator | Placebo inhalation solution twice daily for 7 days Receives: Drug: Placebo |
| TD-4208 175 mcg once daily | Experimental | TD-4208 inhalation solution 175 mcg once daily, placebo once daily Receives: Drug: TD-4208; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weighted Mean (0-24hr) Change From Baseline FEV1 (Forced Expiratory Volume in 1 Second)
Weighted mean (0-24hr) Change from baseline FEV1 (forced expiratory volume in 1 second). Measurement is change from baseline.
Measured: Following the Day 7 AM dose -12 hours post-dose and 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Theravance Biopharma
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Theravance Biopharma, US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109172
- Sponsor's protocol ID
- 0116
- Status last verified
- Feb 2022
- First submitted
- 6 Apr 2014
- Last updated
- 24 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02109172
- Acronym / sponsor ID
- 0116
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mylan Inc.Industry (pharma, biotech, devices)
- Collaborators
- Theravance Biopharma
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Posted 8 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the safety and efficacy of once and twice daily TD-4208 and placebo when administered using a jet nebulizer for 7 days in a cross-over design to patients with moderate to severe chronic obstructive pulmonary disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TD-4208 44 mcg twice daily | Experimental | Drug: TD-4208TD-4208 inhalation solution 44 mcg twice daily for 7 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo inhalation solution twice daily for 7 days |
| TD-4208 175 mcg once daily | Experimental | Drug: TD-4208, Drug: PlaceboTD-4208 inhalation solution 175 mcg once daily, placebo once daily |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TD-4208Also: Revefenacin | Drug | TD-4208 175 mcg once daily, TD-4208 44 mcg twice daily |
| Placebo | Drug | Placebo, TD-4208 175 mcg once daily |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Theravance Biopharma, US, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TD-4208 in people with Chronic Obstructive Pulmonary Disease and COPD, run by Mylan Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.