Chronic Obstructive Pulmonary Disease, COPDPhase 2NCT03064113
Effects of TD-4208 on FEV1 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing TD-4208 700 μg, TD-4208 350 μg and Ipratropium 500 μg in people with Chronic Obstructive Pulmonary Disease, COPD, run by Mylan Inc. at 1 site in New Zealand.
Trial summary
Thirty-two subjects diagnosed with COPD were enrolled, received each study treatment and completed the follow-up assessments. During each of the four study periods, subjects were admitted to the clinic on Day -1 and housed overnight until after the last spirometry measurement. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD
- What is being tested?
- TD-4208 700 μg, TD-4208 350 μg and Ipratropium 500 μg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteNew Zealand
- Study dates
- May 2011to Oct 2011
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of moderate stable Chronic Obstructive Pulmonary.
- Disease with FEV1/FVC <0.7 at screening.
- Woman of non-childbearing potential.
- Female participants of childbearing potential must test negative for pregnancy and must be using a highly effective method of birth control during the study and for at least 1 month after completion of study dosing.
- Female participants must not be breastfeeding.
- Men 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.
- Current or past smoking history >10 pack-years.
- Must be capable of performing reproducible spirometry maneuvers.
Who cannot join
- History of significant respiratory disease other than COPD, and/ or requires daily long-term oxygen therapy.
- Exacerbation of COPD, lung infection within 6 weeks prior to study.
- Start of or change in dose of COPD treatment 4 weeks before study.
- Daily using of maintenance systemic/inhaled corticosteroids (>1000 microgram of fluticasone propionate equivalent or >5 mg prednisone).
- Use of bronchodilators or medication for the treatment of COPD, aspirin, anti-inflammatories for a specific time, prior to the first dose or is not willing to abstain from their use for the specified time periods prior to study dose administration.
- Symptomatic prostrate hypertrophy, bladder neck obstruction, active cancer, narrow angle glaucoma.
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- Clinical significant hypersensitivity to medications.
- Participants have an uncontrolled hematologic, immunologic, renal, neurologic, hepatic, endocrine or other disease that may place participant at risk.
- Cerebrovascular, cardiovascular disease or abnormal ECG.
- History of drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Randomized, Double-Blind, Crossover Study to Examine the Pharmacodynamics, Safety and Tolerability, and Pharmacokinetics of Single Doses of TD-4208 in Subjects Diagnosed With Chronic Obstructive Pulmonary Disease
Thirty-two subjects diagnosed with COPD were enrolled, received each study treatment and completed the follow-up assessments. During each of the four study periods, subjects were admitted to the clinic on Day -1 and housed overnight until after the last spirometry measurement. Serial pulmonary function tests were performed and PK (pharmacokinetics) samples collected up to 25 hours. Subjects were discharged from the clinic on Day 2 after evaluations.
Read the detailed description
Subjects were assigned to one of the 4-treatment sequence groups presented in the table above according to a randomization schedule supplied by the Sponsor before study initiation. The randomization scheme did not include assignments for replacement subjects.
Subjects reported to their respective clinical research unit (CRU) on Admission/Day -1 for pre-randomization procedures and confirmation of eligibility (and continued eligibility for Periods 2 to 4). The unblinded pharmacist prepared and dispensed the nebulizers, according to the randomization schedule for each of the 4 periods. Dosing occurred in the morning, generally between 7 am and 9 am. For Periods 2 to 4, dosing occurred within ±30 minutes of the dosing time established in Period 1.
Study drug was administered in the respective CRU under the supervision of study personnel. Single doses of TD-4208, ipratropium bromide, and placebo were administered in the clinical research unit (CRU) under the supervision of study personnel. Care was taken to avoid eye contact with study drugs. Residual drug solution remaining in the nebulizer (ie, in mL) was measured and recorded.
The investigator or designee was responsible for maintaining accountability records for all study drug(s) in accordance with applicable government regulations and study procedures.
The accountability record included entries for receipt, distribution or dispensing, and destruction of the material(s). Unused and expired study drugs were to be disposed of in accordance with written instructions from the Sponsor.
- Being tested
- Placebo, TD-4208 700 μg, TD-4208 350 μg, Ipratropium 500 μg
- 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.
PlaceboDrug
TD-4208 700 μgDrug
Also called Revefenacin
TD-4208 350 μgDrug
Also called Revefenacin
Ipratropium 500 μgDrug
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Period 1 = Placebo; Period 2 = TD-4208 700 μg; Period 3 = TD-4208 350 μg; Period 4 = Ipratropium 500 μg Receives: Drug: Placebo; Drug: TD-4208 700 μg; Drug: TD-4208 350 μg; Drug: Ipratropium 500 μg |
| Sequence 2 | Experimental | Period 1 = TD-4208 700 μg; Period 2 = Ipratropium 500 μg; Period 3 = Placebo; Period 4 = TD-4208 350 μg Receives: Drug: Placebo; Drug: TD-4208 700 μg; Drug: TD-4208 350 μg; Drug: Ipratropium 500 μg |
| Sequence 3 | Experimental | Period 1 = TD-4208 350 μg; Period 2 = Placebo; Period 3 = Ipratropium 500 μg; Period 4 = TD-4208 700 μg Receives: Drug: Placebo; Drug: TD-4208 700 μg; Drug: TD-4208 350 μg; Drug: Ipratropium 500 μg |
| Sequence 4 | Experimental | Period 1 = Ipratropium 500 μg; Period 2 = TD-4208 350 μg; Period 3 = TD-4208 700 μg; Period 4 = Placebo Receives: Drug: Placebo; Drug: TD-4208 700 μg; Drug: TD-4208 350 μg; Drug: Ipratropium 500 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Forced Expiratory Volume in One Second (FEV1) Relative to Baseline
Measured: From predose to 25 hours postdose
Secondary outcomes (6)
Area Under the FEV1 vs. Time Curve, Time-matched Difference From Placebo
Measured: 12 hr and 24 hr
Area Under the FEV1 vs. Peak FEV1, Time-matched Difference From Placebo
Measured: 12 hr and 24 hr
Peak Expiratory Flow Rate (PEFR) From 25% to 75% of Vital Capacity (FEF25-75), as Related to FEV1
Measured: 12hr and 24hr
Forced Expiratory Flow From 25% to 75% of Vital Capacity (FEF25-75), as Related to FEV1
Measured: 12hr and 24hr
Forced Vital Capacity (FVC)
Measured: From predose to 25 hours postdose
Area Under the Forced Vital Capacity (FVC) vs. Time Curve
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study startMay 2011
- Primary completionOct 2011
- Study completionOct 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease, COPDStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064113
- Sponsor's protocol ID
- 0059
- Other IDs
- ACTRN12611000482965, U1111-1120-8290
- Status last verified
- Feb 2022
- First submitted
- 20 Jan 2017
- Last updated
- 24 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lo A, Borin MT, Bourdet DL. Population Pharmacokinetics of Revefenacin in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2021 Mar;60(3):391-401. doi: 10.1007/s40262-020-00938-3.
PubMed 33124005
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, Crossover Study to Examine the Pharmacodynamics, Safety and Tolerability, and Pharmacokinetics of Single Doses of TD-4208 in Subjects Diagnosed With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03064113
- Acronym / sponsor ID
- 0059
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mylan Inc.Industry (pharma, biotech, devices)
- Collaborators
- Theravance Biopharma
- Study start
- May 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Posted 14 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thirty-two subjects diagnosed with COPD were enrolled, received each study treatment and completed the follow-up assessments. During each of the four study periods, subjects were admitted to the clinic on Day -1 and housed overnight until after the last spirometry measurement. Serial pulmonary function tests were performed and PK (pharmacokinetics) samples collected up to 25 hours. Subjects were discharged from the clinic on Day 2 after evaluations.
Detailed description
Subjects were assigned to one of the 4-treatment sequence groups presented in the table above according to a randomization schedule supplied by the Sponsor before study initiation. The randomization scheme did not include assignments for replacement subjects.
Subjects reported to their respective clinical research unit (CRU) on Admission/Day -1 for pre-randomization procedures and confirmation of eligibility (and continued eligibility for Periods 2 to 4). The unblinded pharmacist prepared and dispensed the nebulizers, according to the randomization schedule for each of the 4 periods. Dosing occurred in the morning, generally between 7 am and 9 am. For Periods 2 to 4, dosing occurred within ±30 minutes of the dosing time established in Period 1.
Study drug was administered in the respective CRU under the supervision of study personnel. Single doses of TD-4208, ipratropium bromide, and placebo were administered in the clinical research unit (CRU) under the supervision of study personnel. Care was taken to avoid eye contact with study drugs. Residual drug solution remaining in the nebulizer (ie, in mL) was measured and recorded.
The investigator or designee was responsible for maintaining accountability records for all study drug(s) in accordance with applicable government regulations and study procedures.
The accountability record included entries for receipt, distribution or dispensing, and destruction of the material(s). Unused and expired study drugs were to be disposed of in accordance with written instructions from the Sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Placebo, Drug: TD-4208 700 μg, Drug: TD-4208 350 μg, Drug: Ipratropium 500 μgPeriod 1 = Placebo; Period 2 = TD-4208 700 μg; Period 3 = TD-4208 350 μg; Period 4 = Ipratropium 500 μg |
| Sequence 2 | Experimental | Drug: Placebo, Drug: TD-4208 700 μg, Drug: TD-4208 350 μg, Drug: Ipratropium 500 μgPeriod 1 = TD-4208 700 μg; Period 2 = Ipratropium 500 μg; Period 3 = Placebo; Period 4 = TD-4208 350 μg |
| Sequence 3 | Experimental | Drug: Placebo, Drug: TD-4208 700 μg, Drug: TD-4208 350 μg, Drug: Ipratropium 500 μgPeriod 1 = TD-4208 350 μg; Period 2 = Placebo; Period 3 = Ipratropium 500 μg; Period 4 = TD-4208 700 μg |
| Sequence 4 | Experimental | Drug: Placebo, Drug: TD-4208 700 μg, Drug: TD-4208 350 μg, Drug: Ipratropium 500 μgPeriod 1 = Ipratropium 500 μg; Period 2 = TD-4208 350 μg; Period 3 = TD-4208 700 μg; Period 4 = Placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of moderate stable Chronic Obstructive Pulmonary.
- Disease with FEV1/FVC <0.7 at screening.
- Woman of non-childbearing potential.
- Female participants of childbearing potential must test negative for pregnancy and must be using a highly effective method of birth control during the study and for at least 1 month after completion of study dosing.
- Female participants must not be breastfeeding.
Key exclusion criteria (10 listed)
- History of significant respiratory disease other than COPD, and/ or requires daily long-term oxygen therapy.
- Exacerbation of COPD, lung infection within 6 weeks prior to study.
- Start of or change in dose of COPD treatment 4 weeks before study.
- Daily using of maintenance systemic/inhaled corticosteroids (>1000 microgram of fluticasone propionate equivalent or >5 mg prednisone).
- Use of bronchodilators or medication for the treatment of COPD, aspirin, anti-inflammatories for a specific time, prior to the first dose or is not willing to abstain from their use for the specified time periods prior to study dose administration.
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 |
|---|---|---|
| Placebo | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| TD-4208 700 μgAlso: Revefenacin | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| TD-4208 350 μgAlso: Revefenacin | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Ipratropium 500 μg | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
Primary outcome
Peak Forced Expiratory Volume in One Second (FEV1) Relative to Baseline
Time frame: From predose to 25 hours postdose
6 secondary outcomes
Area Under the FEV1 vs. Time Curve, Time-matched Difference From Placebo
Time frame: 12 hr and 24 hr
Area Under the FEV1 vs. Peak FEV1, Time-matched Difference From Placebo
Time frame: 12 hr and 24 hr
Peak Expiratory Flow Rate (PEFR) From 25% to 75% of Vital Capacity (FEF25-75), as Related to FEV1
Time frame: 12hr and 24hr
Forced Expiratory Flow From 25% to 75% of Vital Capacity (FEF25-75), as Related to FEV1
Time frame: 12hr and 24hr
Forced Vital Capacity (FVC)
Time frame: From predose to 25 hours postdose
Area Under the Forced Vital Capacity (FVC) vs. Time Curve
Time frame: 0-24 hours
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.
- Derived from this study: PubMed 33124005Lo A, Borin MT, Bourdet DL. Population Pharmacokinetics of Revefenacin in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2021 Mar;60(3):391-401. doi: 10.1007/s40262-020-00938-3.
- 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
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 700 μg, TD-4208 350 μg and Ipratropium 500 μg in people with Chronic Obstructive Pulmonary Disease, COPD, run by Mylan Inc. at 1 site in New Zealand.
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 8 inclusion and 10 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 New Zealand. 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. 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 14 Nov 2019). 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?
Peak Forced Expiratory Volume in One Second (FEV1) Relative to Baseline (time frame: From predose to 25 hours postdose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03064113, which also lists 1 linked publication.
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.