Chronic Obstructive Pulmonary Disease (COPD)Phase 1NCT01921712
A Safety, Pharmacokinetic and Pharmacodynamic Study of PUR0200 in COPD Patients
A Phase 1 study testing PUR0200 and Active comparator in people with Chronic Obstructive Pulmonary Disease (COPD), run by Pulmatrix Inc. at 2 sites in United Kingdom.
Trial summary
The purpose of this study is to assess the safety and tolerability of PUR0200. In addition, the study will look at the blood levels of different doses of PUR0200 and their affect on lung function in COPD patients. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- PUR0200 and Active comparator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jul 2013to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical diagnosis of moderate to severe COPD according to the following criteria:
- Current or ex-smokers with at least 10 pack-year smoking history
- Post-bronchodilator FEV1 >/= 35% and </= 80% of predicted normal value
- Post-bronchodilator FEV1/FVC (forced vital capacity) ratio <0.70
- Post-bronchodilator improvement in FEV1 >/= 100 mL
Who cannot join
- Current evidence or recent history of clinically significant or unstable disease (other than COPD)
- Current diagnosis of asthma
- Presence of history of clinically significant allergy requiring treatment
- COPD exacerbation within 6 weeks
- Use of daily oxygen therapy > 10 hours
- Thoracotomy with pulmonary resection
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- Use of systemic steroids within 3 months
- Lower respiratory tract infection within 30 days
- Upper respiratory tract infection within 30 days requiring treatment with antibiotics
- History of tuberculosis, bronchiectasis, or other non-specific pulmonary disease
- Prolonged corrected QT (QTc) interval >450 msec males and >470 msec females, or history of long QT syndrome
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Medicines Evaluation Unit
Manchester, M23 9QZ
Quotient Clinical
Nottingham, NG11 6JS
About this study
Official title: A Phase I, 2-Part, Single-dose, Placebo and Active-Controlled, Dose-ranging, Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to assess the safety and tolerability of PUR0200. In addition, the study will look at the blood levels of different doses of PUR0200 and their affect on lung function in COPD patients.
Read the detailed description
This is a multi-center, 2-part, pharmacokinetic (PK), pharmacodynamic (PD) effect, safety and tolerability study of single doses of PUR0200.
- Being tested
- PUR0200, PUR0200 Placebo, Active comparator
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease
- 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.
PUR0200Drug
Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator
PUR0200 PlaceboDrug
Randomized, single dose of inhaled placebo matched to PUR0200
Active comparatorDrug
Randomized single dose of inhaled active comparator product
| Study group | Role | What they receive |
|---|---|---|
| PUR0200 low dose | Experimental | PUR0200 low dose, single dose inhalation Receives: Drug: PUR0200 |
| PUR0200 mid dose | Experimental | PUR0200 mid dose, single dose inhalation Receives: Drug: PUR0200 |
| PUR0200 high dose | Experimental | PUR0200 high dose, single dose inhalation Receives: Drug: PUR0200 |
| Placebo | Placebo comparator | PUR0200 matched placebo, single dose, inhalation Receives: Drug: PUR0200 Placebo |
| Active Comparator | Active comparator | Active Comparator, single dose, inhalation Receives: Drug: Active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax) of PUR0200
Measured: 0 to 24 hours
Time to reach peak plasma (Tmax) concentration of PUR0200
Measured: 0 to 24 hours
Area under the plasma concentration versus time (AUC) of PUR0200
Measured: 0 to 24 hours
Trough forced expiratory volume in 1 second (FEV1)
Measured: 24 hours
Trough FEV1 difference from baseline
Measured: 24 hours
Number of participants with adverse events
adverse events, vital signs, clinical laboratory changes, and ECG changes will be evaluated
Measured: up to 14 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmatrix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Responsible party
- Sponsor
- Investigators
- David Hava, Ph.D., Study director, Pulmatrix Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921712
- Sponsor's protocol ID
- 601-0010P
- Status last verified
- Mar 2014
- First submitted
- 9 Aug 2013
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, 2-Part, Single-dose, Placebo and Active-Controlled, Dose-ranging, Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01921712
- Acronym / sponsor ID
- 601-0010P
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Pulmatrix Inc.Industry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability of PUR0200. In addition, the study will look at the blood levels of different doses of PUR0200 and their affect on lung function in COPD patients.
Detailed description
This is a multi-center, 2-part, pharmacokinetic (PK), pharmacodynamic (PD) effect, safety and tolerability study of single doses of PUR0200.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PUR0200 low dose | Experimental | Drug: PUR0200PUR0200 low dose, single dose inhalation |
| PUR0200 mid dose | Experimental | Drug: PUR0200PUR0200 mid dose, single dose inhalation |
| PUR0200 high dose | Experimental | Drug: PUR0200PUR0200 high dose, single dose inhalation |
| Placebo | Placebo comparator | Drug: PUR0200 PlaceboPUR0200 matched placebo, single dose, inhalation |
| Active Comparator | Active comparator | Drug: Active comparatorActive Comparator, single dose, inhalation |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A clinical diagnosis of moderate to severe COPD according to the following criteria:
Key exclusion criteria (11 listed)
- Current evidence or recent history of clinically significant or unstable disease (other than COPD)
- Current diagnosis of asthma
- Presence of history of clinically significant allergy requiring treatment
- COPD exacerbation within 6 weeks
- Use of daily oxygen therapy > 10 hours
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 |
|---|---|---|
| PUR0200Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator | Drug | PUR0200 high dose, PUR0200 low dose, PUR0200 mid dose |
| PUR0200 PlaceboRandomized, single dose of inhaled placebo matched to PUR0200 | Drug | Placebo |
| Active comparatorRandomized single dose of inhaled active comparator product | Drug | Active Comparator |
Primary outcome
Peak plasma concentration (Cmax) of PUR0200
Time frame: 0 to 24 hours
Time to reach peak plasma (Tmax) concentration of PUR0200
Time frame: 0 to 24 hours
Area under the plasma concentration versus time (AUC) of PUR0200
Time frame: 0 to 24 hours
Trough forced expiratory volume in 1 second (FEV1)
Time frame: 24 hours
Trough FEV1 difference from baseline
Time frame: 24 hours
Number of participants with adverse events
Time frame: up to 14 days post-dose
adverse events, vital signs, clinical laboratory changes, and ECG changes will be evaluated
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
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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.
David Hava, Ph.D. study director
Pulmatrix Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PUR0200 and Active comparator in people with Chronic Obstructive Pulmonary Disease (COPD), run by Pulmatrix Inc. at 2 sites in United Kingdom.
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 5 inclusion and 11 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 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 plasma concentration (Cmax) of PUR0200 (time frame: 0 to 24 hours). The study lists 6 primary outcomes in all. 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 18 Mar 2014.