Chronic Obstructive Pulmonary DiseasePhase 1NCT01333904
Safety, Tolerability, and Pharmacodynamic Effect Study of PUR118
A Phase 1 study testing PUR118 in people with Chronic Obstructive Pulmonary Disease, run by Pulmatrix Inc. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to establish single and multiple dose safety in healthy subjects and subjects with mild chronic pulmonary obstructive disease (COPD). In addition, the study will evaluate preliminary proof of concept endpoints in COPD subjects such as biomarkers in sputum and mucociliary clearance. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- PUR118
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2011to Jun 2012
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Main Inclusion Criteria Parts I \& II
- Healthy males or non pregnant, non lactating healthy females;
- Age 18-65 years of age;
- Must be willing and able to communicate in English and participate in the whole study;
- Must provide written informed consent.
Main Exclusion Criteria Parts I \& II
- Current smokers and those who have smoked within the last 12 months;
- Females of child bearing age not willing to use an acceptable form of contraception;
- Presence or history of allergy requiring treatment;
- Serious adverse reaction or hypersensitivity to any drug;
Main Inclusion Criteria: Parts III and IV
- Males or non pregnant, non lactating females;
- Age 45-70 years;
- Current (Part III only) or ex-smokers who at least a 15 pack-year smoking history. For Part IV, subjects must be non-smokers for at least 3 months;
- Medically stable, with no evidence of uncontrolled co-existing conditions at screening;
- Must not be taking any inhaled or oral corticosteroids;
- FEV1/FVC ratio <70% and FEV1 60 - 80% (or >/= 60% for Part IV only) of predicted following administration of a bronchodilator;
- Patients must have a medical history of COPD confirmed by their General Practitioner (GP) or treating hospital physician or must have a chest x-ray (CXR) which is normal or consistent with mild COPD and excludes other clinically significant respiratory abnormalities;
- Must be willing and able to communicate in English and participate in the whole study;
- Must provide written informed consent.
Main Exclusion Criteria: Parts III and IV
- Must agree to use an adequate method of contraception;
- Upper respiratory tract infection within 30 days of the first study day, or lower respiratory tract infection within the last 60 days;
- Patients taking medication that may affect the respiratory tract within 14 days of the first study day other than their usual COPD medication;
- No active exacerbations requiring antibiotics or steroids within 60 days of dosing.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Bioresearch
Nottingham, United Kingdom, NG11 6JS
About this study
Official title: A Four-Part Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of PUR118 and Placebo in Normal Healthy Volunteers and Subjects With COPD
The purpose of this study is to establish single and multiple dose safety in healthy subjects and subjects with mild chronic pulmonary obstructive disease (COPD). In addition, the study will evaluate preliminary proof of concept endpoints in COPD subjects such as biomarkers in sputum and mucociliary clearance.
Read the detailed description
The proposed initial trial in healthy subjects and subjects with mild COPD will establish the tolerability of PUR118 in these subjects over single and short multi-day dosing periods. The study will also provide preliminary data regarding PUR118's potential impact on biomarkers in COPD. Finally, this trial will assess PUR118's effect on mucociliary clearance. This is a four part study enrolling healthy volunteers in a single ascending dose design (SAD; Part I), followed by multiple ascending dose design (MAD; Part II). Contingent on demonstration of safety in a healthy subject population, the study will enroll mild COPD subjects for a short multi-dose design (Part III) incorporating safety and pharmacodynamic endpoints. Lastly Part IV of the trial will assess the effect of PUR118 on mucociliary clearance in mild COPD subjects.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- PUR118
- 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.
PUR118Drug
inhaled
| Study group | Role | What they receive |
|---|---|---|
| PUR118 | Experimental | Not described Receives: Drug: PUR118 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability assessed by changes in clinical signs and symptoms, clinical safety laboratory tests, vital signs, ECG, spirometry, oxygen saturation, telemetry and adverse events
Measured: 2 weeks
Secondary outcomes (2)
Assessment of biomarkers of inflammation and COPD in induced sputum in mild COPD subjects after short multi-dosing with PUR118 compared to baseline
Measured: 2 days
Assessment of changes in mucociliary clearance after treatment with PUR118 in mild COPD subjects compared to baseline
Measured: single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmatrix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Bioresearch
- Responsible party
- Sponsor
- Investigators
- Stuart Mair, MD, Principal investigator, Quotient Bioresearch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333904
- Sponsor's protocol ID
- 601-0004
- Status last verified
- Sep 2012
- First submitted
- 7 Apr 2011
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Four-Part Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of PUR118 and Placebo in Normal Healthy Volunteers and Subjects With COPD
- ClinicalTrials.gov ID
- NCT01333904
- Acronym / sponsor ID
- 601-0004
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Pulmatrix Inc.Industry (pharma, biotech, devices)
- Collaborators
- Quotient Bioresearch
- Study start
- Feb 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 12 Apr 2011 (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 establish single and multiple dose safety in healthy subjects and subjects with mild chronic pulmonary obstructive disease (COPD). In addition, the study will evaluate preliminary proof of concept endpoints in COPD subjects such as biomarkers in sputum and mucociliary clearance.
Detailed description
The proposed initial trial in healthy subjects and subjects with mild COPD will establish the tolerability of PUR118 in these subjects over single and short multi-day dosing periods. The study will also provide preliminary data regarding PUR118's potential impact on biomarkers in COPD. Finally, this trial will assess PUR118's effect on mucociliary clearance. This is a four part study enrolling healthy volunteers in a single ascending dose design (SAD; Part I), followed by multiple ascending dose design (MAD; Part II). Contingent on demonstration of safety in a healthy subject population, the study will enroll mild COPD subjects for a short multi-dose design (Part III) incorporating safety and pharmacodynamic endpoints. Lastly Part IV of the trial will assess the effect of PUR118 on mucociliary clearance in mild COPD subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PUR118 | Experimental | Drug: PUR118 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PUR118inhaled | Drug | PUR118 |
Primary outcome
Safety and tolerability assessed by changes in clinical signs and symptoms, clinical safety laboratory tests, vital signs, ECG, spirometry, oxygen saturation, telemetry and adverse events
Time frame: 2 weeks
2 secondary outcomes
Assessment of biomarkers of inflammation and COPD in induced sputum in mild COPD subjects after short multi-dosing with PUR118 compared to baseline
Time frame: 2 days
Assessment of changes in mucociliary clearance after treatment with PUR118 in mild COPD subjects compared to baseline
Time frame: single dose
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 7 Sep 2012.
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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.
Stuart Mair, MD principal investigator
Quotient Bioresearch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PUR118 in people with Chronic Obstructive Pulmonary Disease, run by Pulmatrix Inc. at 1 site 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?
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 7 Sep 2012. 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 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. 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?
Safety and tolerability assessed by changes in clinical signs and symptoms, clinical safety laboratory tests, vital signs, ECG, spirometry, oxygen saturation, telemetry and adverse events (time frame: 2 weeks). 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 7 Sep 2012.