Chronic Obstructive Pulmonary Disease (COPD)Phase 1NCT01690949
Evaluation of the Effect of PUR118 on Ozone Induced Airway Inflammation in Healthy Normal Volunteers
A Phase 1 study testing PUR118 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Pulmatrix Inc. at 1 site in Germany.
Trial summary
This trial in healthy subjects will assess PUR118's effect on attenuating ozone induced airway inflammation. This trial will establish the tolerability of PUR118 in healthy normal volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- PUR118
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to Apr 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or non pregnant, non lactating healthy females age 18-50 years;
- Must be able to produce acceptable sputum sample by induction;
- Must respond to ozone inhalation with a > 10% increase in the absolute percentage of sputum neutrophils and the total neutrophils (neutrophils/gram sputum) must increase by at least 50% from the sputum neutrophil count at screening;
- Volunteer is a non-smoker or ex-smoker of at least 12 months' duration prior to screening with a history of less than 1 pack per year.
Who cannot join
- Volunteers receiving chronic medication other than oral contraceptives;
- Screening forced expiratory volume FEV1 is < 80% of the predicted value for their age, gender, height and race and/or their FEV1/FVC ration is below 70%;
- Volunteers with significant occupational exposure to respiratory irritants or toxins
- Upper respiratory tract infection within 30 days of the first study day, or lower respiratory tract infection within the last 3 months;
- Volunteers taking any medication that may affect the respiratory tract within 30 days of the first study day;
- Volunteers with a history of asthma
Trial locations and contacts
1 site in 1 country.
Germany1 site
Fraunhofer Institut fur Toxicologie und Experimentelle Medicine (ITEM)
Hanover, 30625
About this study
Official title: Single-blind Evaluation of the Effect of PUR118 on Ozone Induced Airway Inflammation in Healthy Normal Volunteers
This trial in healthy subjects will assess PUR118's effect on attenuating ozone induced airway inflammation. This trial will establish the tolerability of PUR118 in healthy normal volunteers.
- Being tested
- PUR118
- Keywords
- inflammation, COPD, respiratory disease, healthy volunteers
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Inflammation, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUR118Drug
inhaled PUR118, BID
| Study group | Role | What they receive |
|---|---|---|
| PUR118 low dose | Experimental | Not described Receives: Drug: PUR118 |
| PUR118 mid dose | Experimental | Not described Receives: Drug: PUR118 |
| PUR118 high dose | Experimental | Not described Receives: Drug: PUR118 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in sputum cell counts and inflammatory markers
Measured: 6 hours post-initiation of ozone challenge
Change from baseline in white blood cell and inflammatory biomarker counts in blood
Measured: 7 and 24 hours post-initiation of ozone challenge
Secondary outcomes (6)
Change from baseline in pulmonary function
Measured: all post-dose timepoints up to 24 hours post-initiation of ozone challenge
Changes in clinical signs and symptoms from physical examination at baseline
Measured: Subjects will be followed for an expected average of 12 weeks
Changes in clinical safety laboratory tests from baseline
Measured: Subjects will be followed for an expected average of 12 weeks
Changes in vital signs from baseline
Measured: Subjects will be followed for an expected average of 12 weeks
Changes in ECG from baseline
Measured: Subjects will be followed for an expected average of 12 weeks
Number of subjects with adverse events
Measured: Subjects will be followed for an expected average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmatrix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Hanrahan, MD, Study director, Pulmatrix Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690949
- Sponsor's protocol ID
- 601-0005
- Status last verified
- Jul 2013
- First submitted
- 12 Sep 2012
- Last updated
- 19 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Holz O, Biller H, Mueller M, Kane K, Rosano M, Hanrahan J, Hava DL, Hohlfeld JM. Efficacy and safety of inhaled calcium lactate PUR118 in the ozone challenge model--a clinical trial. BMC Pharmacol Toxicol. 2015 Aug 12;16:21. doi: 10.1186/s40360-015-0021-1.
PubMed 26265479
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-blind Evaluation of the Effect of PUR118 on Ozone Induced Airway Inflammation in Healthy Normal Volunteers
- ClinicalTrials.gov ID
- NCT01690949
- Acronym / sponsor ID
- 601-0005
- Keywords
- inflammation, COPD, respiratory disease, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pulmatrix Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 24 Sep 2012 (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.
This trial in healthy subjects will assess PUR118's effect on attenuating ozone induced airway inflammation. This trial will establish the tolerability of PUR118 in healthy normal volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PUR118 low dose | Experimental | Drug: PUR118 |
| PUR118 mid dose | Experimental | Drug: PUR118 |
| PUR118 high dose | Experimental | Drug: PUR118 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males or non pregnant, non lactating healthy females age 18-50 years;
- Must be able to produce acceptable sputum sample by induction;
- Must respond to ozone inhalation with a > 10% increase in the absolute percentage of sputum neutrophils and the total neutrophils (neutrophils/gram sputum) must increase by at least 50% from the sputum neutrophil count at screening;
- Volunteer is a non-smoker or ex-smoker of at least 12 months' duration prior to screening with a history of less than 1 pack per year.
Key exclusion criteria (6 listed)
- Volunteers receiving chronic medication other than oral contraceptives;
- Screening forced expiratory volume FEV1 is < 80% of the predicted value for their age, gender, height and race and/or their FEV1/FVC ration is below 70%;
- Volunteers with significant occupational exposure to respiratory irritants or toxins
- Upper respiratory tract infection within 30 days of the first study day, or lower respiratory tract infection within the last 3 months;
- Volunteers taking any medication that may affect the respiratory tract within 30 days of the first study 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 |
|---|---|---|
| PUR118inhaled PUR118, BID | Drug | PUR118 high dose, PUR118 low dose, PUR118 mid dose |
Primary outcome
Change from baseline in sputum cell counts and inflammatory markers
Time frame: 6 hours post-initiation of ozone challenge
Change from baseline in white blood cell and inflammatory biomarker counts in blood
Time frame: 7 and 24 hours post-initiation of ozone challenge
6 secondary outcomes
Change from baseline in pulmonary function
Time frame: all post-dose timepoints up to 24 hours post-initiation of ozone challenge
Changes in clinical signs and symptoms from physical examination at baseline
Time frame: Subjects will be followed for an expected average of 12 weeks
Changes in clinical safety laboratory tests from baseline
Time frame: Subjects will be followed for an expected average of 12 weeks
Changes in vital signs from baseline
Time frame: Subjects will be followed for an expected average of 12 weeks
Changes in ECG from baseline
Time frame: Subjects will be followed for an expected average of 12 weeks
Number of subjects with adverse events
Time frame: Subjects will be followed for an expected average of 12 weeks
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 19 Jul 2013.
- Derived from this study: PubMed 26265479Holz O, Biller H, Mueller M, Kane K, Rosano M, Hanrahan J, Hava DL, Hohlfeld JM. Efficacy and safety of inhaled calcium lactate PUR118 in the ozone challenge model--a clinical trial. BMC Pharmacol Toxicol. 2015 Aug 12;16:21. doi: 10.1186/s40360-015-0021-1.
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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.
John Hanrahan, MD study director
Pulmatrix Inc.
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 (COPD), run by Pulmatrix Inc. at 1 site in Germany.
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 4 inclusion and 6 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 19 Jul 2013. 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 Germany. 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?
Change from baseline in sputum cell counts and inflammatory markers (time frame: 6 hours post-initiation of ozone challenge). The study lists 2 primary outcomes in all. 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 NCT01690949, 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 19 Jul 2013.