HealthyPhase 1NCT00947687
Safety and Efficacy Study of Inhaled PUR003 on a Controlled Influenza Virus Challenge in Healthy Adult Subjects
A Phase 1 study testing PUR003 in people with Healthy, run by Pulmatrix Inc. at 1 site in United Kingdom.
Trial summary
The objectives of the study are to demonstrate the effectiveness, safety and tolerability of multiple daily doses of inhaled PUR003, in comparison with placebo, in healthy adults experimentally inoculated with Influenza A/Wisconsin/67/2005 (H3N2) virus. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PUR003
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2009to Oct 2009
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects aged 18 to 45 years.
- In general good health determined by a screening evaluation ≤120 days prior to double-blind IMP administration and on the day of admittance to quarantine.
- Seronegative (NDA) for challenge virus.
- Have not been vaccinated for influenza virus since 2006 (as determined in the medical history) or had a known influenza infection in the current season, defined as in the last 12 months.
Who cannot join
- Presence or evidence of significant acute or chronic, uncontrolled medical or psychiatric illness.
- Abnormal pulmonary function as evidenced by clinically significant abnormality in spirometry.
- Health care workers (including doctors, nurses, medical students and allied healthcare professionals) anticipated to have patient contact within two weeks of discharge from quarantine.
- Intending to travel (to countries for which vaccinations are recommended or where high risk of infections exists).
- Presence of household member or close contact (until 14 days after discharge from quarantine) who is: less than 3 years of age; has any known immunodeficiency; is receiving immunosuppressant medications; is undergoing or soon to undergo cancer chemotherapy within 28 days of challenge.
- Subjects with diagnosed emphysema or chronic obstructive pulmonary disease (COPD); elderly residing in a nursing home, affected by severe lung disease or medical condition; or a transplant (bone marrow or solid organ) organ recipient
Show all 10Show fewer
- Subjects with any history of asthma, COPD, pulmonary hypertension, reactive airway disease, or any chronic lung condition of any aetiology.
- Regular daily smokers during the 6 months prior to study entry or those who have a significant history of any tobacco use at any time (≥ total 10 pack year history = one pack a day for 10 years).
- Presence of any febrile illness or symptoms of upper or lower tract respiratory infection in the 28 days prior to viral inoculation (such subjects may be re-evaluated for enrolment after resolution of the illness).
- Receipt of any investigational drug within 3 months, or prior participation in a clinical trial of any influenza vaccine or medication within 1 year of participation.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guys Drug Research Unit (GDRU), Quintiles Ltd
London, SE1 1YR
About this study
Official title: A Randomized, Phase 1B, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Inhaled PUR003 on a Controlled Influenza Virus Challenge in Healthy Adult Subjects
The objectives of the study are to demonstrate the effectiveness, safety and tolerability of multiple daily doses of inhaled PUR003, in comparison with placebo, in healthy adults experimentally inoculated with Influenza A/Wisconsin/67/2005 (H3N2) virus.
- Conditions
- Healthy
- Being tested
- PUR003, Placebo
- Keywords
- influenza, healthy subject, virus inoculation, symptom scores, viral shedding, bioaerosol output
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUR003Drug
Twice-daily (BID) doses of PUR003 will be delivered via inhalation using a commercially available nebulizer for a total of 7 days
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| PUR003 | Experimental | Not described Receives: Drug: PUR003 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of PUR003 as determined by incidence of adverse events (AEs); changes in physical examination, chest examination; pulmonary function; vital signs; electrocardiogram (ECG) and clinical laboratory assessments.
Measured: Day 6
Secondary outcomes (3)
Subjected-reported symptom scores assessed both individually and as a composite score evaluating severity overall and at the time of peak symptom score
Measured: Day 6 of study
Quantitative viral shedding from nasal viral inoculation until day 6
Measured: Day 0 to day 6
Change in bioaerosol output with treatment and after viral inoculation
Measured: Day -2 to day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionSep 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmatrix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Retroscreen Virology Ltd., Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- John P Hanrahan, MD, Study director, Pulmatrix Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947687
- Sponsor's protocol ID
- 601-0001P-00
- Status last verified
- Sep 2017
- First submitted
- 24 Jul 2009
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase 1B, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Inhaled PUR003 on a Controlled Influenza Virus Challenge in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00947687
- Acronym / sponsor ID
- 601-0001P-00
- Conditions
- Healthy
- Keywords
- influenza, healthy subject, virus inoculation, symptom scores, viral shedding, bioaerosol output
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pulmatrix Inc.Industry (pharma, biotech, devices)
- Collaborators
- Retroscreen Virology Ltd., Quintiles, Inc.
- Study start
- Jul 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 28 Jul 2009 (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 objectives of the study are to demonstrate the effectiveness, safety and tolerability of multiple daily doses of inhaled PUR003, in comparison with placebo, in healthy adults experimentally inoculated with Influenza A/Wisconsin/67/2005 (H3N2) virus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PUR003 | Experimental | Drug: PUR003 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female subjects aged 18 to 45 years.
- In general good health determined by a screening evaluation ≤120 days prior to double-blind IMP administration and on the day of admittance to quarantine.
- Seronegative (NDA) for challenge virus.
- Have not been vaccinated for influenza virus since 2006 (as determined in the medical history) or had a known influenza infection in the current season, defined as in the last 12 months.
Key exclusion criteria (10 listed)
- Presence or evidence of significant acute or chronic, uncontrolled medical or psychiatric illness.
- Abnormal pulmonary function as evidenced by clinically significant abnormality in spirometry.
- Health care workers (including doctors, nurses, medical students and allied healthcare professionals) anticipated to have patient contact within two weeks of discharge from quarantine.
- Intending to travel (to countries for which vaccinations are recommended or where high risk of infections exists).
- Presence of household member or close contact (until 14 days after discharge from quarantine) who is: less than 3 years of age; has any known immunodeficiency; is receiving immunosuppressant medications; is undergoing or soon to undergo cancer chemotherapy within 28 days of challenge.
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 |
|---|---|---|
| PUR003Twice-daily (BID) doses of PUR003 will be delivered via inhalation using a commercially available nebulizer for a total of 7 days | Drug | PUR003 |
| Placebo | Drug | Placebo |
Primary outcome
Safety and tolerability of PUR003 as determined by incidence of adverse events (AEs); changes in physical examination, chest examination; pulmonary function; vital signs; electrocardiogram (ECG) and clinical laboratory assessments.
Time frame: Day 6
3 secondary outcomes
Subjected-reported symptom scores assessed both individually and as a composite score evaluating severity overall and at the time of peak symptom score
Time frame: Day 6 of study
Quantitative viral shedding from nasal viral inoculation until day 6
Time frame: Day 0 to day 6
Change in bioaerosol output with treatment and after viral inoculation
Time frame: Day -2 to day 6
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 Sep 2017.
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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 P 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 PUR003 in people with Healthy, 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?
The sponsor lists 4 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 19 Sep 2017. 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. 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?
Safety and tolerability of PUR003 as determined by incidence of adverse events (AEs); changes in physical examination, chest examination; pulmonary function; vital signs; electrocardiogram (ECG) and clinical laboratory assessments. (time frame: Day 6). 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 19 Sep 2017.