Chronic Obstructive Pulmonary Disease (COPD)Phase 1NCT01314885
Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers
A Phase 1 study testing PF-03715455 and PH-797804 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Pfizer at 2 sites in United Kingdom.
Trial summary
A single dose study with the inhaled anti-inflammatory agent PF-03715455 to establish if it has anti-inflammatory activity following a challenge with LPS. Inhaled LPS invokes an acute inflammatory response in the lung which can be seen in induced sputum. PH-0797804 is an internal control for the study. 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?
- PF-03715455 and PH-797804
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2011to Dec 2011
- 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
- Male or female (of non-child bearing potential) subjects, aged 18-50 years.
- Subjects whose FEV1 and FVC at screening are both greater than or equal to 80% of their predicted value for age, race, sex and height.
- Subjects who have normoresponsive airways.
- Subjects who are able to successfully complete screening sputum inductions.
Who cannot join
- Subjects who have evidence, on review of pre-study laboratory data and full physical examination, or history of any clinically significant hematological, renal, endocrine, gastrointestinal, dermatological, hepatic, psychiatric, neurologic diseases. Specifically liver function tests and CRP must be within the reference range.
- Subjects with a medical history of asthma symptomatology (ie, wheeze and/or dyspnea at rest).
- Subjects who have experienced a respiratory tract infection within the previous 4 weeks or any other infection within 1 week of dosing
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Pfizer Investigational Site
London, SE1 1YR
Pfizer Investigational Site
Manchester, M23 9QZ
About this study
Official title: Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Way Crossover Study To Determine The Effects Of Single Inhaled Doses Of PF-03715455 (20 Mg) And PH-797804 (30 Mg) On Induced Sputum Neutrophils Following Inhaled Lipopolysaccharide (LPS) Challenge In Healthy Volunteers
A single dose study with the inhaled anti-inflammatory agent PF-03715455 to establish if it has anti-inflammatory activity following a challenge with LPS. Inhaled LPS invokes an acute inflammatory response in the lung which can be seen in induced sputum. PH-0797804 is an internal control for the study.
Read the detailed description
Proof of Mechanism
- Being tested
- PF-03715455, PH-797804, Placebo for PF-03715455, Placebo for PH-797804
- Keywords
- Healthy
- 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.
PF-03715455Drug
20mg, Inhaled, single dose
PH-797804Drug
30mg, Oral, single dose
Placebo for PF-03715455Drug
Single dose, inhaled, Placebo for PF-03715455
Placebo for PH-797804Drug
Single Dose, Oral, Placebo for PH-797804
| Study group | Role | What they receive |
|---|---|---|
| PF-03715455 | Experimental | Not described Receives: Drug: PF-03715455 |
| PH-797804 | Experimental | Not described Receives: Drug: PH-797804 |
| Placebo for PF-03715455 | Placebo comparator | Not described Receives: Drug: Placebo for PF-03715455 |
| Placebo for PH-797804 | Placebo comparator | Not described Receives: Drug: Placebo for PH-797804 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post LPS sputum neutrophil % is being evaluated at the end of each treatment period to establish the effect of treatment on this endpoint
Measured: 6 hours
Secondary outcomes (6)
Cell counts, IL-6, MPO, MCP-1, MIP1b are individual endpoints which will be evaluated in sputum however they are collected as a single sample.
Measured: 6 hours
Post-LPS systemic inflammatory indices: Neutrophil count, IL-6, IL-10, MPO, MCP-1, MIP1b, fibrinogen, CC16 and CRP. These are individual endpoints which will be evaluated in blood however they are collected as a single sample.
Measured: 1, 4, 6 and 7 hours
Number of participants with adverse events
Measured: Baseline, Day 1 and Day 2
Change from baseline in ECG parameters
Measured: Baseline, Day 1 and Day 2
Change from baseline in BP parameters
Measured: Baseline, Day 1 and Day 2
Change from baseline in lab safety parameters
Measured: Baseline, Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionDec 2011
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.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314885
- Sponsor's protocol ID
- A9111003
- Status last verified
- Feb 2012
- First submitted
- 5 Nov 2010
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Way Crossover Study To Determine The Effects Of Single Inhaled Doses Of PF-03715455 (20 Mg) And PH-797804 (30 Mg) On Induced Sputum Neutrophils Following Inhaled Lipopolysaccharide (LPS) Challenge In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01314885
- Acronym / sponsor ID
- A9111003
- Keywords
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Mar 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.
A single dose study with the inhaled anti-inflammatory agent PF-03715455 to establish if it has anti-inflammatory activity following a challenge with LPS. Inhaled LPS invokes an acute inflammatory response in the lung which can be seen in induced sputum. PH-0797804 is an internal control for the study.
Detailed description
Proof of Mechanism
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PF-03715455 | Experimental | Drug: PF-03715455 |
| PH-797804 | Experimental | Drug: PH-797804 |
| Placebo for PF-03715455 | Placebo comparator | Drug: Placebo for PF-03715455 |
| Placebo for PH-797804 | Placebo comparator | Drug: Placebo for PH-797804 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female (of non-child bearing potential) subjects, aged 18-50 years.
- Subjects whose FEV1 and FVC at screening are both greater than or equal to 80% of their predicted value for age, race, sex and height.
- Subjects who have normoresponsive airways.
- Subjects who are able to successfully complete screening sputum inductions.
Key exclusion criteria (3 listed)
- Subjects who have evidence, on review of pre-study laboratory data and full physical examination, or history of any clinically significant hematological, renal, endocrine, gastrointestinal, dermatological, hepatic, psychiatric, neurologic diseases. Specifically liver function tests and CRP must be within the reference range.
- Subjects with a medical history of asthma symptomatology (ie, wheeze and/or dyspnea at rest).
- Subjects who have experienced a respiratory tract infection within the previous 4 weeks or any other infection within 1 week of dosing
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 |
|---|---|---|
| PF-0371545520mg, Inhaled, single dose | Drug | PF-03715455 |
| PH-79780430mg, Oral, single dose | Drug | PH-797804 |
| Placebo for PF-03715455Single dose, inhaled, Placebo for PF-03715455 | Drug | Placebo for PF-03715455 |
| Placebo for PH-797804Single Dose, Oral, Placebo for PH-797804 | Drug | Placebo for PH-797804 |
Primary outcome
Post LPS sputum neutrophil % is being evaluated at the end of each treatment period to establish the effect of treatment on this endpoint
Time frame: 6 hours
6 secondary outcomes
Cell counts, IL-6, MPO, MCP-1, MIP1b are individual endpoints which will be evaluated in sputum however they are collected as a single sample.
Time frame: 6 hours
Post-LPS systemic inflammatory indices: Neutrophil count, IL-6, IL-10, MPO, MCP-1, MIP1b, fibrinogen, CC16 and CRP. These are individual endpoints which will be evaluated in blood however they are collected as a single sample.
Time frame: 1, 4, 6 and 7 hours
Number of participants with adverse events
Time frame: Baseline, Day 1 and Day 2
Change from baseline in ECG parameters
Time frame: Baseline, Day 1 and Day 2
Change from baseline in BP parameters
Time frame: Baseline, Day 1 and Day 2
Change from baseline in lab safety parameters
Time frame: Baseline, Day 1 and Day 2
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 2 Feb 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 PF-03715455 and PH-797804 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Pfizer 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 4 inclusion and 3 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 2 Feb 2012. 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?
Post LPS sputum neutrophil % is being evaluated at the end of each treatment period to establish the effect of treatment on this endpoint (time frame: 6 hours). 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 2 Feb 2012.