AsthmaPhase 1NCT00856687
A Study To Assess The Effect Of PF-03893787 On Lung Function Following An Allergen Challenge In Asthmatic Subjects
A Phase 1 study testing PF-03893787 and Montelukast in people with Asthma, run by Pfizer at 1 site in United Kingdom.
Trial summary
PF-03893787, a novel anti-inflammatory agent should attenuate the effect of a bronchial allergen challenge on lung function and hence provide proof of mechanism for this agent. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- PF-03893787 and Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2009to Dec 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females 18-60 years.
- Mild asthma
- Atopic to allergens
Who cannot join
- Unstable asthma.
- Smokers or recent ex-smokers
- Recent allergen challenge
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Pfizer Investigational Site
Harrow, Middlesex, HA1 3UJ
About this study
Official title: A Randomized, Double-Blind (3rd Party Open), Double-Dummy, Placebo- And Active Controlled, 3-Way Crossover Study To Determine The Effects Of Oral PF-03893787 On Allergen-Induced Airway Responses In Mild Asthmatic Subjects.
PF-03893787, a novel anti-inflammatory agent should attenuate the effect of a bronchial allergen challenge on lung function and hence provide proof of mechanism for this agent.
- Conditions
- Asthma
- Being tested
- PF-03893787, Placebo, Montelukast
- Keywords
- Asthma Allergen Challenge
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-03893787Drug
Oral, two doses 12 hours apart
PlaceboDrug
Oral, two doses 12 hours apart
MontelukastDrug
Oral, two doses 12 hours apart
| Study group | Role | What they receive |
|---|---|---|
| PF-03893787 | Experimental | Not described Receives: Drug: PF-03893787 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Montelukast | Active comparator | Not described Receives: Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirometry pre- and post- bronchial allergen challenge
Measured: 2 months
Secondary outcomes (4)
Laboratory safety tests
Measured: 2 months
12-lead ECGs
Measured: 2 months
Adverse Event reporting
Measured: 2 months
Blood samples for pharmacokinetic measurement
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856687
- Sponsor's protocol ID
- B0281002
- Status last verified
- Jan 2010
- First submitted
- 5 Mar 2009
- Last updated
- 22 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind (3rd Party Open), Double-Dummy, Placebo- And Active Controlled, 3-Way Crossover Study To Determine The Effects Of Oral PF-03893787 On Allergen-Induced Airway Responses In Mild Asthmatic Subjects.
- ClinicalTrials.gov ID
- NCT00856687
- Acronym / sponsor ID
- B0281002
- Conditions
- Asthma
- Keywords
- Asthma Allergen Challenge
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 6 Mar 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.
PF-03893787, a novel anti-inflammatory agent should attenuate the effect of a bronchial allergen challenge on lung function and hence provide proof of mechanism for this agent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PF-03893787 | Experimental | Drug: PF-03893787 |
| Placebo | Placebo comparator | Drug: Placebo |
| Montelukast | Active comparator | Drug: Montelukast |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males and females 18-60 years.
- Mild asthma
- Atopic to allergens
Key exclusion criteria (3 listed)
- Unstable asthma.
- Smokers or recent ex-smokers
- Recent allergen 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 |
|---|---|---|
| PF-03893787Oral, two doses 12 hours apart | Drug | PF-03893787 |
| PlaceboOral, two doses 12 hours apart | Drug | Placebo |
| MontelukastOral, two doses 12 hours apart | Drug | Montelukast |
Primary outcome
Spirometry pre- and post- bronchial allergen challenge
Time frame: 2 months
4 secondary outcomes
Laboratory safety tests
Time frame: 2 months
12-lead ECGs
Time frame: 2 months
Adverse Event reporting
Time frame: 2 months
Blood samples for pharmacokinetic measurement
Time frame: 2 months
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 22 Jan 2010.
- 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
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 PF-03893787 and Montelukast in people with Asthma, run by Pfizer 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 3 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 22 Jan 2010. 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?
Spirometry pre- and post- bronchial allergen challenge (time frame: 2 months). 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 22 Jan 2010.