AsthmaPhase 2NCT00723021

PF-04191834 Single Dose Bronchodilatory Study In Asthma.

A Phase 2 study testing PF-04191834 and zileuton in people with Asthma, run by Pfizer at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in patients with asthma 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-04191834 and zileuton
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 4 sitesUnited States
Study dates: Jul 2008to Jul 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Persistent mild/moderate asthma for at least 6 months.
Reduced lung function
Reversible airway obstruction

Who cannot join

Pregnant/nursing females.
Liver function tests greater than upper limit of normal (ULN)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Pfizer Investigational Site
Baltimore, Maryland, 21225
Pfizer Investigational Site
Kalamazoo, Michigan, 49007
Pfizer Investigational Site
North Dartmouth, Massachusetts, 02747
Pfizer Investigational Site
Omaha, Nebraska, 68131

Other trials in United States

About this study

Official title: A Phase 2a, Randomised, Double-Blind (3rd Party Open), Double-Dummy, Placebo And Active Controlled 5-Way Crossover Study To Assess The Bronchodilatory Action, Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-04191834 In Asthmatic Patients.

Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in patients with asthma

Conditions: Asthma
Being tested: PF-04191834, zileuton, Placebo
Keywords: Bronchodilator
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-04191834Drug
30mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets.
PF-04191834Drug
100mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets, single dose.
PF-04191834Drug
2000mg PF-04191834, single dose, oral dispersion + 2 x placebo tables, single dose
zileutonDrug
1200mg, 2 x 600mg tablets, single dose + placebo oral dispersion, single dose.
PlaceboDrug
2 x placebo tablets + placebo oral dispersion, single dose.

Study groups in NCT00723021
Study group	Role	What they receive
PF-04191834 30mg	Experimental	Not described Receives: Drug: PF-04191834
PF-04191834 100mg	Experimental	Not described Receives: Drug: PF-04191834
PF-04191834 2000mg	Experimental	Not described Receives: Drug: PF-04191834
zileuton	Active comparator	Not described Receives: Drug: zileuton
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.

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
The FEV1 is the maximal volume of air that can be forcefully exhaled in one second
Measured: Baseline, 12 hours (hrs) post-dose
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
The FEV1 is the maximal volume of air that can be forcefully exhaled in one second
Measured: Baseline, 24 hours (hrs) post-dose

Secondary outcomes (4)

Change From Baseline in Forced Vital Capacity (FVC)
The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible
Measured: Baseline, 12 hours (hrs) post-dose
Change From Baseline in Forced Vital Capacity (FVC)
The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible
Measured: Baseline,24 hours (hrs) post-dose
Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)
The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity
Measured: Baseline, 12 hours (hrs) post-dose
Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)
The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity
Measured: Baseline, 24 hours (hrs) post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Jul 2009

First posted28 Jul 2008 (estimated)
Study startJul 2008
Primary completionDec 2008
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00723021
Sponsor's protocol ID: B0041002
Status last verified: Dec 2012
First submitted: 24 Jul 2008
Last updated: 1 Feb 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)
Severe Asthma
Active, not recruiting
Nasal Immune Challenge Study
Innate Inflammatory Response, Asthma
Not yet recruiting
Reducing Exposure With Air Cleaners and Technology
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
Not yet recruiting
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Pediatric Asthma, Acute Asthma
Recruiting
Lung Immune Challenge Study: Controlled Exposure to Inhaled Resiquimod (R848)
Innate Immunity, Mucosal Immunity

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a, Randomised, Double-Blind (3rd Party Open), Double-Dummy, Placebo And Active Controlled 5-Way Crossover Study To Assess The Bronchodilatory Action, Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-04191834 In Asthmatic Patients.
ClinicalTrials.gov ID: NCT00723021
Acronym / sponsor ID: B0041002
Conditions: Asthma
Keywords: Bronchodilator
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Dec 2008 (actual)
Study completion: Jul 2009 (actual)
First posted: 28 Jul 2008 (estimated)
Results: Posted 1 Feb 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in patients with asthma

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
PF-04191834 30mg	Experimental	Drug: PF-04191834
PF-04191834 100mg	Experimental	Drug: PF-04191834
PF-04191834 2000mg	Experimental	Drug: PF-04191834
zileuton	Active comparator	Drug: zileuton
placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Persistent mild/moderate asthma for at least 6 months.
Reduced lung function
Reversible airway obstruction

Key exclusion criteria (2 listed)

Pregnant/nursing females.
Liver function tests greater than upper limit of normal (ULN)

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-0419183430mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets.	Drug	PF-04191834 30mg
PF-04191834100mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets, single dose.	Drug	PF-04191834 100mg
PF-041918342000mg PF-04191834, single dose, oral dispersion + 2 x placebo tables, single dose	Drug	PF-04191834 2000mg
zileuton1200mg, 2 x 600mg tablets, single dose + placebo oral dispersion, single dose.	Drug	zileuton
Placebo2 x placebo tablets + placebo oral dispersion, single dose.	Drug	placebo

Primary outcome

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline, 12 hours (hrs) post-dose
The FEV1 is the maximal volume of air that can be forcefully exhaled in one second
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline, 24 hours (hrs) post-dose
The FEV1 is the maximal volume of air that can be forcefully exhaled in one second

4 secondary outcomes

Change From Baseline in Forced Vital Capacity (FVC)
Time frame: Baseline, 12 hours (hrs) post-dose
Change From Baseline in Forced Vital Capacity (FVC)
Time frame: Baseline,24 hours (hrs) post-dose
Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)
Time frame: Baseline, 12 hours (hrs) post-dose
Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)
Time frame: Baseline, 24 hours (hrs) post-dose

Results and safety

Results posted to the registry on 1 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence 1	3	3
Treatment Sequence 2	3	3
Treatment Sequence 3	3	3
Treatment Sequence 4	3	3
Treatment Sequence 5	3	3

Primary outcome: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)

Time frame: Baseline, 12 hours (hrs) post-dose. Mean (Standard Deviation). Unit: L

Measure	Placebo n = 15	PF-04191834 30 mg n = 14	PF-04191834 100 mg n = 15	PF-04191834 2000 mg n = 15	Zileuton CR 1200 mg n = 15
Baseline	2.624 (0.3939)	2.626 (0.3860)	2.585 (0.5200)	2.579 (0.4131)	2.609 (0.4502)
Change at 12 Hours Postdose	0.064 (0.3098)	0.164 (0.1859)	0.152 (0.2072)	0.265 (0.3047)	0.131 (0.1566)

Population analysed: All enrolled participants treated who had at least 1 concentration in at least 1 treatment period

Primary outcome: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)

Time frame: Baseline, 24 hours (hrs) post-dose. Mean (Standard Deviation). Unit: L

Measure	Placebo n = 15	PF-04191834 30 mg n = 14	PF-04191834 100 mg n = 15	PF-04191834 2000 mg n = 15	Zileuton CR 1200 mg n = 15
Baseline	2.624 (0.3939)	2.626 (0.3860)	2.585 (0.5200)	2.579 (0.4131)	2.609 (0.4502)
Change at 24 Hours Postdose	0.122 (0.2553)	0.014 (0.2318)	0.103 (0.2616)	0.162 (0.1559)	0.151 (0.1338)

Population analysed: All enrolled participants treated who had at least 1 concentration in at least 1 treatment period

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 15 (0%)	9 of 15 (60%)	Not reported
PF-04191834 30 mg	0 of 14 (0%)	4 of 14 (28.6%)	Not reported
PF-04191834 100 mg	0 of 15 (0%)	10 of 15 (66.7%)	Not reported
PF-04191834 2000 mg	0 of 15 (0%)	4 of 15 (26.7%)	Not reported
Zileuton CR 1200 mg	0 of 15 (0%)	12 of 15 (80%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Asthma

RecruitingPhase 3
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)
Severe Asthma
Active, not recruiting
Nasal Immune Challenge Study
Innate Inflammatory Response, Asthma
Not yet recruiting
Reducing Exposure With Air Cleaners and Technology
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
Not yet recruiting
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Pediatric Asthma, Acute Asthma
Recruiting
Lung Immune Challenge Study: Controlled Exposure to Inhaled Resiquimod (R848)
Innate Immunity, Mucosal Immunity

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

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-04191834 and zileuton in people with Asthma, run by Pfizer at 4 sites in United States.

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 2 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 1 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Forced Expiratory Volume in 1 Second (FEV1) (time frame: Baseline, 12 hours (hrs) post-dose). 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 NCT00723021.

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 1 Feb 2013.