Trial · NCT00723021
PF-04191834 Single Dose Bronchodilatory Study In Asthma.
NCT00723021, Phase 2, Completed, Pfizer; results first posted 2013-02-01
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. PF-04191834 Single Dose Bronchodilatory Study In Asthma. Trials, record NCT00723021. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00723021
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PF-04191834 Single Dose Bronchodilatory Study In Asthma.
- NCT number
- NCT00723021
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Asthma
- Interventions
- PF-04191834, PF-04191834, PF-04191834, zileuton, Placebo
- First posted
- 2008-07-28
- Last updated
- 2013-02-01
- Results first posted
- 2013-02-01
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Baseline, 12 hours (hrs) post-dose | The FEV1 is the maximal volume of air that can be forcefully exhaled in one second |
| Primary | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Baseline, 24 hours (hrs) post-dose | The FEV1 is the maximal volume of air that can be forcefully exhaled in one second |
| Secondary | Change From Baseline in Forced Vital Capacity (FVC) | Baseline, 12 hours (hrs) post-dose | The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible |
| Secondary | Change From Baseline in Forced Vital Capacity (FVC) | Baseline,24 hours (hrs) post-dose | The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible |
| Secondary | Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75) | Baseline, 12 hours (hrs) post-dose | The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity |
| Secondary | Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75) | Baseline, 24 hours (hrs) post-dose | The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity |
| Other | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) |
| Other | Maximum Observed Plasma Concentration (Cmax) | Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. | |
| Other | Time to Reach Maximum Observed Plasma Concentration (Tmax) | Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. | |
| Other | Plasma Decay Half-Life (t1/2) | Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Baseline, 12 hours (hrs) post-dose | All enrolled participants treated who had at least 1 concentration in at least 1 treatment period | L | MEAN |
| PRIMARY | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Baseline, 24 hours (hrs) post-dose | All enrolled participants treated who had at least 1 concentration in at least 1 treatment period | L | MEAN |
| SECONDARY | Change From Baseline in Forced Vital Capacity (FVC) | Baseline, 12 hours (hrs) post-dose | All enrolled participants treated who had at least 1 concentration in at least 1 treatment period | L | MEAN |
| SECONDARY | Change From Baseline in Forced Vital Capacity (FVC) | Baseline,24 hours (hrs) post-dose | All enrolled participants treated who had at least 1 concentration in at least 1 treatment period | L | MEAN |
| SECONDARY | Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75) | Baseline, 12 hours (hrs) post-dose | All enrolled participants treated who had at least 1 concentration in at least 1 treatment period | L/Sec | MEAN |
| SECONDARY | Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75) | Baseline, 24 hours (hrs) post-dose | All enrolled participants treated who had at least 1 concentration in at least 1 treatment period | L | MEAN |
| OTHER_PRE_SPECIFIED | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. | All enrolled subjects treated who have at least one of the PK parameters of interest in at least one treatment period. | ng*h/mL | MEAN |
| OTHER_PRE_SPECIFIED | Maximum Observed Plasma Concentration (Cmax) | Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. | All enrolled subjects treated who have at least one of the PK parameters of interest in at least one treatment period. | ng/mL | MEAN |
| OTHER_PRE_SPECIFIED | Time to Reach Maximum Observed Plasma Concentration (Tmax) | Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. | hrs | MEDIAN | |
| OTHER_PRE_SPECIFIED | Plasma Decay Half-Life (t1/2) | Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. | Since the PK sample collection only occurred until 24 hours and the approximate t1/2 at all doses appeared to be \>10 hours, t1/2 and area under the plasma concentration versus time curve until infinity (AUCinf) are not reported at any dose level. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group69
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Placebo | Baseline | 2.624 | Standard Deviation 0.3939 | L |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | PF-04191834 30 mg | Baseline | 2.626 | Standard Deviation 0.3860 | L |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | PF-04191834 100 mg | Baseline | 2.585 | Standard Deviation 0.5200 | L |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | PF-04191834 2000 mg | Baseline | 2.579 | Standard Deviation 0.4131 | L |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Zileuton CR 1200 mg | Baseline | 2.609 | Standard Deviation 0.4502 | L |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Placebo | Change at 12 Hours Postdose | 0.064 | Standard Deviation 0.3098 | L |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | PF-04191834 30 mg | Change at 12 Hours Postdose | 0.164 | Standard Deviation 0.1859 | L |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | PF-04191834 100 mg | Change at 12 Hours Postdose | 0.152 | Standard Deviation 0.2072 | L |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | PF-04191834 2000 mg | Change at 12 Hours Postdose | 0.265 | Standard Deviation 0.3047 | L |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Zileuton CR 1200 mg | Change at 12 Hours Postdose | 0.131 | Standard Deviation 0.1566 | L |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 results by groupParticipant flow75
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Intervention Period 1 | STARTED | Treatment Sequence 1 | 3 | |
| Intervention Period 1 | STARTED | Treatment Sequence 2 | 3 | |
| Intervention Period 1 | STARTED | Treatment Sequence 3 | 3 | |
| Intervention Period 1 | STARTED | Treatment Sequence 4 | 3 | |
| Intervention Period 1 | STARTED | Treatment Sequence 5 | 3 | |
| Intervention Period 1 | COMPLETED | Treatment Sequence 1 | 3 | |
| Intervention Period 1 | COMPLETED | Treatment Sequence 2 | 3 | |
| Intervention Period 1 | COMPLETED | Treatment Sequence 3 | 3 | |
| Intervention Period 1 | COMPLETED | Treatment Sequence 4 | 3 | |
| Intervention Period 1 | COMPLETED | Treatment Sequence 5 | 3 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 participant flowAdverse events80
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ventricular extrasystoles | Cardiac disorders | Placebo | 0 | 15 | |
| other | Ventricular extrasystoles | Cardiac disorders | PF-04191834 30 mg | 0 | 14 | |
| other | Ventricular extrasystoles | Cardiac disorders | PF-04191834 100 mg | 1 | 15 | |
| other | Ventricular extrasystoles | Cardiac disorders | PF-04191834 2000 mg | 0 | 15 | |
| other | Ventricular extrasystoles | Cardiac disorders | Zileuton CR 1200 mg | 0 | 15 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 1 | 15 | |
| other | Dry mouth | Gastrointestinal disorders | PF-04191834 30 mg | 0 | 14 | |
| other | Dry mouth | Gastrointestinal disorders | PF-04191834 100 mg | 1 | 15 | |
| other | Dry mouth | Gastrointestinal disorders | PF-04191834 2000 mg | 1 | 15 | |
| other | Dry mouth | Gastrointestinal disorders | Zileuton CR 1200 mg | 1 | 15 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | PF-04191834 30 mg | ||
| Total, all-cause mortality | PF-04191834 100 mg | ||
| Total, all-cause mortality | PF-04191834 2000 mg | ||
| Total, all-cause mortality | Zileuton CR 1200 mg | ||
| Total, other adverse events | Placebo | 9 | 15 |
| Total, other adverse events | PF-04191834 30 mg | 4 | 14 |
| Total, other adverse events | PF-04191834 100 mg | 10 | 15 |
| Total, other adverse events | PF-04191834 2000 mg | 4 | 15 |
| Total, other adverse events | Zileuton CR 1200 mg | 12 | 15 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00723021
GET https://conductscience.org/api/trials/v1/NCT00723021/results?page=2