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| ID | Type | Description | Link |
|---|---|---|---|
| INHALED P38I ASTHMA | Other Identifier | Alias Study Number |
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The termination was due to business reasons. No safety or efficacy concerns contributed to the termination of the study
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The study proposes to evaluate the safety and efficacy of PF-03715455 in moderate to severe asthma when added to standard of care and during staged withdrawal of background therapy.
Study terminated on 7th April 2015. The termination was due to business reasons. No safety or efficacy concerns contributed to the termination of the study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matched blinded placebo |
|
| PF-03715455 | Experimental | PF-03715455 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 680 micrograms BID, Orally inhaled placebo for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Asthma Worsening Events | Asthma worsening was defined as one of the following events: greater than or equal to (>=) 30% reduction from baseline in morning peak expiratory flow (PEF) on 2 consecutive days; >=6 additional rescue puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; deterioration of asthma (as determined by the Investigator) requiring systemic steroid treatment, an increase in inhaled corticosteroids >=4 times the last dose received prior to discontinuation from the study, or hospitalization due to asthma. | Baseline up to follow-up period (Week 16) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Asthma Worsening Event | The time post randomization that the first asthma worsening event occurred (defined above). | Baseline up to follow-up period (Week 16) |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center of Alabama | Birmingham | Alabama | 35209 | United States | ||
| Pulmonary Associates, Pa |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Twice Daily | Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler. |
| FG001 | PF-03715455 680 mcg Twice Daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| PF-03715455 |
| Drug |
680 micrograms BID, Orally inhaled PF-03715455 for 12 weeks |
|
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Baseline was defined as the latest measurement before first dosing.
| Baseline, Week 1, Week 2, Week 3, and Week 4 |
| Change From Baseline in Forced Vital Capacity (FVC) | FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. | Baseline, Week 1, Week 2, Week 3, and Week 4 |
| Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6) | FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. | Baseline, Week 1, Week 2, Week 3, and Week 4 |
| Change From Baseline in Asthma Symptom Scores | Participants used a daily diary assessment to record overall asthma symptom scores twice a day (morning and evening). Questions included extent of albuterol use, symptoms of wheezing, breathlessness, chest tightness, and cough. The visit dependent asthma symptom scores were calculated based on the item in the daily diary assessment. A participant summarized her/his daily frequency of asthma symptoms during the last 24 hours by the assignment of an integer score (0,1,2,3 or 4). The score=0 value denoted the day without symptoms and the score=4 value denoted the day where symptoms occurred all of the time. The asthma symptom scores were calculated by averaging the values of the daily scores within visit-dependent time window. Higher score indicates asthma worsening | Baseline, Week 1, Week 2, Week 3, and Week 4 |
| Number of Night Time Awakenings Per Week | The number of nocturnal awakenings due to asthma symptoms was recorded by the participant. | Baseline, Week 1, Week 2, Week 3, and Week 4 |
| Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. The changes from baseline (CFB) at each week and over 4 weeks were analyzed. | Baseline, Week 1, Week 2, Week 3, and Week 4 |
| Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4 | The 5-question version of the Juniper ACQ is a validated questionnaire to evaluate asthma control. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score was the mean of the responses. Mean scores of <= 0.75 indicate well-controlled asthma, scores between 0.76 and less than (<) 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. | Baseline, Week 1, Week 2, Week 3, and Week 4 |
| Number of Daily Puffs of Rescue Medication | The use of rescue bronchodilators (albuterol or levalbuterol) for symptomatic relief of asthma in a 24-hour period was recorded by the participant. | Baseline, Week 1, Week 2, Week 3, and Week 4 |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Little Rock Allergy & Asthma Clinical Research Center | Little Rock | Arkansas | 72205-4565 | United States |
| California Research Medical Group, Inc | Fullerton | California | 92835 | United States |
| California Allergy and Asthma Medical Group, Inc. | Los Angeles | California | 90025 | United States |
| Jonathan Corren MD, Inc. | Los Angeles | California | 90025 | United States |
| Integrated Research Group, Incorporated | Riverside | California | 92506 | United States |
| Peninsula Research Associates | Rolling Hills Estates | California | 90274 | United States |
| Allergy Associates Medical Group | San Diego | California | 92108 | United States |
| Asthma and Allergy Associates, PC | Colorado Springs | Colorado | 80907 | United States |
| Colorado Allergy and Asthma Centers, PC | Denver | Colorado | 80230 | United States |
| University of South Florida - Asthma, Allergy and Immunology Clinical Research Unit | Tampa | Florida | 33613 | United States |
| Florida Pulmonary Research Institute, LLC | Winter Park | Florida | 32789 | United States |
| Chesapeake Clinical Research, Inc. | Baltimore | Maryland | 21236 | United States |
| Northeast Medical Research Associates, Inc. | North Dartmouth | Massachusetts | 02747 | United States |
| Clinical Research Institute | Minneapolis | Minnesota | 55402 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Associated Specialists in Medicine, PC | St Louis | Missouri | 63141 | United States |
| The Clinical Research Center, L.L.C. | St Louis | Missouri | 63141 | United States |
| The Asthma and Allergy Center | Bellevue | Nebraska | 68123 | United States |
| North Shore Long Island Jewish Health System | New Hyde Park | New York | 11040 | United States |
| American Health Research | Charlotte | North Carolina | 28277 | United States |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27103 | United States |
| Bernstein Clinical Research Center | Cincinnati | Ohio | 45231 | United States |
| University of Pittsburgh Asthma Institute | Pittsburgh | Pennsylvania | 15213 | United States |
| Upstate Pharmaceutical Research | Greenville | South Carolina | 29615 | United States |
| The Allergy & Asthma Clinic of Central Texas | Killeen | Texas | 76542 | United States |
| University of Wisconsin School of Medicine & Public Health | Madison | Wisconsin | 53792 | United States |
Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
| COMPLETED |
|
| NOT COMPLETED |
|
|
The baseline analysis population included all randomized participants who received at least 1 dose of PF-03715455 or placebo.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Twice Daily | Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler. |
| BG001 | PF-03715455 680 mcg Twice Daily | Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Asthma Worsening Events | Asthma worsening was defined as one of the following events: greater than or equal to (>=) 30% reduction from baseline in morning peak expiratory flow (PEF) on 2 consecutive days; >=6 additional rescue puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; deterioration of asthma (as determined by the Investigator) requiring systemic steroid treatment, an increase in inhaled corticosteroids >=4 times the last dose received prior to discontinuation from the study, or hospitalization due to asthma. | The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo. | Posted | Number | percentage of participants | Baseline up to follow-up period (Week 16) |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Asthma Worsening Event | The time post randomization that the first asthma worsening event occurred (defined above). | The modified intent-to-treat (mITT) analysis set initially included all randomized participants who received at least 1 dose of PF-03715455 or placebo. Only 7 participants (4 in PF-03715455 and 3 in placebo) were included in the presented descriptive analysis, since other observations were censored by study termination. | Posted | Median | Full Range | days | Baseline up to follow-up period (Week 16) |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Baseline was defined as the latest measurement before first dosing. | The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category. | Posted | Mean | Standard Deviation | liters | Baseline, Week 1, Week 2, Week 3, and Week 4 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Forced Vital Capacity (FVC) | FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. | The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category. | Posted | Mean | Standard Deviation | liters | Baseline, Week 1, Week 2, Week 3, and Week 4 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6) | FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. | The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category. | Posted | Mean | Standard Deviation | liters | Baseline, Week 1, Week 2, Week 3, and Week 4 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Asthma Symptom Scores | Participants used a daily diary assessment to record overall asthma symptom scores twice a day (morning and evening). Questions included extent of albuterol use, symptoms of wheezing, breathlessness, chest tightness, and cough. The visit dependent asthma symptom scores were calculated based on the item in the daily diary assessment. A participant summarized her/his daily frequency of asthma symptoms during the last 24 hours by the assignment of an integer score (0,1,2,3 or 4). The score=0 value denoted the day without symptoms and the score=4 value denoted the day where symptoms occurred all of the time. The asthma symptom scores were calculated by averaging the values of the daily scores within visit-dependent time window. Higher score indicates asthma worsening | The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 1, Week 2, Week 3, and Week 4 |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Night Time Awakenings Per Week | The number of nocturnal awakenings due to asthma symptoms was recorded by the participant. | The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category. | Posted | Mean | Standard Deviation | night awakenings per week | Baseline, Week 1, Week 2, Week 3, and Week 4 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. The changes from baseline (CFB) at each week and over 4 weeks were analyzed. | The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category. | Posted | Mean | Standard Deviation | liters per minute | Baseline, Week 1, Week 2, Week 3, and Week 4 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4 | The 5-question version of the Juniper ACQ is a validated questionnaire to evaluate asthma control. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score was the mean of the responses. Mean scores of <= 0.75 indicate well-controlled asthma, scores between 0.76 and less than (<) 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. | The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 1, Week 2, Week 3, and Week 4 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Daily Puffs of Rescue Medication | The use of rescue bronchodilators (albuterol or levalbuterol) for symptomatic relief of asthma in a 24-hour period was recorded by the participant. | The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category. | Posted | Mean | Standard Deviation | puffs per day | Baseline, Week 1, Week 2, Week 3, and Week 4 |
|
|
Baseline up to 1 month after end-of-treatment visit (Week 12)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Twice Daily | Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler. | 0 | 26 | 10 | 26 | ||
| EG001 | PF-03715455 680 mcg Twice Daily | Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler. | 0 | 25 | 15 | 25 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Gingival hypertrophy | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Influenza-like illness | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Mouth injury | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA 18.0 | Non-systematic Assessment |
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| Forced expiratory volume decreased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Middle insomnia | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Nasal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Pharyngeal mass | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
The study was terminated early due to portfolio prioritization. Most participants observations of time to asthma worsening event were censored by the study termination.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C569762 | N-(1-(3-chloro-4-hydroxyphenyl)-3-(1,1-dimethylethyl)-1H-pyrazol-5-yl)-N'-((2-((3-(2-((2-hydroxyethyl)thio)phenyl)-1,2,4-triazolo(4,3-a)pyridin-6-yl)thio)phenyl)methyl)-urea |
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| Male |
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