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Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) On A Background Of Tiotropium Bromide

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35205 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Obstructive Pulmonary Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female subjects between, and including, the ages of 40 and 80 years.

- Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD)
and who meet the criteria for Stage II-III disease: Subjects must have a
post-bronchodilator FEV1/FVC ratio (inclusive) of the predicted value for age, height, race and sex using European
Community for Coal and Steel ECCS standards or NHANES III standards.

- Subjects must have a smoking history of at least 10 pack-years* and meet one of the
following criteria: They are current smokers, or they are ex-smokers who have
abstained from smoking for at least 6 months.

- Subjects treated with tiotropium bromide (SPIRIVA HandiHaler) 18 microgram daily for
at least 1 month prior to screening.

- Subjects must have had stable disease for at least 1 month prior to screening. During
the screening and run-in phase subjects must be able to manage disease symptoms
adequately with tiotropium bromide +/- salbutamol (albuterol) rescue medication
(subjects should not use >10 actuations [100 microgram/actuations] daily for more than
2 consecutive days), without reliance on other therapies including oral or inhaled
corticosteroids, other long-acting bronchodilators, nebulizer therapy, theophylline,
roflumilast or regular oxygen.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- A COPD exacerbation requiring treatment with oral steroids or hospitalization for the
treatment of COPD within 3 months of screening.

- History of a lower respiratory tract infection or significant disease instability
during the month preceding screening or during the time between screening and
randomization.

- History or presence of respiratory failure, cor pulmonale or right ventricular
failure.

- Subjects with home oxygen therapy (either PRN or long-term oxygen therapy).

- Any clearly documented history of adult asthma or other chronic respiratory disorders
(eg, bronchiectasis, pulmonary fibrosis, pneumoconiosis).

- Known previous diagnosis of Hepatitis B or C or HIV infection (specific screening is
not required).

- History of cancer (other than cutaneous basal cell) in the previous 5 years.

- Active or past history of GI hemorrhage of any etiology, peptic ulceration, erosive
esophagitis, gastric outlet obstruction or inflammatory bowel disease.

- Regular use of aspirin at a dose greater than 325 mg/day.

- History within the previous 6 months of: myocardial infarction, cardiac arrhythmia
(eg, atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter,
supraventricular tachycardia, ventricular tachycardia), left ventricular failure,
unstable angina, coronary angioplasty, coronary artery bypass grafting (CABG) or
cerebrovascular accident (including transient ischemic attacks).

- A family history of long QT syndrome.

- Presenting with: Any condition possibly affecting oral drug absorption (eg,
gastrectomy or clinically significant diabetic gastroenteropathy).

- Any clinically significant skin lesions as described in Common Terminology Criteria
for Adverse Events for Dermatology (CTCAE) Version 3.0.

- Any clinically significant active systemic or cutaneous infection including herpetic
lesions.

- Congestive heart failure requiring treatment New York Heart Association (NYHA) Class
III-IV.

- ECG abnormalities at screening or randomization, including those listed below:
Subjects with pre-randomization evidence of QTcF prolongation (defined as >450 ms) at
screening or baseline (Week 0) are not eligible for randomization. This assessment is
based on a confirmed mean of the triplicate ECG recordings and is made by the
investigator at the time of ECG collection.

- Predominant heart rhythm other than normal sinus rhythm eg, atrial fibrillation,
atrial flutter, supraventricular tachycardia.

- Atrioventricular (AV) block greater than first degree.

- Resting heart rate >100 or

- Evidence of previous myocardial infarction in the absence of clinical history
consistent with these findings.

- Evidence of acute ischemia.

NCT01543919
Pfizer
Completed
Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) On A Background Of Tiotropium Bromide

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Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) On A Background Of Tiotropium Bromide
A Phase 2B, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Once-Daily Orally Administered PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) On A Background Of Tiotropium Bromide
PH-797804 is an oral anti-inflammatory drug that may reduce the inflammation that is associated with Chronic Obstructive Pulmonary Disease (COPD). PH-797804 will be dosed to patients with Chronic Obstructive Pulmonary Disease (COPD) to evaluate its potential safety and efficacy profile in Chronic Obstructive Pulmonary Disease (COPD)
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: PH-797804
    0.25 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
  • Drug: PH-797804
    1 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
  • Drug: PH-797804
    3 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
  • Drug: PH-797804
    6 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
  • Drug: PH-797804
    10 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
  • Drug: Placebo
    Placebo oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
  • Experimental: PH-787904 (arm1)
    Intervention: Drug: PH-797804
  • Experimental: PH-787904 (arm2)
    Intervention: Drug: PH-797804
  • Experimental: PH-787904 (arm3)
    Intervention: Drug: PH-797804
  • Experimental: PH-787904 (arm4)
    Intervention: Drug: PH-797804
  • Experimental: PH-787904 (arm5)
    Intervention: Drug: PH-797804
  • Experimental: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
730
September 2013
September 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects between, and including, the ages of 40 and 80 years.
  • Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease: Subjects must have a post-bronchodilator FEV1/FVC ratio <0.7 and a post-bronchodilator FEV1 of 30 - 80% (inclusive) of the predicted value for age, height, race and sex using European Community for Coal and Steel ECCS standards or NHANES III standards.
  • Subjects must have a smoking history of at least 10 pack-years* and meet one of the following criteria: They are current smokers, or they are ex-smokers who have abstained from smoking for at least 6 months.
  • Subjects treated with tiotropium bromide (SPIRIVA HandiHaler) 18 microgram daily for at least 1 month prior to screening.
  • Subjects must have had stable disease for at least 1 month prior to screening. During the screening and run-in phase subjects must be able to manage disease symptoms adequately with tiotropium bromide +/- salbutamol (albuterol) rescue medication (subjects should not use >10 actuations [100 microgram/actuations] daily for more than 2 consecutive days), without reliance on other therapies including oral or inhaled corticosteroids, other long-acting bronchodilators, nebulizer therapy, theophylline, roflumilast or regular oxygen.

Exclusion Criteria:

  • A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of screening.
  • History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomization.
  • History or presence of respiratory failure, cor pulmonale or right ventricular failure.
  • Subjects with home oxygen therapy (either PRN or long-term oxygen therapy).
  • Any clearly documented history of adult asthma or other chronic respiratory disorders (eg, bronchiectasis, pulmonary fibrosis, pneumoconiosis).
  • Known previous diagnosis of Hepatitis B or C or HIV infection (specific screening is not required).
  • History of cancer (other than cutaneous basal cell) in the previous 5 years.
  • Active or past history of GI hemorrhage of any etiology, peptic ulceration, erosive esophagitis, gastric outlet obstruction or inflammatory bowel disease.
  • Regular use of aspirin at a dose greater than 325 mg/day.
  • History within the previous 6 months of: myocardial infarction, cardiac arrhythmia (eg, atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), left ventricular failure, unstable angina, coronary angioplasty, coronary artery bypass grafting (CABG) or cerebrovascular accident (including transient ischemic attacks).
  • A family history of long QT syndrome.
  • Presenting with: Any condition possibly affecting oral drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy).
  • Any clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3.0.
  • Any clinically significant active systemic or cutaneous infection including herpetic lesions.
  • Congestive heart failure requiring treatment New York Heart Association (NYHA) Class III-IV.
  • ECG abnormalities at screening or randomization, including those listed below: Subjects with pre-randomization evidence of QTcF prolongation (defined as >450 ms) at screening or baseline (Week 0) are not eligible for randomization. This assessment is based on a confirmed mean of the triplicate ECG recordings and is made by the investigator at the time of ECG collection.
  • Predominant heart rhythm other than normal sinus rhythm eg, atrial fibrillation, atrial flutter, supraventricular tachycardia.
  • Atrioventricular (AV) block greater than first degree.
  • Resting heart rate >100 or <40 bpm.
  • Evidence of previous myocardial infarction in the absence of clinical history consistent with these findings.
  • Evidence of acute ischemia.
Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Bulgaria,   Canada,   Czech Republic,   Germany,   Hungary,   Japan,   Poland,   Slovakia,   South Africa,   Spain,   Sweden,   Taiwan,   United States
 
 
NCT01543919
A6631033
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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