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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01321463




Registration number
NCT01321463
Ethics application status
Date submitted
21/03/2011
Date registered
23/03/2011
Date last updated
11/07/2013

Titles & IDs
Public title
Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) Taking Salmeterol Xinafoate/Fluticasone Propionate Combination
Scientific title
A Phase II, Randomized, Double-Blind, 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 Salmeterol Xinafoate/ Fluticasone Propionate Combination
Secondary ID [1] 0 0
A6631029
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PH-797804
Treatment: Drugs - Placebo

Experimental: PH-797804 -

Placebo Comparator: Placebo -


Treatment: Drugs: PH-797804
6 mg oral tablet once daily for 12 weeks

Treatment: Drugs: Placebo
Placebo oral tablet once daily for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Spirometry measures during 12 weeks of treatment and up to 2 weeks post treatment.
Timepoint [1] 0 0
12 Weeks
Secondary outcome [1] 0 0
Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 12 weeks of treatment and up to 2 weeks post treatment.
Timepoint [1] 0 0
12 Weeks
Secondary outcome [2] 0 0
Dyspnea index scores.
Timepoint [2] 0 0
12 Weeks
Secondary outcome [3] 0 0
Rescue bronchodilator usage.
Timepoint [3] 0 0
12 Weeks
Secondary outcome [4] 0 0
Symptom scores.
Timepoint [4] 0 0
12 Weeks
Secondary outcome [5] 0 0
Global impression of change (patient and clinician).
Timepoint [5] 0 0
12 Weeks
Secondary outcome [6] 0 0
Blood sample for pharmacokinetics.
Timepoint [6] 0 0
12 Weeks
Secondary outcome [7] 0 0
Blood and urine sample for biomarkers and molecular profiling.
Timepoint [7] 0 0
12 Weeks

Eligibility
Key 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 smoking history of at least 10 pack-years and be current smokers
or ex-smokers that gave up > 6 months ago.

- Subjects must be treated with a LABA/ICS combination for at least 1 month prior to
screening.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- A COPD exacerbation requiring treatment with oral steroids or hospitalization for the
treatment of COPD within 3 months of screening.

- History or presence of significant cardiovascular disease.

- ECG abnormalities.

- Significant concomitant clinical disease that could interfere with the conduct, safety
or interpretation of results of this study.

- Evidence of organ or blood disorders.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2012
Sample size
Target
Accrual to date
Final
377
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Daw Park
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
5041 - Daw Park
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
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Ohio
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United States of America
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Rhode Island
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Argentina
State/province [13] 0 0
Buenos Aires
Country [14] 0 0
Argentina
State/province [14] 0 0
Santa Fe
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Ruse
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Sevlievo
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Sofia
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Stara Zagora
Country [19] 0 0
Canada
State/province [19] 0 0
Alberta
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Chile
State/province [22] 0 0
V Region
Country [23] 0 0
Czech Republic
State/province [23] 0 0
Kutna Hora
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Liberec
Country [25] 0 0
Czech Republic
State/province [25] 0 0
Pardubice
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Czech Republic
State/province [26] 0 0
Praha 10- Malesice
Country [27] 0 0
Czech Republic
State/province [27] 0 0
Tabor
Country [28] 0 0
Hungary
State/province [28] 0 0
Budapest
Country [29] 0 0
Hungary
State/province [29] 0 0
Gyula
Country [30] 0 0
Hungary
State/province [30] 0 0
Szeged
Country [31] 0 0
Hungary
State/province [31] 0 0
Szombathely
Country [32] 0 0
India
State/province [32] 0 0
Gujarat
Country [33] 0 0
India
State/province [33] 0 0
Maharashtra
Country [34] 0 0
India
State/province [34] 0 0
Tamil Nadu
Country [35] 0 0
New Zealand
State/province [35] 0 0
Newtown
Country [36] 0 0
New Zealand
State/province [36] 0 0
Tauranga
Country [37] 0 0
Poland
State/province [37] 0 0
Leczna
Country [38] 0 0
Poland
State/province [38] 0 0
Warszawa
Country [39] 0 0
Poland
State/province [39] 0 0
Zawadzkie
Country [40] 0 0
Slovakia
State/province [40] 0 0
Bojnice
Country [41] 0 0
Slovakia
State/province [41] 0 0
Bratislava
Country [42] 0 0
Slovakia
State/province [42] 0 0
Kosice
Country [43] 0 0
Slovakia
State/province [43] 0 0
Liptovsky Hradok
Country [44] 0 0
Slovakia
State/province [44] 0 0
Povazska Bystrica
Country [45] 0 0
Slovakia
State/province [45] 0 0
Spisska Nova Ves
Country [46] 0 0
South Africa
State/province [46] 0 0
Cape Town
Country [47] 0 0
South Africa
State/province [47] 0 0
Durban
Country [48] 0 0
South Africa
State/province [48] 0 0
Kwa-Zulu Natal
Country [49] 0 0
South Africa
State/province [49] 0 0
Bloemfontein
Country [50] 0 0
Sweden
State/province [50] 0 0
Goteborg
Country [51] 0 0
Sweden
State/province [51] 0 0
Lund
Country [52] 0 0
Sweden
State/province [52] 0 0
Stockholm
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Hull
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Glasgow

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
PH-797804 is an oral ant-inflammatory drug that may reduce the inflammation that is
associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential
safety and efficacy profile in COPD.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01321463
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01321463