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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
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
Country [26] 0 0
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/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
Other publications