Pulmonary Disease, Chronic ObstructivePhase 2NCT01321463
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
A Phase 2 study testing PH-797804 in people with Pulmonary Disease, Chronic Obstructive, run by Pfizer at 74 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- PH-797804
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 377 participants
- Where
- 74 sitesin 15 countries
- Study dates
- May 2011to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
74 sites in 15 countries.
74 sites in 15 countries
United States22 sites
Pfizer Investigational Site
Cincinnati, Ohio, 45231
Pfizer Investigational Site
Cincinnati, Ohio, 45245
Pfizer Investigational Site
Clearwater, Florida, 33756
Pfizer Investigational Site
Conyers, Georgia, 30094
Pfizer Investigational Site
Duluth, Georgia, 30096
Pfizer Investigational Site
Fridley, Minnesota, 55432
Pfizer Investigational Site
Glendale, Arizona, 85306
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Lincoln, Rhode Island, 02865
Pfizer Investigational Site
Livonia, Michigan, 48152
Pfizer Investigational Site
McKinney, Texas, 75069
Pfizer Investigational Site
Minneapolis, Minnesota, 55407
Pfizer Investigational Site
Mobile, Alabama, 36608
Pfizer Investigational Site
Norcross, Georgia, 30071
Pfizer Investigational Site
Pensacola, Florida, 32504
Pfizer Investigational Site
Rochester, Minnesota, 55905
Pfizer Investigational Site
San Diego, California, 92120
Pfizer Investigational Site
Spartanburg, South Carolina, 29303
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Tampa, Florida, 33603
Pfizer Investigational Site
Tampa, Florida, 33613
Pfizer Investigational Site
Trinity, Florida, 34655
Canada6 sites
Pfizer Investigational Site
Calgary, Alberta, T1Y 6J4
Pfizer Investigational Site
Niagara Falls, Ontario, L2G 1J4
Pfizer Investigational Site
Ottawa, Ontario, K1Y 4G2
Pfizer Investigational Site
Québec, Quebec, G1V 4G5
Pfizer Investigational Site
Toronto, Ontario, M6H 3M2
Pfizer Investigational Site
Trois-Rivières, Quebec, G8T 7A1
Slovakia6 sites
Pfizer Investigational Site
Bojnice, 972 01
Pfizer Investigational Site
Bratislava, 826 06
Pfizer Investigational Site
Košice, 040 01
Pfizer Investigational Site
Liptovský Hrádok, 033 01
Pfizer Investigational Site
Považská Bystrica, 017 26
Pfizer Investigational Site
Spišská Nová Ves, 052 01
Bulgaria5 sites
Pfizer Investigational Site
Rousse, 7002
Pfizer Investigational Site
Sevlievo, 5400
Pfizer Investigational Site
Sofia, 1407
Pfizer Investigational Site
Sofia, 1431
Pfizer Investigational Site
Stara Zagora, 6003
Czechia5 sites
Pfizer Investigational Site
Kutná Hora, 284 01
Pfizer Investigational Site
Liberec, 460 01
Pfizer Investigational Site
Pardubice, 530 09
Pfizer Investigational Site
Praha 10- Malesice, 108 00
Pfizer Investigational Site
Tábor, 39001
South Africa5 sites
Pfizer Investigational Site
Bellville, Cape Town, 7530
Pfizer Investigational Site
Bloemfontein, 9301
Pfizer Investigational Site
Durban, KwaZulu-Natal, 4001
Pfizer Investigational Site
eManzimtoti, Durban, 4126
Pfizer Investigational Site
Tygerberg Campus, Cape Town, 7505
Hungary4 sites
Pfizer Investigational Site
Budapest, 1125
Pfizer Investigational Site
Gyula, 5703
Pfizer Investigational Site
Szeged, 6722
Pfizer Investigational Site
Szombathely, 9700
Sweden4 sites
Pfizer Investigational Site
Gothenburg, 400 14
Pfizer Investigational Site
Gothenburg, 413 45
Pfizer Investigational Site
Lund, 22185
Pfizer Investigational Site
Stockholm, 171 76
Argentina3 sites
Pfizer Investigational Site
Buenos Aires, 1426
Pfizer Investigational Site
Capital Federal, Buenos Aires, C1440BRR
Pfizer Investigational Site
Rosario, Santa Fe Province, 2000
India3 sites
Pfizer Investigational Site
Ahmedabad, Gujarat, 380 052
Pfizer Investigational Site
Coimbatore, Tamil Nadu, 641 004
Pfizer Investigational Site
Nagpur, Maharashtra, 440 012
Poland3 sites
Pfizer Investigational Site
Łęczna, 21-010
Pfizer Investigational Site
Warsaw, 04-141
Pfizer Investigational Site
Zawadzkie, 47-120
Australia2 sites
Pfizer Investigational Site
Daw Park, South Australia, 5041
Pfizer Investigational Site
Nedlands, Western Australia, 6009
Chile2 sites
Pfizer Investigational Site
Quillota, Valparaiso, 2260494
Pfizer Investigational Site
Valparaíso, Valparaiso, 2352499
New Zealand2 sites
Pfizer Investigational Site
Newtown, 6021
Pfizer Investigational Site
Tauranga, 3110
United Kingdom2 sites
Pfizer Investigational Site
Cottingham, Hull, HU16 5JQ
Pfizer Investigational Site
Glasgow, G12 OYN
About this study
Official 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
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- PH-797804, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PH-797804Drug
6 mg oral tablet once daily for 12 weeks
PlaceboDrug
Placebo oral tablet once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| PH-797804 | Experimental | Not described Receives: Drug: PH-797804 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirometry measures during 12 weeks of treatment and up to 2 weeks post treatment.
Measured: 12 Weeks
Secondary outcomes (7)
Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 12 weeks of treatment and up to 2 weeks post treatment.
Measured: 12 Weeks
Dyspnea index scores.
Measured: 12 Weeks
Rescue bronchodilator usage.
Measured: 12 Weeks
Symptom scores.
Measured: 12 Weeks
Global impression of change (patient and clinician).
Measured: 12 Weeks
Blood sample for pharmacokinetics.
Measured: 12 Weeks
Blood and urine sample for biomarkers and molecular profiling.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321463
- Sponsor's protocol ID
- A6631029
- Status last verified
- Jul 2012
- First submitted
- 21 Mar 2011
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01321463
- Acronym / sponsor ID
- A6631029
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PH-797804 | Experimental | Drug: PH-797804 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PH-7978046 mg oral tablet once daily for 12 weeks | Drug | PH-797804 |
| PlaceboPlacebo oral tablet once daily for 12 weeks | Drug | Placebo |
Primary outcome
Spirometry measures during 12 weeks of treatment and up to 2 weeks post treatment.
Time frame: 12 Weeks
7 secondary outcomes
Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 12 weeks of treatment and up to 2 weeks post treatment.
Time frame: 12 Weeks
Dyspnea index scores.
Time frame: 12 Weeks
Rescue bronchodilator usage.
Time frame: 12 Weeks
Symptom scores.
Time frame: 12 Weeks
Global impression of change (patient and clinician).
Time frame: 12 Weeks
Blood sample for pharmacokinetics.
Time frame: 12 Weeks
Blood and urine sample for biomarkers and molecular profiling.
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
74 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PH-797804 in people with Pulmonary Disease, Chronic Obstructive, run by Pfizer at 74 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United States, Canada, Slovakia, Bulgaria, Czechia and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spirometry measures during 12 weeks of treatment and up to 2 weeks post treatment. (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2013.