Pulmonary Disease, Chronic ObstructivePhase 2A7881013NCT00808288
A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.
A Phase 2 study testing PF-00610355, PF - 00610355 and PF- 00610355 in people with Pulmonary Disease, Chronic Obstructive and Lung Diseases, run by Pfizer at 75 sites in 12 countries.
Trial summary
To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD) Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Lung Diseases, Obstructive
- What is being tested?
- PF-00610355, PF - 00610355 and PF- 00610355
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 405 participants
- Where
- 75 sitesin 12 countries
- Study dates
- Mar 2010to Dec 2010
- 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
- Post-bronchodilator FEV1/FVC ratio <0.7 and a post-bronchodilator FEV1 of 50-80%.
- Diagnosis of moderate COPD for a minimum of 6 months.
- Stable disease for at least 1 month prior to screening
Who cannot join
- More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalisation for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
- History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomisation.
Trial locations and contacts
75 sites in 12 countries.
75 sites in 12 countries
United States30 sites
Pfizer Investigational Site
Austell, Georgia, 30106
Pfizer Investigational Site
Charleston, South Carolina, 29407
Pfizer Investigational Site
Charleston, South Carolina, 29414
Pfizer Investigational Site
Charlotte, North Carolina, 28207
Pfizer Investigational Site
Cincinnati, Ohio, 45227
Pfizer Investigational Site
Cincinnati, Ohio, 45231
Pfizer Investigational Site
Cincinnati, Ohio, 45242
Pfizer Investigational Site
Cincinnati, Ohio, 45245
Pfizer Investigational Site
Columbia, South Carolina, 29204
Pfizer Investigational Site
Daytona Beach, Florida, 32114
Pfizer Investigational Site
Fairhope, Alabama, 36532
Pfizer Investigational Site
Fridley, Minnesota, 55432
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Lincoln, Rhode Island, 02865
Pfizer Investigational Site
Minneapolis, Minnesota, 55407
Pfizer Investigational Site
Morgantown, West Virginia, 26505
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73112
Pfizer Investigational Site
Ormond Beach, Florida, 32174
Pfizer Investigational Site
Overland Park, Kansas, 66211
Pfizer Investigational Site
Overland Park, Kansas, 66212
Pfizer Investigational Site
Pawtucket, Rhode Island, 02860
Pfizer Investigational Site
Rochester, Minnesota, 55905
Pfizer Investigational Site
Rochester, New York, 14618
Pfizer Investigational Site
San Antonio, Texas, 78212
Pfizer Investigational Site
San Diego, California, 92120
Pfizer Investigational Site
Spring Valley, California, 91978
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Tampa, Florida, 33613
Pfizer Investigational Site
Trinity, Florida, 34655
Pfizer Investigational Site
Wheat Ridge, Colorado, 80033
Germany8 sites
Pfizer Investigational Site
Berlin, 12687
Pfizer Investigational Site
Berlin, 14057
Pfizer Investigational Site
Frankfurt, 60596
Pfizer Investigational Site
Hamburg, 20354
Pfizer Investigational Site
Kassel, 34121
Pfizer Investigational Site
Lübeck, 23552
Pfizer Investigational Site
Schwerin, 19055
Pfizer Investigational Site
Wiesbaden, 65187
Slovakia6 sites
Pfizer Investigational Site
Bojnice, 972 01
Pfizer Investigational Site
Bratislava, 826 06
Pfizer Investigational Site
Liptovský Hrádok, 033 01
Pfizer Investigational Site
Nové Zámky, 940 01
Pfizer Investigational Site
Poprad, 058 01
Pfizer Investigational Site
Spišská Nová Ves, 052 01
Bulgaria5 sites
Pfizer Investigational Site
Rousse, 7002
Pfizer Investigational Site
Sofia, 1431
Pfizer Investigational Site
Sofia, 1606
Pfizer Investigational Site
Stara Zagora, 6003
Pfizer Investigational Site
Troyan Municipality, 5600
Hungary5 sites
Pfizer Investigational Site
Budapest, 1125
Pfizer Investigational Site
Debrecen, 4012
Pfizer Investigational Site
Szeged, 6772
Pfizer Investigational Site
Szombathely, 9700
Pfizer Investigational Site
Törökbálint, 2045
South Africa5 sites
Pfizer Investigational Site
Bellville, Cape Town, 7530
Pfizer Investigational Site
Bloemfontein, Free State, 9301
Pfizer Investigational Site
Bloemfontein
Pfizer Investigational Site
Gatesville, Cape Town, 7764
Pfizer Investigational Site
Tygerberg, Cape Town, 7505
Czechia4 sites
Pfizer Investigational Site
Kutná Hora, 283 01
Pfizer Investigational Site
Liberec, 460 01
Pfizer Investigational Site
Prague, 153 00
Pfizer Investigational Site
Tábor, 39001
Poland4 sites
Pfizer Investigational Site
Lodz, 90-153
Pfizer Investigational Site
Sopot, 81-741
Pfizer Investigational Site
Warsaw, 04-141
Pfizer Investigational Site
Wejherowo, 84-200
Argentina3 sites
Pfizer Investigational Site
Buenos Aires, 1426
Pfizer Investigational Site
Buenos Aires, C1405BCH
Pfizer Investigational Site
Rosario, Santa Fe Province, 2000
Spain2 sites
Pfizer Investigational Site
Pozuelo de Alarcón, Madrid, 28223
Pfizer Investigational Site
Salt, Girona, 17190
Turkey (Türkiye)2 sites
Pfizer Investigational Site
Istanbul, 34098
Pfizer Investigational Site
Izmir, 35100
About this study
Official title: A Phase 2b, Parallel Group, Placebo And Active Comparator Controlled Study To Investigate The Safety, Toleration And Efficacy Of 6-Week Once Daily Administration Of Inhaled PF-00610355 Dry Powder In Patients With Moderate Chronic Obstructive Pulmonary Disease.
To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD)
- Being tested
- PF-00610355, PF - 00610355, PF- 00610355, Placebo, Salmeterol
- Keywords
- COPD Respiratory Long acting beta agonist
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-00610355Drug
oral, inhaled, dry powder, 600ug, OD
PF - 00610355Drug
oral, inhaled, dry powder, 300ug, OD
PF- 00610355Drug
oral, inhaled, dry powder, 100ug, OD
PlaceboDrug
oral, inhaled, dry powder, placebo, OD
SalmeterolDrug
salmeterol, 50ug, BID
| Study group | Role | What they receive |
|---|---|---|
| PF-00610355 | Experimental | Not described Receives: Drug: PF-00610355 |
| PF- 00610355 | Experimental | Not described Receives: Drug: PF - 00610355 |
| PF - 00610355 | Experimental | Not described Receives: Drug: PF- 00610355 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Salmeterol | Active comparator | Not described Receives: Drug: Salmeterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in trough FEV1
Measured: 6 week
Secondary outcomes (6)
Maximal and mean changes from baseline in heart rate, QTc and plasma potassium
Measured: each visit
Change from baseline in peak FEV1
Measured: 0-6 hours /6 weeks
Change from baseline in trough and peak FEV6, FVC and IC
Measured: 6 weeks
Change from baseline in trough FEV1, FEV6, forced vital capacity (FVC) and inspiratory capacity (IC)
Measured: 2 and 4 weeks
Change from baseline in Respiratory Questionnaire Self-Administered Standardised (CRQ-SAS)
Measured: 2,4,6 weeks
Change from baseline of COPD symptoms and rescue bronchodilator use (per daily diary).
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startMar 2010
- Primary completionDec 2010
- Study completionDec 2010
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 405 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
- NCT00808288
- Sponsor's protocol ID
- A7881013
- Acronym
- A7881013
- Status last verified
- Feb 2019
- First submitted
- 12 Dec 2008
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Parallel Group, Placebo And Active Comparator Controlled Study To Investigate The Safety, Toleration And Efficacy Of 6-Week Once Daily Administration Of Inhaled PF-00610355 Dry Powder In Patients With Moderate Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT00808288
- Acronym / sponsor ID
- A7881013 / A7881013
- Keywords
- COPD Respiratory Long acting beta agonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Dec 2008 (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.
To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PF-00610355 | Experimental | Drug: PF-00610355 |
| PF- 00610355 | Experimental | Drug: PF - 00610355 |
| PF - 00610355 | Experimental | Drug: PF- 00610355 |
| Placebo | Placebo comparator | Drug: Placebo |
| Salmeterol | Active comparator | Drug: Salmeterol |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Post-bronchodilator FEV1/FVC ratio <0.7 and a post-bronchodilator FEV1 of 50-80%.
- Diagnosis of moderate COPD for a minimum of 6 months.
- Stable disease for at least 1 month prior to screening
Key exclusion criteria (2 listed)
- More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalisation for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
- History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomisation.
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 |
|---|---|---|
| PF-00610355oral, inhaled, dry powder, 600ug, OD | Drug | PF-00610355 |
| PF - 00610355oral, inhaled, dry powder, 300ug, OD | Drug | PF- 00610355 |
| PF- 00610355oral, inhaled, dry powder, 100ug, OD | Drug | PF - 00610355 |
| Placebooral, inhaled, dry powder, placebo, OD | Drug | Placebo |
| Salmeterolsalmeterol, 50ug, BID | Drug | Salmeterol |
Primary outcome
Change from baseline in trough FEV1
Time frame: 6 week
6 secondary outcomes
Maximal and mean changes from baseline in heart rate, QTc and plasma potassium
Time frame: each visit
Change from baseline in peak FEV1
Time frame: 0-6 hours /6 weeks
Change from baseline in trough and peak FEV6, FVC and IC
Time frame: 6 weeks
Change from baseline in trough FEV1, FEV6, forced vital capacity (FVC) and inspiratory capacity (IC)
Time frame: 2 and 4 weeks
Change from baseline in Respiratory Questionnaire Self-Administered Standardised (CRQ-SAS)
Time frame: 2,4,6 weeks
Change from baseline of COPD symptoms and rescue bronchodilator use (per daily diary).
Time frame: weekly
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 6 Feb 2019.
- 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
75 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-00610355, PF - 00610355 and PF- 00610355 in people with Pulmonary Disease, Chronic Obstructive and Lung Diseases, run by Pfizer at 75 sites in 12 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 3 inclusion and 2 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 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, Germany, Slovakia, Bulgaria, Hungary and 7 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?
Change from baseline in trough FEV1 (time frame: 6 week). 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 6 Feb 2019.