Pulmonary Disease, Chronic ObstructivePhase 2A7881010NCT00783406
Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.
A Phase 2 study testing PF-00610355 in people with Pulmonary Disease, Chronic Obstructive, run by Pfizer at 2 sites in Germany.
Trial summary
This study will look at the pharmacokinetics, safety, toleration and efficacy of PF-00610355 in the chronic obstructive pulmonary disease (COPD) population. The doses in this study are intended to explore the anticipated clinical dose range. 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?
- PF-00610355
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2008to Mar 2009
- 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 of <0.7.
- Post bronchodilator FEV1 of 50-80% (inclusive) of predicted.
- Body Mass Index (BMI) of less than 35 kg/m2; and a total body weight greater that 40 kg.
- Current smokers, or ex-smokers who have abstained from smoking for at least 6 months.
Who cannot join
- Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
- History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Pfizer Investigational Site
Berlin, 10117
Pfizer Investigational Site
Wiesbaden, 65187
About this study
Official title: A Phase 2A, Double Blind (3rd Party Open), 4 Way Cross-Over, Placebo Controlled Study To Investigate The Pharmacokinetics, Safety, Toleration And Efficacy Of Single Inhaled Doses Of PF-00610355 In Moderate COPD Patients.
This study will look at the pharmacokinetics, safety, toleration and efficacy of PF-00610355 in the chronic obstructive pulmonary disease (COPD) population. The doses in this study are intended to explore the anticipated clinical dose range.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- PF-00610355, Placebo
- Keywords
- COPD
- 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.
PF-00610355Drug
dry powder inhaler, 1472 mcg, single dose
PF-00610355Drug
dry powder inhaler, 736 mcg, single dose
PF-00610355Drug
dry powder inhaler, 368 mcg, single dose
PlaceboDrug
Placebo
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients.
Measured: up to 8 days post dose
To evaluate the safety & toleration of single inhaled doses of PF-00610355 in COPD patients
Measured: up to 24 hours post dose
Secondary outcomes (2)
To investigate the efficacy of a single inhaled dose of PF-00610355 in COPD patients.
Measured: up to 24 hours post dose
To investigate the exposure/response relationship of PF-00610355.
Measured: up to 8 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2009
- Study completionMar 2009
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783406
- Sponsor's protocol ID
- A7881010
- Acronym
- A7881010
- Status last verified
- Oct 2010
- First submitted
- 30 Oct 2008
- Last updated
- 1 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A, Double Blind (3rd Party Open), 4 Way Cross-Over, Placebo Controlled Study To Investigate The Pharmacokinetics, Safety, Toleration And Efficacy Of Single Inhaled Doses Of PF-00610355 In Moderate COPD Patients.
- ClinicalTrials.gov ID
- NCT00783406
- Acronym / sponsor ID
- A7881010 / A7881010
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 31 Oct 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.
This study will look at the pharmacokinetics, safety, toleration and efficacy of PF-00610355 in the chronic obstructive pulmonary disease (COPD) population. The doses in this study are intended to explore the anticipated clinical dose range.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| 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 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Post-bronchodilator FEV1/ FVC ratio of <0.7.
- Post bronchodilator FEV1 of 50-80% (inclusive) of predicted.
- Body Mass Index (BMI) of less than 35 kg/m2; and a total body weight greater that 40 kg.
- Current smokers, or ex-smokers who have abstained from smoking for at least 6 months.
Key exclusion criteria (2 listed)
- Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
- History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.
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-00610355dry powder inhaler, 1472 mcg, single dose | Drug | PF- 00610355 |
| PF-00610355dry powder inhaler, 736 mcg, single dose | Drug | PF-00610355 |
| PF-00610355dry powder inhaler, 368 mcg, single dose | Drug | PF -00610355 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients.
Time frame: up to 8 days post dose
To evaluate the safety & toleration of single inhaled doses of PF-00610355 in COPD patients
Time frame: up to 24 hours post dose
2 secondary outcomes
To investigate the efficacy of a single inhaled dose of PF-00610355 in COPD patients.
Time frame: up to 24 hours post dose
To investigate the exposure/response relationship of PF-00610355.
Time frame: up to 8 days post dose
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 1 Nov 2010.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-00610355 in people with Pulmonary Disease, Chronic Obstructive, run by Pfizer at 2 sites in Germany.
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 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 1 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients. (time frame: up to 8 days post dose). The study lists 2 primary outcomes in all. 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 1 Nov 2010.