Asthma, BronchialPhase 2A7881006NCT00830427
A Study To Examine The Safety And Efficacy Of PF-00610355 In Moderately Asthmatic Subjects
A Phase 2 study testing PF-00610355 and PF - 00610355 in people with Asthma, Bronchial and Lung Diseases, Obstructive, run by Pfizer.
Trial summary
This study (A7881006) is the first multiple dose study in moderate asthmatic subjects and aims to determine the safety and efficacy of PF-00610355 when subjects take PF-00610355 on a daily basis for 4 weeks in subjects maintained on inhaled corticosteroid. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma, Bronchial, Lung Diseases, Obstructive, Respiratory Tract Diseases
- What is being tested?
- PF-00610355 and PF - 00610355
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2009to 31 Dec 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a physician documented history or diagnosis of persistent asthma for at least 6 months prior to Screening Visit 1.
- Trough FEV1 must be 50-100% of predicted at Screening Visit 1.
- Subjects who have been maintained on a stable dose of ICS over the previous month prior to screening.
Who cannot join
- Subjects who have had a severe asthma exacerbation in the 2 months prior to screening.
- Subjects meeting any of the criteria of 'very poorly controlled' according to the NIH EPR 3 guidelines.
- Subjects with evidence or history of cardiovascular disease including angina, myocardial, infarction, clinically significant cardiac arrhythmia (eg, atrial fibrillation, atrial flutter,supraventricular tachycardia, ventricular tachycardia), systemic hypertension (SBP > 160 mmHg or DBP >100mmHg), pulmonary hypertension or cerebrovascular disease (including transient ischaemic attacks).
About this study
Official title: A Phase Iib Randomised Double Blind, Placebo Controlled Parallel Group Study To Investigate The Efficacy And Safety Of Pf-00610355 Over 4 Weeks In Moderate Asthmatic Subjects.
This study (A7881006) is the first multiple dose study in moderate asthmatic subjects and aims to determine the safety and efficacy of PF-00610355 when subjects take PF-00610355 on a daily basis for 4 weeks in subjects maintained on inhaled corticosteroid.
- Conditions
- Asthma, Bronchial, Lung Diseases, Obstructive, Respiratory Tract Diseases, Bronchial Diseases
- Being tested
- PF-00610355, PF - 00610355, Placebo
- Keywords
- asthma bronchial diseases
- Medical subject headings
- Asthma, Lung Diseases, Obstructive, Respiratory Tract Diseases, Bronchial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-00610355Drug
100 mcg, QD, dry powder inhaler
PF - 00610355Drug
600 mcg, QD, dry powder inhaler
PlaceboOther
QD, dry powder inhaler
PF - 00610355Drug
300 mcg, QD, dry powder inhaler
| Study group | Role | What they receive |
|---|---|---|
| PF-00610355 | Experimental | Not described Receives: Drug: PF-00610355 |
| PF - 00610355 | Experimental | Not described Receives: Drug: PF - 00610355 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline trough (24 hours post-dose) FEV1.
Measured: 4 weeks
Secondary outcomes (5)
Change from baseline in heart rate.
Measured: week 0, week 4
Change from baseline in trough FEV1.
Measured: week 4
Maximum change from baseline in FEV1 from 0 to 6 hours post-dose.
Measured: week 0,week 4
Change from baseline in Asthma Quality of Life Questionnaire (AQLQ-S) score.
Measured: week 2, week 4
Pharmacokinetics of PF-00610355.
Measured: week 0, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study start15 Apr 2009
- Primary completion31 Dec 2009 (estimated)
- Study completion31 Dec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, BronchialStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 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
- NCT00830427
- Sponsor's protocol ID
- A7881006
- Other IDs
- 2008-007183-42, 2008
- Acronym
- A7881006
- Status last verified
- Jan 2019
- First submitted
- 26 Jan 2009
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Iib Randomised Double Blind, Placebo Controlled Parallel Group Study To Investigate The Efficacy And Safety Of Pf-00610355 Over 4 Weeks In Moderate Asthmatic Subjects.
- ClinicalTrials.gov ID
- NCT00830427
- Acronym / sponsor ID
- A7881006 / A7881006
- Conditions
- Asthma, Bronchial, Lung Diseases, Obstructive, Respiratory Tract Diseases, Bronchial Diseases
- Keywords
- asthma bronchial diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2009 (actual)
- Primary completion
- 31 Dec 2009 (estimated)
- Study completion
- 31 Dec 2009 (estimated)
- First posted
- 27 Jan 2009 (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 (A7881006) is the first multiple dose study in moderate asthmatic subjects and aims to determine the safety and efficacy of PF-00610355 when subjects take PF-00610355 on a daily basis for 4 weeks in subjects maintained on inhaled corticosteroid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PF-00610355 | Experimental | Drug: PF-00610355 |
| PF - 00610355 | Experimental | Drug: PF - 00610355 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with a physician documented history or diagnosis of persistent asthma for at least 6 months prior to Screening Visit 1.
- Trough FEV1 must be 50-100% of predicted at Screening Visit 1.
- Subjects who have been maintained on a stable dose of ICS over the previous month prior to screening.
Key exclusion criteria (3 listed)
- Subjects who have had a severe asthma exacerbation in the 2 months prior to screening.
- Subjects meeting any of the criteria of 'very poorly controlled' according to the NIH EPR 3 guidelines.
- Subjects with evidence or history of cardiovascular disease including angina, myocardial, infarction, clinically significant cardiac arrhythmia (eg, atrial fibrillation, atrial flutter,supraventricular tachycardia, ventricular tachycardia), systemic hypertension (SBP > 160 mmHg or DBP >100mmHg), pulmonary hypertension or cerebrovascular disease (including transient ischaemic attacks).
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-00610355100 mcg, QD, dry powder inhaler | Drug | PF-00610355 |
| PF - 00610355600 mcg, QD, dry powder inhaler | Drug | PF - 00610355 |
| PlaceboQD, dry powder inhaler | Other | Placebo |
| PF - 00610355300 mcg, QD, dry powder inhaler | Drug | PF - 00610355 |
Primary outcome
Change from baseline trough (24 hours post-dose) FEV1.
Time frame: 4 weeks
5 secondary outcomes
Change from baseline in heart rate.
Time frame: week 0, week 4
Change from baseline in trough FEV1.
Time frame: week 4
Maximum change from baseline in FEV1 from 0 to 6 hours post-dose.
Time frame: week 0,week 4
Change from baseline in Asthma Quality of Life Questionnaire (AQLQ-S) score.
Time frame: week 2, week 4
Pharmacokinetics of PF-00610355.
Time frame: week 0, week 4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
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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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-00610355 and PF - 00610355 in people with Asthma, Bronchial and Lung Diseases, Obstructive, run by Pfizer.
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 3 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: withdrawn, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 trough (24 hours post-dose) FEV1. (time frame: 4 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 31 Jan 2019.