AsthmaPhase 1NCT01299467
A Study To Assess The Duration Of Action Of PF-03526299 In Asthmatic Subjects Following Allergen Challenge
A Phase 1 study testing Active (PF-03526299) in people with Asthma, run by Pfizer.
Trial summary
The purpose of this study is to find out how long the effect of PF-03526299 last after it is inhaled by assessing the lung function of mild asthma patients after they have been exposed to allergen Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- Active (PF-03526299)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Feb 2012
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and/or female subjects between the ages of 18 and 60 years, inclusive.
- A history or diagnosis of asthma that requires the use of beta 2 agonist bronchodilators (eg Salbutamol).
- Women who could become pregnant must use appropriate birth control throughout the study and pregnancy tests must be negative on entering the study and prior to dosing in the clinic.
Who cannot join
- Subjects who have been hospitalized for the treatment of asthma within three months prior to study entry, or have been hospitalized more than twice in last 12 months.
- Subjects who have experienced a lower respiratory tract infection (eg bronchitis or pneumonia) or significant asthma instability in the 4 weeks prior to study entry.
- Severe additional disease other than asthma
About this study
Official title: A Randomized, Double-Blind, Third Party Open, Double-Dummy, Placebo-Controlled, 3-Way Crossover Study To Determine The Duration Of Action Of Inhaled Doses Of PF-03526299 On Allergen-Induced Airway Responses In Mild Asthmatic Subjects
The purpose of this study is to find out how long the effect of PF-03526299 last after it is inhaled by assessing the lung function of mild asthma patients after they have been exposed to allergen
Read the detailed description
To assess duration of action of the compound in suppressing the early and late allergen response in asthma patients
- Conditions
- Asthma
- Being tested
- Active (PF-03526299), Placebo
- Keywords
- Asthma, duration of action, allergen challenge
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active (PF-03526299)Drug
Capsules for inhalation, 1.396 mg twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge
Active (PF-03526299)Drug
Capsules for inhalation, 1.396 mg twice a day for up to 12 days. Last dose given 8 hrs before allergen challenge
PlaceboDrug
Capsules for inhalation, Placebo, twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge
Active (PF-03526299)Drug
Capsules for inhalation, 4.188 mg twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge
Active (PF-03526299)Drug
Capsules for inhalation, 4.188 mg twice a day for up to 12 days. Last dose given 8hrs before allergen challenge
PlaceboDrug
Capsules for inhalation, Placebo, twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 (0.5 hours) | Experimental | Not described Receives: Drug: Active (PF-03526299) |
| Dose 1 (8 hours) | Experimental | Not described Receives: Drug: Active (PF-03526299) |
| Dose 1 (placebo) | Placebo comparator | Not described Receives: Drug: Placebo |
| Dose 2 (0.5 hr) | Experimental | Not described Receives: Drug: Active (PF-03526299) |
| Dose 2 (8 hours) | Experimental | Not described Receives: Drug: Active (PF-03526299) |
| Dose 2 (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 determine whether inhaled PF-03526299 has a sustained duration of action, using allergen-induced EAR in mild allergic asthmatics as a biomarker of response.
Measured: Up to 13 days
Secondary outcomes (3)
To determine the effect of inhaled PF-03526299 after multiple dosing on allergen-induced EAR in mild allergic asthmatics.
Measured: Up to 13 days
To determine whether inhaled PF-03526299 has a sustained duration of action, using allergen-induced LAR in mild allergic asthmatics as a biomarker of response.
Measured: Up to 13 days
To investigate the safety, toleration and pharmacokinetics of an inhaled dose of PF-03526299
Measured: Up ro 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- 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
- NCT01299467
- Sponsor's protocol ID
- A9291006
- Status last verified
- Nov 2011
- First submitted
- 3 Jan 2011
- Last updated
- 2 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Third Party Open, Double-Dummy, Placebo-Controlled, 3-Way Crossover Study To Determine The Duration Of Action Of Inhaled Doses Of PF-03526299 On Allergen-Induced Airway Responses In Mild Asthmatic Subjects
- ClinicalTrials.gov ID
- NCT01299467
- Acronym / sponsor ID
- A9291006
- Conditions
- Asthma
- Keywords
- Asthma, duration of action, allergen challenge
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 18 Feb 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.
The purpose of this study is to find out how long the effect of PF-03526299 last after it is inhaled by assessing the lung function of mild asthma patients after they have been exposed to allergen
Detailed description
To assess duration of action of the compound in suppressing the early and late allergen response in asthma patients
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose 1 (0.5 hours) | Experimental | Drug: Active (PF-03526299) |
| Dose 1 (8 hours) | Experimental | Drug: Active (PF-03526299) |
| Dose 1 (placebo) | Placebo comparator | Drug: Placebo |
| Dose 2 (0.5 hr) | Experimental | Drug: Active (PF-03526299) |
| Dose 2 (8 hours) | Experimental | Drug: Active (PF-03526299) |
| Dose 2 (placebo) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and/or female subjects between the ages of 18 and 60 years, inclusive.
- A history or diagnosis of asthma that requires the use of beta 2 agonist bronchodilators (eg Salbutamol).
- Women who could become pregnant must use appropriate birth control throughout the study and pregnancy tests must be negative on entering the study and prior to dosing in the clinic.
Key exclusion criteria (3 listed)
- Subjects who have been hospitalized for the treatment of asthma within three months prior to study entry, or have been hospitalized more than twice in last 12 months.
- Subjects who have experienced a lower respiratory tract infection (eg bronchitis or pneumonia) or significant asthma instability in the 4 weeks prior to study entry.
- Severe additional disease other than asthma
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 |
|---|---|---|
| Active (PF-03526299)Capsules for inhalation, 1.396 mg twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge | Drug | Dose 1 (0.5 hours) |
| Active (PF-03526299)Capsules for inhalation, 1.396 mg twice a day for up to 12 days. Last dose given 8 hrs before allergen challenge | Drug | Dose 1 (8 hours) |
| PlaceboCapsules for inhalation, Placebo, twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge | Drug | Dose 1 (placebo) |
| Active (PF-03526299)Capsules for inhalation, 4.188 mg twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge | Drug | Dose 2 (0.5 hr) |
| Active (PF-03526299)Capsules for inhalation, 4.188 mg twice a day for up to 12 days. Last dose given 8hrs before allergen challenge | Drug | Dose 2 (8 hours) |
| PlaceboCapsules for inhalation, Placebo, twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge | Drug | Dose 2 (placebo) |
Primary outcome
To determine whether inhaled PF-03526299 has a sustained duration of action, using allergen-induced EAR in mild allergic asthmatics as a biomarker of response.
Time frame: Up to 13 days
3 secondary outcomes
To determine the effect of inhaled PF-03526299 after multiple dosing on allergen-induced EAR in mild allergic asthmatics.
Time frame: Up to 13 days
To determine whether inhaled PF-03526299 has a sustained duration of action, using allergen-induced LAR in mild allergic asthmatics as a biomarker of response.
Time frame: Up to 13 days
To investigate the safety, toleration and pharmacokinetics of an inhaled dose of PF-03526299
Time frame: Up ro 13 days
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 2 Dec 2011.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Active (PF-03526299) in people with Asthma, 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 2 Dec 2011. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To determine whether inhaled PF-03526299 has a sustained duration of action, using allergen-induced EAR in mild allergic asthmatics as a biomarker of response. (time frame: Up to 13 days). 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 2 Dec 2011.