AsthmaPhase 2Pin1NCT01691612
Role of the Isomerase Pin-1 in the Development and Treatment of Asthma
A Phase 2 study testing installation of D. pteronyssinus allergens in people with Asthma, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Pin1 is activated in asthmatic airways, increasing cytokine mRNA stability and eosinophil survival. This study is designed to test whether the Pin1 enzyme regulates TLR/IL-1R signal pathways in multiple cells in asthma. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- installation of D. pteronyssinus allergens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to May 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects 18-55 years of age, diagnosed with asthma for at least 1 year;
- And FEV1 > 70% predicted on only short acting beta agonists e.g albuterol
- And methacholine PC20 < 8 mg/ml
- Positive skin prick test to Dermatophagoides pteronyssinus(DerP)
- No prior history of intubation for asthma
- No use of inhaled corticosteroids for 1 month prior to entry
Who cannot join
- Current smoking or smoking history of greater than 10 pack-years
- Any other clinically important comorbidity determined by the principal investigator to affect subject safety, including uncontrolled diabetes, uncontrolled coronary artery disease, acute or chronic renal failure, and uncontrolled hypertension that would increase the risk of significant adverse events during bronchoscopy,
- Worsening of asthma symptoms requiring treatment with steroids within 4 weeks of screening
- Respiratory infection within four weeks
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant or who are currently pregnant or lactating.
- Unless they:
Show all 18Show fewer
- Are women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner
- Are women whose partners have been sterilized by vasectomy or other means
- Use one acceptable birth control method. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.
- Pre-existing lung disease other than asthma
- History of coagulation disorders or abnormal PT/PTT testing at screening
- History of immunodeficiency diseases, including HIV
- A disability that may prevent the patient from completing all study requirements
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Diagnosis of Hepatitis B or C.
- History of alcohol abuse (as determined by the principal investigator) within 6 months of screening.
- History of illicit drug abuse (as determined by the principal investigator) within 6 months of screening.
Trial locations and contacts
1 site in 1 country.
About this study
Pin1 is activated in asthmatic airways, increasing cytokine mRNA stability and eosinophil survival. This study is designed to test whether the Pin1 enzyme regulates TLR/IL-1R signal pathways in multiple cells in asthma.
Read the detailed description
The investigators will test their hypothesis that Pin1 regulates TLR/IL-1R signaling pathways in asthma by examining Pin1 and related pathway activation in BAL-derived eosinophils after house dust mite allergen challenge. The investigators will perform segmental allergen challenge. BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later and activation of Pin1 and related pathways will be examined.
- Conditions
- Asthma
- Being tested
- installation of D. pteronyssinus allergens
- Keywords
- Role of Pin-1 enzyme in Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
installation of D. pteronyssinus allergensBiological
Also called D. pteronyssinus allergens exposure
We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later
| Study group | Role | What they receive |
|---|---|---|
| D. pteronyssinus allergens | Experimental | Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments Receives: Biological: installation of D. pteronyssinus allergens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Percentage of Total White Blood Cell That Were Eosinophils at 48 Hours
Measure Pin1 activity in BAL-derived eosinophils after House Dust Mite (HDM) allergen challenge:
Eosinophils post-challenge change from pre-challenge is reported: absolute change = [eosinophils post (%) - eosinophils pre (%)]
Measured: from baseline to 48 hours
Secondary outcomes (3)
Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Lymphocytes at 48 Hours
Percent change in percentage of total white blood cell that were lymphocytes is measured from pre-challenge to post-challenge as: [100% * ((Post-Pre)/Pre)]
Measured: from baseline to 48 hours
Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Macrophages at 48 Hours
Percent change in percentage of total white blood cell that were macrophages is measured from pre-challenge to post-challenge as: [100% * ((Post-Pre)/Pre)]
Measured: from baseline to 48 hours
Change From Baseline in the Percentage of Total White Blood Cell That Were Neutrophils at 48 Hours
Neutrophils have some zero values pre-challenge, so absolute change is reported instead of percent change: post-pre from baseline to 48 hours
Measured: from baseline to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startMar 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elliot Israel, MD, Brigham and Women's Hospital
- Investigators
- Kun P Lu, M.D., PhD, Principal investigator, Beth Israel Deaconess Medical CenterElliot Israel, M.D, Principal investigator, Brigham and Womens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691612
- Sponsor's protocol ID
- 2012P001029
- Acronym
- Pin1
- Status last verified
- Jun 2017
- First submitted
- 7 Sep 2012
- Last updated
- 3 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Isomerase Pin-1 in the Development and Treatment of Asthma
- ClinicalTrials.gov ID
- NCT01691612
- Acronym / sponsor ID
- Pin1 / 2012P001029
- Conditions
- Asthma
- Keywords
- Role of Pin-1 enzyme in Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Posted 3 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pin1 is activated in asthmatic airways, increasing cytokine mRNA stability and eosinophil survival. This study is designed to test whether the Pin1 enzyme regulates TLR/IL-1R signal pathways in multiple cells in asthma.
Detailed description
The investigators will test their hypothesis that Pin1 regulates TLR/IL-1R signaling pathways in asthma by examining Pin1 and related pathway activation in BAL-derived eosinophils after house dust mite allergen challenge. The investigators will perform segmental allergen challenge. BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later and activation of Pin1 and related pathways will be examined.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| D. pteronyssinus allergens | Experimental | Biological: installation of D. pteronyssinus allergensSingle arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects 18-55 years of age, diagnosed with asthma for at least 1 year;
- And FEV1 > 70% predicted on only short acting beta agonists e.g albuterol
- And methacholine PC20 < 8 mg/ml
- Positive skin prick test to Dermatophagoides pteronyssinus(DerP)
- No prior history of intubation for asthma
Key exclusion criteria (18 listed)
- Current smoking or smoking history of greater than 10 pack-years
- Any other clinically important comorbidity determined by the principal investigator to affect subject safety, including uncontrolled diabetes, uncontrolled coronary artery disease, acute or chronic renal failure, and uncontrolled hypertension that would increase the risk of significant adverse events during bronchoscopy,
- Worsening of asthma symptoms requiring treatment with steroids within 4 weeks of screening
- Respiratory infection within four weeks
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant or who are currently pregnant or lactating.
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 |
|---|---|---|
| installation of D. pteronyssinus allergensAlso: D. pteronyssinus allergens exposureWe will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later | Biological | D. pteronyssinus allergens |
Primary outcome
Change From Baseline in the Percentage of Total White Blood Cell That Were Eosinophils at 48 Hours
Time frame: from baseline to 48 hours
Measure Pin1 activity in BAL-derived eosinophils after House Dust Mite (HDM) allergen challenge: Eosinophils post-challenge change from pre-challenge is reported: absolute change = [eosinophils post (%) - eosinophils pre (%)]
3 secondary outcomes
Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Lymphocytes at 48 Hours
Time frame: from baseline to 48 hours
Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Macrophages at 48 Hours
Time frame: from baseline to 48 hours
Change From Baseline in the Percentage of Total White Blood Cell That Were Neutrophils at 48 Hours
Time frame: from baseline to 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kun P Lu, M.D., PhD principal investigator
Beth Israel Deaconess Medical Center
Elliot Israel, M.D principal investigator
Brigham and Womens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing installation of D. pteronyssinus allergens in people with Asthma, run by Brigham and Women's Hospital at 1 site in United States.
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 6 inclusion and 18 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 3 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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?
Yes. Results are posted in the registry (first posted 3 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 the Percentage of Total White Blood Cell That Were Eosinophils at 48 Hours (time frame: from baseline to 48 hours). 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 3 Jul 2017.