Severe Persistent AsthmaNCT01745809
Bronchoscopy Study for Severe Asthma
An observational study of Severe Persistent Asthma, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this research study is to collect lung tissue and fluid from two groups of people: those who have severe asthma, and those who do not. These samples will then be tested in a laboratory to identify differences in the lung tissue cells and fluids that may exist between these two groups of people. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Persistent Asthma
- What is being tested?
- Bronchoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2014
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 10 severe asthma subjects matched with 10 healthy control subjects
Who may be able to join
- Asthma Subject Inclusion Criteria
- Subject is an adult male or female between 18 and 65 years of age inclusive.
- Subject must have a pre-history of a physician's diagnosis of severe asthma (according to GINA classification) with some reversible airway obstruction (shown by peak flow or FEV1 in the last 12 months with a change of 12% in the absolute FEV1 measurement) and an exclusion of other significant pulmonary diseases (i.e., cystic fibrosis, tuberculosis, Interstitial Lung Disease and bronchopulmonary dysplasia)
- Subject has a positive methacholine test (PC20 < 16). This test sometimes cannot be performed in severe asthmatics because of low baseline FEV1 (< FEV1 50%). SABA reversibility of FEV1 is sufficient to define asthma in absence of MCh PC20.
- Subject's asthma has been stable for the past 30 days.
- The subject has been a non-smoker for the past year and should have less than a 10 pack year history.
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- The subject must be capable of and willing to provide written informed consent
- The subject is able to understand and comply with protocol requirements and timetables, instructions and protocol-stated restrictions.
- Healthy Subject Inclusion Criteria
- Subject is an adult male or female between 18 and 65 years of age inclusive. (Subjects will be age and gender matched) With age matching, we will enroll in a manner that age and gender will be matched 1:1 in the following cohorts: age 21-30, 31-40, 41-50, 51-60, 61-65.
- Subject must have an exclusion of asthma or other significant pulmonary diseases (i.e., cystic fibrosis, tuberculosis, Interstitial Lung Disease and bronchopulmonary dysplasia)
- The subject has been a non-smoker for the past year and should have less than a 10 pack year history.
- The subject has a negative methacholine test (PC20 > 16) and does not use inhaled steroids and/or SABA.
- The subject must be capable of and willing to provide written informed consent
- The subject is able to understand and comply with protocol requirements and timetables, instructions and protocol-stated restrictions.
- -
Who cannot join
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- As a result of the medical interview, physical examination or screening investigations, the physician responsible considers the volunteer unfit for the study.
- The subject has received an investigational drug or participated in any other research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer), prior to the current study.
- No oral steroids within the last 3 months.
- No current anticoagulant and/or antiplatelet therapy.
- The subject has a history of alcohol or drug abuse within the last 5 years.
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- The subject has history of hepatitis B, hepatitis C, or HIV virus.
- The subject has a history of chemotherapy or radiotherapy within the last 2 years.
- The subject has a history of diabetes.
- The subject is pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
Airways Biology Initiative at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: An Exploratory Study to Obtain Functional and Transcriptional/Translational Profiling of Cells From Bronchial Lavages and Brushings in Severe Asthmatics and Healthy Control Subjects
The purpose of this research study is to collect lung tissue and fluid from two groups of people: those who have severe asthma, and those who do not. These samples will then be tested in a laboratory to identify differences in the lung tissue cells and fluids that may exist between these two groups of people.
- Conditions
- Severe Persistent Asthma
- Being tested
- Bronchoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyProcedure or surgery
Also called Fiberoptic Bronchoscopy, Bronchoalveolar Lavage
Subjects will have a screening visit and, if they qualify to take part in the study, they will undergo a single bronchoscopy procedure. During the bronchoscopy, bronchoalveolar lavage (BAL) and bronchial brushings will be performed on each subject.
| Study group | Role | What they receive |
|---|---|---|
| Severe Asthmatics | Subjects with a pre-existing physician diagnosis of asthma with reversible airflow obstruction of at least 12%. Receives: Procedure: Bronchoscopy | |
| Healthy non-smokers | Subjects will be never smokers or former smokers for the past year and less than 10 pack years lifetime with no history of asthma or any other lung disease. Receives: Procedure: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To obtain bronchial brushings and bronchial alveolar lavage fluid from 10 subjects with severe asthma (GINA criteria in The Global Initiative for Asthma, http://www.ginasthma.org ) and from 10 matched normal healthy subjects.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Why it stopped: Contractual issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Persistent AsthmaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Observational
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Centocor, Inc.
- Responsible party
- Sponsor
- Investigators
- Reynold Panettieri, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745809
- Sponsor's protocol ID
- 814383
- Status last verified
- Oct 2011
- First submitted
- 6 Dec 2012
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Obtain Functional and Transcriptional/Translational Profiling of Cells From Bronchial Lavages and Brushings in Severe Asthmatics and Healthy Control Subjects
- ClinicalTrials.gov ID
- NCT01745809
- Acronym / sponsor ID
- 814383
- Conditions
- Severe Persistent Asthma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Contractual issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Centocor, Inc.
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 10 Dec 2012 (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 research study is to collect lung tissue and fluid from two groups of people: those who have severe asthma, and those who do not. These samples will then be tested in a laboratory to identify differences in the lung tissue cells and fluids that may exist between these two groups of people.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe Asthmatics | – | Procedure: BronchoscopySubjects with a pre-existing physician diagnosis of asthma with reversible airflow obstruction of at least 12%. |
| Healthy non-smokers | – | Procedure: BronchoscopySubjects will be never smokers or former smokers for the past year and less than 10 pack years lifetime with no history of asthma or any other lung disease. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 10 severe asthma subjects matched with 10 healthy control subjects
Key inclusion criteria (16 listed)
- Asthma Subject Inclusion Criteria
- Healthy Subject Inclusion Criteria
- -
Key exclusion criteria (10 listed)
- <!-- -->
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 |
|---|---|---|
| BronchoscopyAlso: Fiberoptic Bronchoscopy, Bronchoalveolar LavageSubjects will have a screening visit and, if they qualify to take part in the study, they will undergo a single bronchoscopy procedure. During the bronchoscopy, bronchoalveolar lavage (BAL) and bronchial brushings will be performed on each subject. | Procedure or surgery | Healthy non-smokers, Severe Asthmatics |
Primary outcome
To obtain bronchial brushings and bronchial alveolar lavage fluid from 10 subjects with severe asthma (GINA criteria in The Global Initiative for Asthma, http://www.ginasthma.org ) and from 10 matched normal healthy subjects.
Time frame: 1 year
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 1 Jun 2015.
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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.
Reynold Panettieri, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Persistent Asthma, run by University of Pennsylvania 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 16 inclusion and 10 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 1 Jun 2015. 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.
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 obtain bronchial brushings and bronchial alveolar lavage fluid from 10 subjects with severe asthma (GINA criteria in The Global Initiative for Asthma, http://www.ginasthma.org ) and from 10 matched normal healthy subjects. (time frame: 1 year). 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 Jun 2015; AzTrials last refreshed its copy on 28 Oct 2026.