AsthmaSARPIIINCT01748175
Implications and Stability of Clinical and Molecular Phenotypes of Severe Asthma
An observational study of Asthma and Severe Persistent Asthma, run by Sally E. Wenzel MD at 1 site in United States.
Trial summary
The Severe Asthma Research Program III is an NIH cooperative agreement involving 7 clinical centers that encompass a multidisciplinary partnerships between asthma clinician-scientists and scientists with expertise in immunology, pulmonary physiology, molecular genetics, molecular phenotyping, imaging, and… Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma, Severe Persistent Asthma
- What is being tested?
- Triamcinolone Acetonide
- Type of treatment
- Injection or infusion
- How many people
- 715 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2022
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with asthma meeting inclusion and exclusion criteria will be recruited from 7 SARP III participating clinical centers. The clinical centers are located at Brigham and Women's Hospital (with co-investigators at Children's Hospital), the University of California San Francisco, the University of Pittsburgh, the University of Virginia (with co-investigators at the Cleveland Clinic, Case Western Reserve and Virginia Commonwealth University), the University of Wisconsin, Wake Forest School of Medicine (with co-investigators at Emory University), and Washington University in St. Louis (with co-investigators at the University of Iowa).
Who may be able to join
- Previous asthma diagnosis
- FEV1 bronchodilator reversibility ≥12% or airway hyperresponsiveness reflected by a methacholine PC20 ≤16 mg/mL (Historical methacholine data from previous NIH trial [SARP I or II, AsthmaNet, ALA-ACRC, ACRN or CARE] will be allowed).
- Healthy subjects between the age of 18 and 65
- At least 3 of the 7 subjects per center should be aged 35 or older
Who cannot join
- Pregnancy during the characterization phase
- Current smoking,
- Smoking history > 10 pack years if ≥30 years of age, or smoking history > 5 pack years if <30 years of age (Note: if a subject has a smoking history, no smoking within the past year),
- Other chronic pulmonary disorders associated with asthma-like symptoms, including (but not limited to) cystic fibrosis, chronic obstructive pulmonary disease, chronic bronchitis, vocal cord dysfunction (that is the sole cause of respiratory symptoms and at the PI's discretion), severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways,
- History of premature birth before 35 weeks gestation,
- Unwillingness to receive an intramuscular triamcinolone acetonide injection.
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- Evidence that the participant or family may be unreliable or poorly adherent to their asthma treatment or study procedures,
- Planning to relocate from the clinical center area before study completion,
- Any other criteria that place the subject at unnecessary risk according to the judgment of the Principal Investigator and/or attending physician(s) of record, or
- Currently participating in an investigational drug trial.
- Healthy Controls:
- History of chronic diseases that affect the lungs: Chronic airway disease (asthma, cystic fibrosis, COPD, chronic bronchitis, bronchiectasis); Interstitial lung disease, sarcoidosis, occupational lung disease; Obstructive sleep apnea; Vocal cord dysfunction; Severe scoliosis or chest wall deformities.
- A history suggestive of allergic rhinitis (based on the best judgment of the physician investigator).
- A history of eczema.
- Chronic sinusitis.
- An improvement in FEV1 of more than 12% following 4 puffs of albuterol.
- Chronic systemic diseases requiring ongoing anti-inflammatory treatment.
- Current use of beta adrenergic blocking agent or a cholinesterase inhibitor (medicine used to treat myasthenia gravis or Alzheimer's disease).
- Smoking history > 10 pack years if ≥30 years of age, or smoking history > 5 pack years if <30 years of age (Note: if a subject has a smoking history, no smoking within the past year).
- Respiratory tract infection within the past 4 weeks.
- Pregnancy.
- History of premature birth (<35 weeks).
- Any other criteria that place the subject at increased risk of complications from study procedures, according to the judgment of the Principal Investigator and/or attending physician(s) of record.
Trial locations and contacts
1 site in 1 country.
United States1 site
Asthma Institute, UNiversity of Pittsburgh and University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213
About this study
The Severe Asthma Research Program III is an NIH cooperative agreement involving 7 clinical centers that encompass a multidisciplinary partnerships between asthma clinician-scientists and scientists with expertise in immunology, pulmonary physiology, molecular genetics, molecular phenotyping, imaging, and bioinformatics. These clinical centers will jointly recruit volunteers with asthma for an observational longitudinal follow-up study. However, centers will also conduct specific mechanistic research projects at each participating institution. The University of Pittsburgh's SARP III study will determine the molecular and clinical stability of asthma phenotypes over time.
Read the detailed description
The longitudinal follow-up study is divided into a characterization and longitudinal phase. During the characterization subjects will undergo a baseline evaluation that will include will include answering questionnaires, lung function testing, and chest tomography. Subsequently, to determine steroid responsiveness, all subjects will receive one intramuscular dose of 40 mg in 1ml (1 mg/kg for children <18 years old, up to 40 mg maximum. Participants at the University of Pittsburgh will undergo a bronchoscopy to provide airway samples. The longitudinal phase will include a 36 month follow-up time with annual visits and phone calls every 6 months. During it, participants will answer questionnaires and provide sputum samples on two occasions, and will perform lung function testing.
The SARP III longitudinal follow up study (all centers) will determine the long term stability and implications of clinical and molecular asthma phenotypes and identify potential systemic biomarkers for these phenotypes
The University of Pittsburgh center will test the hypothesis that a) a mast cell signature is present and longitudinally maintained in severe asthma; and b) That the persistent signature determines short and long term outcomes through interactions with lung and inflammatory cells.
- Conditions
- Asthma, Severe Persistent Asthma
- Being tested
- Triamcinolone Acetonide
- Keywords
- Severe asthma, longitudinal study, phenotypes
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone AcetonideDrug
Also called Kenalog
Each subject that meets inclusion/exclusion criteria will receive triamcinolone acetonide intramuscularly at the end of visit 2. Adults ≥18 years will receive 40 mg triamcinolone acetonide. Children 6-17 years will receive 1 mg/kg triamcinolone acetonide (up to 40 mg maximum). Triamcinolone acetonide will be administered as a single intramuscular dose deep in the gluteal region
| Study group | Role | What they receive |
|---|---|---|
| Longitudinal follow up | Patients will undergo a characterization phase, which includes a baseline evaluation (1 visit), and a steroid responsiveness evaluation (2 visits). The longitudinal phase will include 3 office visits (annually) over 36 months with bi-annual phone calls. During the study patients will answer questionnaires, perform lung function testing and provide blood, urine, sputum and exhaled breath condensate samples. Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway lumen mast cells
Determine the impact of mast cell markers on human airway epithelial cell phenotype and function.
Measured: Once, during bronchoscopy
Longitudinal asthma phenotype
Determine the long term stability and implications of previously identified clinical and molecular asthma phenotypes, specifically the mast cell signature, and identify potential systemic biomarkers for these phenotypes.
Determine whether a biomarker for the lung mast cell signature can be identified in serum/plasma of both adult and pediatric severe asthmatics
Measured: Change rates, determined annually for three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2021
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 715 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sally E. Wenzel MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sally E. Wenzel MD, University of Pittsburgh
- Investigators
- Sally E Wenzel, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748175
- Sponsor's protocol ID
- 1010HL109152-01
- Acronym
- SARPIII
- Status last verified
- Sep 2022
- First submitted
- 27 Nov 2012
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
DeBoer MD, Phillips BR, Mauger DT, Zein J, Erzurum SC, Fitzpatrick AM, Gaston BM, Myers R, Ross KR, Chmiel J, Lee MJ, Fahy JV, Peters M, Ly NP, Wenzel SE, Fajt ML, Holguin F, Moore WC, Peters SP, Meyers D, Bleecker ER, Castro M, Coverstone AM, Bacharier LB, Jarjour NN, Sorkness RL, Ramratnam S, Irani AM, Israel E, Levy B, Phipatanakul W, Gaffin JM, Gerald Teague W. Effects of endogenous sex hormones on lung function and symptom control in adolescents with asthma. BMC Pulm Med. 2018 Apr 10;18(1):58. doi: 10.1186/s12890-018-0612-x.
PubMed 29631584
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications and Stability of Clinical and Molecular Phenotypes of Severe Asthma
- ClinicalTrials.gov ID
- NCT01748175
- Acronym / sponsor ID
- SARPIII / 1010HL109152-01
- Conditions
- Asthma, Severe Persistent Asthma
- Keywords
- Severe asthma, longitudinal study, phenotypes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 715 participants (actual)
- Lead sponsor
- Sally E. Wenzel MDUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2021 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 12 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 Severe Asthma Research Program III is an NIH cooperative agreement involving 7 clinical centers that encompass a multidisciplinary partnerships between asthma clinician-scientists and scientists with expertise in immunology, pulmonary physiology, molecular genetics, molecular phenotyping, imaging, and bioinformatics. These clinical centers will jointly recruit volunteers with asthma for an observational longitudinal follow-up study. However, centers will also conduct specific mechanistic research projects at each participating institution. The University of Pittsburgh's SARP III study will determine the molecular and clinical stability of asthma phenotypes over time.
Detailed description
The longitudinal follow-up study is divided into a characterization and longitudinal phase. During the characterization subjects will undergo a baseline evaluation that will include will include answering questionnaires, lung function testing, and chest tomography. Subsequently, to determine steroid responsiveness, all subjects will receive one intramuscular dose of 40 mg in 1ml (1 mg/kg for children <18 years old, up to 40 mg maximum. Participants at the University of Pittsburgh will undergo a bronchoscopy to provide airway samples. The longitudinal phase will include a 36 month follow-up time with annual visits and phone calls every 6 months. During it, participants will answer questionnaires and provide sputum samples on two occasions, and will perform lung function testing.
The SARP III longitudinal follow up study (all centers) will determine the long term stability and implications of clinical and molecular asthma phenotypes and identify potential systemic biomarkers for these phenotypes
The University of Pittsburgh center will test the hypothesis that a) a mast cell signature is present and longitudinally maintained in severe asthma; and b) That the persistent signature determines short and long term outcomes through interactions with lung and inflammatory cells.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Longitudinal follow up | – | Drug: Triamcinolone AcetonidePatients will undergo a characterization phase, which includes a baseline evaluation (1 visit), and a steroid responsiveness evaluation (2 visits). The longitudinal phase will include 3 office visits (annually) over 36 months with bi-annual phone calls. During the study patients will answer questionnaires, perform lung function testing and provide blood, urine, sputum and exhaled breath condensate samples. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with asthma meeting inclusion and exclusion criteria will be recruited from 7 SARP III participating clinical centers. The clinical centers are located at Brigham and Women's Hospital (with co-investigators at Children's Hospital), the University of California San Francisco, the University of Pittsburgh, the University of Virginia (with co-investigators at the Cleveland Clinic, Case Western Reserve and Virginia Commonwealth University), the University of Wisconsin, Wake Forest School of Medicine (with co-investigators at Emory University), and Washington University in St. Louis (with co-investigators at the University of Iowa).
Key inclusion criteria (4 listed)
- Previous asthma diagnosis
- FEV1 bronchodilator reversibility ≥12% or airway hyperresponsiveness reflected by a methacholine PC20 ≤16 mg/mL (Historical methacholine data from previous NIH trial [SARP I or II, AsthmaNet, ALA-ACRC, ACRN or CARE] will be allowed).
- Healthy subjects between the age of 18 and 65
- At least 3 of the 7 subjects per center should be aged 35 or older
Key exclusion criteria (23 listed)
- Pregnancy during the characterization phase
- Current smoking,
- Smoking history > 10 pack years if ≥30 years of age, or smoking history > 5 pack years if <30 years of age (Note: if a subject has a smoking history, no smoking within the past year),
- Other chronic pulmonary disorders associated with asthma-like symptoms, including (but not limited to) cystic fibrosis, chronic obstructive pulmonary disease, chronic bronchitis, vocal cord dysfunction (that is the sole cause of respiratory symptoms and at the PI's discretion), severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways,
- History of premature birth before 35 weeks gestation,
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 |
|---|---|---|
| Triamcinolone AcetonideAlso: KenalogEach subject that meets inclusion/exclusion criteria will receive triamcinolone acetonide intramuscularly at the end of visit 2. Adults ≥18 years will receive 40 mg triamcinolone acetonide. Children 6-17 years will receive 1 mg/kg triamcinolone acetonide (up to 40 mg maximum). Triamcinolone acetonide will be administered as a single intramuscular dose deep in the gluteal region | Drug | Longitudinal follow up |
Primary outcome
Airway lumen mast cells
Time frame: Once, during bronchoscopy
Determine the impact of mast cell markers on human airway epithelial cell phenotype and function.
Longitudinal asthma phenotype
Time frame: Change rates, determined annually for three years
Determine the long term stability and implications of previously identified clinical and molecular asthma phenotypes, specifically the mast cell signature, and identify potential systemic biomarkers for these phenotypes. Determine whether a biomarker for the lung mast cell signature can be identified in serum/plasma of both adult and pediatric severe asthmatics
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 16 Sep 2022.
- Derived from this study: PubMed 29631584DeBoer MD, Phillips BR, Mauger DT, Zein J, Erzurum SC, Fitzpatrick AM, Gaston BM, Myers R, Ross KR, Chmiel J, Lee MJ, Fahy JV, Peters M, Ly NP, Wenzel SE, Fajt ML, Holguin F, Moore WC, Peters SP, Meyers D, Bleecker ER, Castro M, Coverstone AM, Bacharier LB, Jarjour NN, Sorkness RL, Ramratnam S, Irani AM, Israel E, Levy B, Phipatanakul W, Gaffin JM, Gerald Teague W. Effects of endogenous sex hormones on lung function and symptom control in adolescents with asthma. BMC Pulm Med. 2018 Apr 10;18(1):58. doi: 10.1186/s12890-018-0612-x.
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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.
Sally E Wenzel, MD principal investigator
University of Pittsburgh
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 Asthma and Severe Persistent Asthma, run by Sally E. Wenzel MD 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 4 inclusion and 23 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 16 Sep 2022. 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 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?
Airway lumen mast cells (time frame: Once, during bronchoscopy). 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?
On the ClinicalTrials.gov record for NCT01748175, which also lists 1 linked publication.
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 16 Sep 2022.