AsthmaNCT01537133
Airway Microbiome in Asthma: Relationships to Asthma Phenotype and Inhaled Corticosteroid Treatment
A study testing fluticasone in people with Asthma and Atopy, run by Milton S. Hershey Medical Center at 9 sites in United States.
Trial summary
There are new, very sensitive methods for detecting bacteria. These methods show that hundreds of millions of microbes (organisms that can only be seen with microscopes), especially bacteria, live in healthy people. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- fluticasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 9 sitesUnited States
- Study dates
- Oct 2012to Jul 2014
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Asthmatic:
- History of physician-diagnosed asthma.
- Methacholine PC20 < 8mg/ml and/or FEV1 improvement ≥ 12% in response to 180 mcg albuterol.
- FEV1 ≥ 70% of predicted after 180 mcg albuterol.
- Stable asthma for ≥ 3 months prior to enrollment (no urgent care visits, no systemic corticosteroid treatment).
- Asthma Control Questionnaire 6 Score < 1.5.
Show all 14Show fewer
- Able to provide informed consent.
- Able to perform spirometry as per ATS criteria.
- Evidence by allergen skin test of sensitivity to an aeroallergen.
- Willingness, if female and able to conceive, to utilize one medically-acceptable form of contraception.
- Healthy Control:
- Evidence by allergen skin test of sensitivity to an aeroallergen.
- Able to provide informed consent.
- Able to perform spirometry as per ATS criteria.
Who cannot join
- Asthmatic:
- Presence of lung disease other than asthma.
- Use of > 10 doses of nasal corticosteroids in the previous 3 months.
- Presence of significant medical illness or other chronic diseases whose treatment could affect the clinical features measured, responses to the therapies to be given in this study, or risks of participating in the study.
- History of atrial or ventricular tachyarrhythmia.
- Changes suggestive of cardiac ischemia on ECG at baseline.
Show all 28Show fewer
- History of upper respiratory infection, sinusitis, bronchitis, or antibiotic use in the previous 3 months.
- History of chronic sinus disease.
- Smoking > 5 pack-years, or within the past year
- History of long-term controller medication use for asthma (inhaled or oral corticosteroid, leukotriene pathway antagonist, cromolyn, or theophylline within the preceding 6 months.
- History of bleeding disorder.
- Reduced creatinine clearance.
- Inability, in the opinion of the Study Investigator, to coordinate use of inhaler or otherwise comply with medication regimens.
- Contraindication to bronchoscopy on history or examination.
- Healthy Control:
- History of chronic respiratory disease including asthma.
- Presence of significant medical illness or other chronic diseases whose treatment could affect the clinical features measured, responses to the therapies to be given in this study, or risks of participating in the study.
- History of atrial or ventricular tachyarrhythmia.
- Changes suggestive of cardiac ischemia on ECG at baseline.
- History of upper respiratory infection, sinusitis, bronchitis, or antibiotic use in the previous 3 months.
- Methacholine PC20 < 16 mg/ml or FEV1 improvement ≥ 12% in response to albuterol.
- History of chronic sinus disease
- Smoking > 5 pack-years, or within the past year
- Use of > 10 doses of a nasal corticosteroid preparation in the previous 3 months
- FEV1 or FVC < 80% predicted.
- History of bleeding disorder.
- Reduced creatinine clearance.
- Contraindication to bronchoscopy on history or examination.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Northwestern Memorial Hospital
Chicago, Illinois, 60611
National Jewish Health
Denver, Colorado, 80206
Duke University School of Medicine
Durham, North Carolina, 27110
University of Wisconsin
Madison, Wisconsin, 53972
University of Pittsburgh, Adult
Pittsburgh, Pennsylvania, 15213
University of California, San Francisco, Adult
San Francisco, California, 94143-0130
Washington University
St Louis, Missouri, 63110
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
There are new, very sensitive methods for detecting bacteria. These methods show that hundreds of millions of microbes (organisms that can only be seen with microscopes), especially bacteria, live in healthy people. The collection of different microbes found in a site is called a "microbiome." The investigators know that microbiomes of the skin, sinuses, mouth, gastro-intestinal tract, etc. differ from each other. The make-up of the microbiome - which bacteria are found in a site - may be necessary for good health. For example, the microbiome of the mouth is different in people with inflammation of the gums (periodontitis), and the microbiome of the bowel is different in people with inflammation of the intestinal tract (inflammatory bowel disease).
The purpose of this research study is to find out if the microbiome in the lungs is different in healthy people without asthma compared to people with asthma. This study will also find out if the microbiome of the lungs changes when people with asthma take a daily "controller" medication called an inhaled corticosteroid.
Read the detailed description
Two broad specific aims of this study are: 1)To evaluate whether the microbiota of the bronchial airways in atopic asthmatics and atopic healthy controls differ in microbial diversity, richness, evenness, or composition of specific bacterial taxa. 2) To determine whether inhaled corticosteroid treatment alters bronchial microbial community composition in asthmatics.
- Being tested
- fluticasone, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluticasoneDrug
Also called Flovent 250
Dry Powder Inhaler: 250 mcg/puff, one puff, twice a day
PlaceboDrug
Dry Powder Inhaler: Placebo
| Study group | Role | What they receive |
|---|---|---|
| Inhaled corticosteroid | Experimental | Fluticasone (250 mcg/puff, one puff, twice a day) Receives: Drug: fluticasone |
| Placebo | Placebo comparator | Placebo fluticasone (one puff, twice a day) Receives: Drug: Placebo |
| Healthy Control | No intervention | Not described |
| Atopic Non-asthmatics | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial Community Richness
Richness is the total number of different bacterial taxa detected in the sample.
Measured: baseline and after 6 weeks of treatment
Microbial Community Diversity
The Shannon diversity index is a type of entropy measure and is a function of the distribution of the total number of organisms across all of the species. If S is the total number of species in the sample and p_i is the number of organisms in the i-th species divided by the total number of organisms, then Diversity = -Σ p_i log(p_i).
Measured: baseline and after 6 weeks of treatment
Microbial Community Evenness
Pielou's evenness index is a scaled measure of biodiversity and is equal to the observed Shannon diversity index divided by the maximum possible Shannon diversity index, which would occur if all of the species in the sample were equally abundant. Evenness = D/log(S), where D is the Shannon Diversity index and log(S) is the maximum diversity of the sample.
Measured: baseline and after 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2014
- Study completionJul 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, dave mauger, Milton S. Hershey Medical Center
- Investigators
- Elliot Israel, MD, Principal investigator, Brigham and Women's HospitalLewis Smith, MD, Principal investigator, Northwestern Memorial HospitalRichard Martin, MD, Principal investigator, National Jewish HealthMario Castro, MD, Principal investigator, Washington University School of MedicineMonica Kraft, MD, Principal investigator, Duke UniversityStephen Peters, MD, Principal investigator, Wake Forest University Health SciencesHomer Boushey, MD, Principal investigator, University of California, San FranciscoSally Wenzel, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537133
- Sponsor's protocol ID
- AsthmaNet 003
- Other IDs
- U10HL098115
- Status last verified
- Nov 2016
- First submitted
- 9 Feb 2012
- Last updated
- 30 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Durack J, Christian LS, Nariya S, Gonzalez J, Bhakta NR, Ansel KM, Beigelman A, Castro M, Dyer AM, Israel E, Kraft M, Martin RJ, Mauger DT, Peters SP, Rosenberg SR, Sorkness CA, Wechsler ME, Wenzel SE, White SR, Lynch SV, Boushey HA, Huang YJ; National Heart, Lung, and Blood Institute's "AsthmaNet". Distinct associations of sputum and oral microbiota with atopic, immunologic, and clinical features in mild asthma. J Allergy Clin Immunol. 2020 Nov;146(5):1016-1026. doi: 10.1016/j.jaci.2020.03.028. Epub 2020 Apr 13.
PubMed 32298699
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Microbiome in Asthma: Relationships to Asthma Phenotype and Inhaled Corticosteroid Treatment
- ClinicalTrials.gov ID
- NCT01537133
- Acronym / sponsor ID
- AsthmaNet 003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 23 Feb 2012 (estimated)
- Results
- Posted 30 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are new, very sensitive methods for detecting bacteria. These methods show that hundreds of millions of microbes (organisms that can only be seen with microscopes), especially bacteria, live in healthy people. The collection of different microbes found in a site is called a "microbiome." The investigators know that microbiomes of the skin, sinuses, mouth, gastro-intestinal tract, etc. differ from each other. The make-up of the microbiome - which bacteria are found in a site - may be necessary for good health. For example, the microbiome of the mouth is different in people with inflammation of the gums (periodontitis), and the microbiome of the bowel is different in people with inflammation of the intestinal tract (inflammatory bowel disease).
The purpose of this research study is to find out if the microbiome in the lungs is different in healthy people without asthma compared to people with asthma. This study will also find out if the microbiome of the lungs changes when people with asthma take a daily "controller" medication called an inhaled corticosteroid.
Detailed description
Two broad specific aims of this study are: 1)To evaluate whether the microbiota of the bronchial airways in atopic asthmatics and atopic healthy controls differ in microbial diversity, richness, evenness, or composition of specific bacterial taxa. 2) To determine whether inhaled corticosteroid treatment alters bronchial microbial community composition in asthmatics.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Inhaled corticosteroid | Experimental | Drug: fluticasoneFluticasone (250 mcg/puff, one puff, twice a day) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo fluticasone (one puff, twice a day) |
| Healthy Control | No intervention | – |
| Atopic Non-asthmatics | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- History of physician-diagnosed asthma.
- Methacholine PC20 < 8mg/ml and/or FEV1 improvement ≥ 12% in response to 180 mcg albuterol.
- FEV1 ≥ 70% of predicted after 180 mcg albuterol.
- Stable asthma for ≥ 3 months prior to enrollment (no urgent care visits, no systemic corticosteroid treatment).
- Asthma Control Questionnaire 6 Score < 1.5.
Key exclusion criteria (28 listed)
- Presence of lung disease other than asthma.
- Use of > 10 doses of nasal corticosteroids in the previous 3 months.
- Presence of significant medical illness or other chronic diseases whose treatment could affect the clinical features measured, responses to the therapies to be given in this study, or risks of participating in the study.
- History of atrial or ventricular tachyarrhythmia.
- Changes suggestive of cardiac ischemia on ECG at baseline.
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 |
|---|---|---|
| fluticasoneAlso: Flovent 250Dry Powder Inhaler: 250 mcg/puff, one puff, twice a day | Drug | Inhaled corticosteroid |
| PlaceboDry Powder Inhaler: Placebo | Drug | Placebo |
Primary outcome
Microbial Community Richness
Time frame: baseline and after 6 weeks of treatment
Richness is the total number of different bacterial taxa detected in the sample.
Microbial Community Diversity
Time frame: baseline and after 6 weeks of treatment
The Shannon diversity index is a type of entropy measure and is a function of the distribution of the total number of organisms across all of the species. If S is the total number of species in the sample and p_i is the number of organisms in the i-th species divided by the total number of organisms, then Diversity = -Σ p_i log(p_i).
Microbial Community Evenness
Time frame: baseline and after 6 weeks of treatment
Pielou's evenness index is a scaled measure of biodiversity and is equal to the observed Shannon diversity index divided by the maximum possible Shannon diversity index, which would occur if all of the species in the sample were equally abundant. Evenness = D/log(S), where D is the Shannon Diversity index and log(S) is the maximum diversity of the sample.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32298699Durack J, Christian LS, Nariya S, Gonzalez J, Bhakta NR, Ansel KM, Beigelman A, Castro M, Dyer AM, Israel E, Kraft M, Martin RJ, Mauger DT, Peters SP, Rosenberg SR, Sorkness CA, Wechsler ME, Wenzel SE, White SR, Lynch SV, Boushey HA, Huang YJ; National Heart, Lung, and Blood Institute's "AsthmaNet". Distinct associations of sputum and oral microbiota with atopic, immunologic, and clinical features in mild asthma. J Allergy Clin Immunol. 2020 Nov;146(5):1016-1026. doi: 10.1016/j.jaci.2020.03.028. Epub 2020 Apr 13.
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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.
Elliot Israel, MD principal investigator
Brigham and Women's Hospital
Lewis Smith, MD principal investigator
Northwestern Memorial Hospital
Richard Martin, MD principal investigator
National Jewish Health
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluticasone in people with Asthma and Atopy, run by Milton S. Hershey Medical Center at 9 sites 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 14 inclusion and 28 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 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2016). 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?
Microbial Community Richness (time frame: baseline and after 6 weeks of treatment). The study lists 3 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 NCT01537133, 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 30 Nov 2016.