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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Asthma, Atopy
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.

City, postcode or hospital

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

Other trials in United States

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.

Conditions: Asthma, Atopy
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 groups in NCT01537133
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.

Oct 2012Jul 2014

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
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All Asthma trials

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
Conditions: Asthma, Atopy
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.

Detailed description

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

Results posted to the registry on 30 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Inhaled Corticosteroid	28	25
Placebo	14	14
Healthy Control	21	21
Atopic Non-asthmatics	21	21

Primary outcome: Microbial Community Richness

Time frame: baseline and after 6 weeks of treatment. Median (Inter-Quartile Range). Unit: number of bacterial taxa

Measure	Atopic Asthmatics Treated With Inhaled Corticosteroids n = 16	Atopic Asthmatics Treated With Placebo n = 12	Atopic Non-asthmatics n = 15	Healthy Control n = 13
baseline	449 (376 to 613)	543 (484 to 684)	483 (437 to 646)	444 (400 to 530)
after 6 weeks of treatment	456 (351 to 578)	405 (385 to 714)	NA (NA to NA)	NA (NA to NA)

Population analysed: Only baseline samples were collected from atopic non-asthmatics and healthy controls. Data was not available for all participants due to insufficient amplification in some samples.

Primary outcome: Microbial Community Diversity

Time frame: baseline and after 6 weeks of treatment. Median (Inter-Quartile Range). Unit: Shannon Diversity Index

Measure	Atopic Asthmatics Treated With Inhaled Corticosteroids n = 16	Atopic Asthmatics Treated With Placebo n = 12	Atopic Non-asthmatics n = 15	Healthy Control n = 13
baseline	5.4 (4.9 to 5.6)	5.7 (5.0 to 6.0)	5.6 (5.2 to 6.0)	5.3 (5.2 to 5.5)
after 6 weeks of treatment	5.0 (4.6 to 5.7)	5.1 (4.8 to 5.7)	NA (NA to NA)	NA (NA to NA)

Primary outcome: Microbial Community Evenness

Time frame: baseline and after 6 weeks of treatment. Median (Inter-Quartile Range). Unit: Pielou's evenness index

Measure	Atopic Asthmatics Treated With Inhaled Corticosteroids n = 16	Atopic Asthmatics Treated With Placebo n = 12	Atopic Non-asthmatics n = 15	Healthy Control n = 13
baseline	0.88 (0.81 to 0.90)	0.88 (0.79 to 0.91)	0.90 (0.83 to 0.94)	0.86 (0.83 to 0.91)
after 6 weeks of treatment	0.85 (0.76 to 0.90)	0.86 (0.81 to 0.88)	NA (NA to NA)	NA (NA to NA)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Inhaled Corticosteroid	0 of 28 (0%)	2 of 28 (7.1%)	Not reported
Placebo	0 of 14 (0%)	2 of 14 (14.3%)	Not reported

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.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
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RecruitingPhase 3
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Active, not recruitingPhase 2/3
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RecruitingPhase 2
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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.