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Inability to accrue patients, particularly after COVID pandemic.
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| Name | Class |
|---|---|
| Northwestern University | OTHER |
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The purpose of this study to determine whether the bacteria inside the lungs of people with asthma can be modified (changed) if they are given an antibiotic and if this change is associated with an improvement in asthma symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 8 weeks of placebo capsule once daily by mouth |
|
| Azithromycin | Active Comparator | 8 weeks of Azithromycin (250 mg) capsule once daily by mouth |
|
| Non-asthmatic controls | No Intervention | Non-asthmatic controls to assess variability of microbiome composition and diversity over time in a normal population. No intervention given. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | 8 weeks of Azithromycin (250 mg) once daily by mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Test (ACT) Score Change From Baseline Over 8 Weeks | Score ranging from 0 to 40 indicating the degree of asthma symptoms. Lower score indicating worse asthma symptoms. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume (FEV1) Change From Baseline Over 8 Weeks | Volume of air exhaled in 1 second on a forced expiration, expressed as percent of predicted, indicating the degree of airflow obstruction in asthma | 8 weeks |
| Sputum Eosinophils Change From Baseline Over 8 Weeks |
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Inclusion criteria (All participants):
Inclusion Criteria for subjects with poorly controlled asthma
Exclusion Criteria (All participants)
History of allergy or intolerance to any medications used in this study
Medication exclusions:
Prednsione or other oral steroids within past 3 months
Pregnancy or lactation, or plans to become pregnant
Other respiratory or inflammatory disorders (e.g., sarcoidosis, emphysema)
Pre-existing liver disease by history
Smoking within the last 6 months
Exacerbation of asthma in past 3 months
Affected by a hearing disorder
Clinically significant medical condition (e.g., heart failure, seizure disorder) which may in-crease risk as determined by study investigator
Corrected QT interval > 450 msec. Patients with known cardiac history or prolonged QT interval on a screening EKG are excluded given the small but real potential for macrolide-related side effects
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| Name | Affiliation | Role |
|---|---|---|
| Steve White, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60201 | United States | ||
| University of Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33032168 | Result | Vogelmeier CF, Fuhlbrigge A, Jauhiainen A, Scheepers LEJM, Bengtsson T, Peterson S, Karlsson N, Sethi T, Locantore N, Tal-Singer R, Rennard S, Fageras M, Da Silva CA. COPDCompEx: A novel composite endpoint for COPD exacerbations to enable faster clinical development. Respir Med. 2020 Nov;173:106175. doi: 10.1016/j.rmed.2020.106175. Epub 2020 Sep 28. |
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We will share individual participant data that is de-identified available to all qualified investigators
Upon publication of the major manuscript to be generated from this study. Data will be deposited in an appropriate major database (e.g., sequencing information will be deposited in a genetics bio-bank).
All qualified investigators who sign appropriate data use agreements and material transfer agreements with the University of Chicago and Northwestern University
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 8 weeks of placebo capsule once daily by mouth Placebo: Placebo |
| FG001 | Azithromycin | 8 weeks of Azithromycin (250 mg) capsule once daily by mouth Azithromycin: 8 weeks of Azithromycin (250 mg) once daily by mouth |
| FG002 | Non-asthmatic Controls | Non-asthmatic controls to assess variability of microbiome composition and diversity over time in a normal population. No intervention given. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 8 weeks of placebo capsule once daily by mouth Placebo: Placebo |
| BG001 | Azithromycin | 8 weeks of Azithromycin (250 mg) capsule once daily by mouth Azithromycin: 8 weeks of Azithromycin (250 mg) once daily by mouth |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Asthma Control Test (ACT) Score Change From Baseline Over 8 Weeks | Score ranging from 0 to 40 indicating the degree of asthma symptoms. Lower score indicating worse asthma symptoms. | Outcome variable is not applicable to non-asthmatic controls, as they were not assessed for asthma symptoms. | Posted | Mean | Standard Error | score on a scale | Baseline and 8 weeks |
|
14 weeks Note: Adverse events were not collected in the Non-asthmatic controls.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 8 weeks of placebo capsule once daily by mouth Placebo: Placebo | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
Early termination leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Theodore Karrison (Research Professor) | University of Chicago | 773-702-9326 | tkarrison@health.bsd.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2018 | Oct 25, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Placebo | Drug | Placebo |
|
Percentage of 'eosinophils', an inflammatory cell seen in the airways of people with asthma, indicating the degree of inflammation |
| Baseline and 8 weeks |
| Sputum Neutrophils Change From Baseline Over 8 Weeks | Percentage of 'neutrophils', an inflammatory cell seen in the airways of people with asthma, indicating the degree of inflammation | Baseline and 8 weeks |
| Number of Participants With Diary Event or Serious Asthma Exacerbation Over 8 Weeks | The outcome is derived from a weighted scoring system called CompEx that describes asthma symptoms recorded on a daily basis. Final result is a dichotomous outcome indicating whether the patient had a "diary event" based on changes in peak expiratory flow, reliever use, and asthma symptoms or a serious exacerbation (deterioration of asthma leading to oral corticosteroid use, emergency room admission, or hospital admission). | 8 weeks |
| Microbiome Shannon Alpha-diversity Score Change From Baseline to 8 Weeks | A measure of the diversity of the bacteria in the sputum or oral sample; that is, how many different types of bacteria are present. This value decreases in severe asthma | 8 weeks |
| Microbiome Beta-diversity Score Change From Baseline to 8 Weeks | A second measure of the diversity of the bacteria in the sputum or oral sample; that is, how many different types of bacteria are present. This value decreases in severe asthma | 8 weeks |
| Microbiome Change in Relative Proportion of Top 10 Genera From Baseline to 8 Weeks | A measure of how many of the top types of bacteria are present in the sputum or oral sample. Value changes with asthma | 8 weeks |
| Chicago |
| Illinois |
| 60637 |
| United States |
| BG002 | Non-asthmatic Controls | Non-asthmatic controls to assess variability of microbiome composition and diversity over time in a normal population. No intervention given. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Non-asthmatic Controls | Non-asthmatic controls to assess variability of microbiome composition and diversity over time in a normal population. No intervention given. |
|
|
|
| Secondary | Forced Expiratory Volume (FEV1) Change From Baseline Over 8 Weeks | Volume of air exhaled in 1 second on a forced expiration, expressed as percent of predicted, indicating the degree of airflow obstruction in asthma | Posted | Mean | Standard Error | percentage of predicted | 8 weeks |
|
|
|
|
| Secondary | Sputum Eosinophils Change From Baseline Over 8 Weeks | Percentage of 'eosinophils', an inflammatory cell seen in the airways of people with asthma, indicating the degree of inflammation | Some patients had missing data. | Posted | Mean | Full Range | percentage of eosinophils | Baseline and 8 weeks |
|
|
|
| Secondary | Sputum Neutrophils Change From Baseline Over 8 Weeks | Percentage of 'neutrophils', an inflammatory cell seen in the airways of people with asthma, indicating the degree of inflammation | Some patients had missing data. | Posted | Mean | Full Range | percentage of neutrophils | Baseline and 8 weeks |
|
|
|
| Secondary | Number of Participants With Diary Event or Serious Asthma Exacerbation Over 8 Weeks | The outcome is derived from a weighted scoring system called CompEx that describes asthma symptoms recorded on a daily basis. Final result is a dichotomous outcome indicating whether the patient had a "diary event" based on changes in peak expiratory flow, reliever use, and asthma symptoms or a serious exacerbation (deterioration of asthma leading to oral corticosteroid use, emergency room admission, or hospital admission). | Outcome measure is not applicable to non-asthmatic controls, as they were not assessed for asthma severity. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
|
| Secondary | Microbiome Shannon Alpha-diversity Score Change From Baseline to 8 Weeks | A measure of the diversity of the bacteria in the sputum or oral sample; that is, how many different types of bacteria are present. This value decreases in severe asthma | Insufficient sample size for meaningful results in intervention arms due to low accrual. Microbiome assays were not performed. | Posted | 8 weeks |
|
|
| Secondary | Microbiome Beta-diversity Score Change From Baseline to 8 Weeks | A second measure of the diversity of the bacteria in the sputum or oral sample; that is, how many different types of bacteria are present. This value decreases in severe asthma | Insufficient sample size for meaningful results in intervention arms. Microbiome assays were not performed. | Posted | 8 weeks |
|
|
| Secondary | Microbiome Change in Relative Proportion of Top 10 Genera From Baseline to 8 Weeks | A measure of how many of the top types of bacteria are present in the sputum or oral sample. Value changes with asthma | Insufficient sample size for meaningful results in intervention arms. Microbiome assays were not performed. | Posted | 8 weeks |
|
|
| 3 |
| 0 |
| 3 |
| 2 |
| 3 |
| EG001 | Azithromycin | 8 weeks of Azithromycin (250 mg) capsule once daily by mouth Azithromycin: 8 weeks of Azithromycin (250 mg) once daily by mouth | 0 | 2 | 0 | 2 | 2 | 2 |
| Wheezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Organic Chemicals |