Trial Outcomes & Findings for Airway Microbiome in Asthma: Relationships to Asthma Phenotype and Inhaled Corticosteroid Treatment (NCT NCT01537133)

NCT ID: NCT01537133

Last Updated: 2016-11-30

Results Overview

Richness is the total number of different bacterial taxa detected in the sample.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 84 participants
• Primary outcome timeframe: baseline and after 6 weeks of treatment
• Results posted on: 2016-11-30

Participant Flow

Healthy controls and non-atopic asthmatics assessed only at baseline.

Participant milestones

Measure	Inhaled Corticosteroid Fluticasone (250 mcg/puff, one puff, twice a day)	Placebo Placebo fluticasone (one puff, twice a day)	Healthy Control	Atopic Non-asthmatics
Overall Study STARTED	28	14	21	21
Overall Study COMPLETED	25	14	21	21
Overall Study NOT COMPLETED	3	0	0	0

Reasons for withdrawal

Measure	Inhaled Corticosteroid Fluticasone (250 mcg/puff, one puff, twice a day)	Placebo Placebo fluticasone (one puff, twice a day)	Healthy Control	Atopic Non-asthmatics
Overall Study Withdrawal by Subject	2	0	0	0
Overall Study Lost to Follow-up	1	0	0	0

Baseline Characteristics

Airway Microbiome in Asthma: Relationships to Asthma Phenotype and Inhaled Corticosteroid Treatment

Baseline characteristics by cohort

Measure	Atopic Asthmatics Treated With Inhaled Corticosteroid n=28 Participants Fluticasone (250 mcg/puff, one puff, twice a day)	Atopic Asthmatics Treated With Placebo n=14 Participants Placebo fluticasone (one puff, twice a day)	Atopic Non-asthmatics n=21 Participants	Healthy Control n=21 Participants	Total n=84 Participants Total of all reporting groups
Age, Continuous	30 years n=5 Participants	37 years n=7 Participants	28 years n=5 Participants	28 years n=4 Participants	30 years n=21 Participants
Gender Female	16 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants	12 Participants n=4 Participants	46 Participants n=21 Participants
Gender Male	12 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	9 Participants n=4 Participants	38 Participants n=21 Participants
Race/Ethnicity, Customized White	16 participants n=5 Participants	9 participants n=7 Participants	11 participants n=5 Participants	15 participants n=4 Participants	51 participants n=21 Participants
Race/Ethnicity, Customized Black	7 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants	3 participants n=4 Participants	19 participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latio	3 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants	5 participants n=21 Participants
Race/Ethnicity, Customized Other	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants	1 participants n=4 Participants	9 participants n=21 Participants
Forced Expiratory Volume in 1 second	94 percent of predicted n=5 Participants	84 percent of predicted n=7 Participants	98 percent of predicted n=5 Participants	100 percent of predicted n=4 Participants	96 percent of predicted n=21 Participants
Blood Eosinophils	3.3 percent of cells in blood sample n=5 Participants	3.6 percent of cells in blood sample n=7 Participants	2.0 percent of cells in blood sample n=5 Participants	1.4 percent of cells in blood sample n=4 Participants	2.0 percent of cells in blood sample n=21 Participants
Sputum eosinophils	0.3 percent of cells in sputum sample n=5 Participants	0.7 percent of cells in sputum sample n=7 Participants	0 percent of cells in sputum sample n=5 Participants	0 percent of cells in sputum sample n=4 Participants	0.2 percent of cells in sputum sample n=21 Participants

PRIMARY outcome

Timeframe: baseline and after 6 weeks of treatment

Population: 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.

Richness is the total number of different bacterial taxa detected in the sample.

Outcome measures

Measure	Atopic Asthmatics Treated With Inhaled Corticosteroids n=16 Participants	Atopic Asthmatics Treated With Placebo n=12 Participants	Atopic Non-asthmatics n=15 Participants	Healthy Control n=13 Participants
Microbial Community Richness baseline	449 number of bacterial taxa Interval 376.0 to 613.0	543 number of bacterial taxa Interval 484.0 to 684.0	483 number of bacterial taxa Interval 437.0 to 646.0	444 number of bacterial taxa Interval 400.0 to 530.0
Microbial Community Richness after 6 weeks of treatment	456 number of bacterial taxa Interval 351.0 to 578.0	405 number of bacterial taxa Interval 385.0 to 714.0	NA number of bacterial taxa Only baseline data was collected from atopic non-asthmatics and healthy controls	NA number of bacterial taxa Only baseline data was collected from atopic non-asthmatics and healthy controls

PRIMARY outcome

Timeframe: baseline and after 6 weeks of treatment

Population: 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.

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).

Outcome measures

Measure	Atopic Asthmatics Treated With Inhaled Corticosteroids n=16 Participants	Atopic Asthmatics Treated With Placebo n=12 Participants	Atopic Non-asthmatics n=15 Participants	Healthy Control n=13 Participants
Microbial Community Diversity baseline	5.4 Shannon Diversity Index Interval 4.9 to 5.6	5.7 Shannon Diversity Index Interval 5.0 to 6.0	5.6 Shannon Diversity Index Interval 5.2 to 6.0	5.3 Shannon Diversity Index Interval 5.2 to 5.5
Microbial Community Diversity after 6 weeks of treatment	5.0 Shannon Diversity Index Interval 4.6 to 5.7	5.1 Shannon Diversity Index Interval 4.8 to 5.7	NA Shannon Diversity Index Only baseline data was collected from atopic non-asthmatics and healthy controls	NA Shannon Diversity Index Only baseline data was collected from atopic non-asthmatics and healthy controls

PRIMARY outcome

Timeframe: baseline and after 6 weeks of treatment

Population: 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.

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.

Outcome measures

Measure	Atopic Asthmatics Treated With Inhaled Corticosteroids n=16 Participants	Atopic Asthmatics Treated With Placebo n=12 Participants	Atopic Non-asthmatics n=15 Participants	Healthy Control n=13 Participants
Microbial Community Evenness baseline	0.88 Pielou's evenness index Interval 0.81 to 0.9	0.88 Pielou's evenness index Interval 0.79 to 0.91	0.90 Pielou's evenness index Interval 0.83 to 0.94	0.86 Pielou's evenness index Interval 0.83 to 0.91
Microbial Community Evenness after 6 weeks of treatment	0.85 Pielou's evenness index Interval 0.76 to 0.9	0.86 Pielou's evenness index Interval 0.81 to 0.88	NA Pielou's evenness index Only baseline data was collected from atopic non-asthmatics and healthy controls	NA Pielou's evenness index Only baseline data was collected from atopic non-asthmatics and healthy controls

Adverse Events

Inhaled Corticosteroid

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Inhaled Corticosteroid n=28 participants at risk Fluticasone (250 mcg/puff, one puff, twice a day)	Placebo n=14 participants at risk Placebo fluticasone (one puff, twice a day)
Respiratory, thoracic and mediastinal disorders Acute nasopharyngitis	7.1% 2/28 • Number of events 3 Adverse events were not collected or assessed for healthy controls or atopic non-asthmatics	14.3% 2/14 • Number of events 2 Adverse events were not collected or assessed for healthy controls or atopic non-asthmatics

Additional Information

David Mauger

Penn State University

Phone: 717-531-7178

Email: dtm5@psu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place