Trial Outcomes & Findings for Childhood Asthma Research and Education (CARE) Network Trial - Best Add-On Therapy Giving Effective Response (BADGER) (NCT NCT00395304)

NCT ID: NCT00395304

Last Updated: 2018-07-02

Results Overview

One treatment period was ranked as better than another if the total amount of prednisone received during the period was at least 180 mg less, if the number of annualized asthma-control days during the final 12 weeks of the period was increased by at least 31 days, or if the FEV1 at the end of the period was at least 5% higher. If the prednisone threshold was met, then we ignored the number of asthmacontrol days and the FEV1. If the threshold for asthma-control days was met, then we ignored the FEV1. Otherwise, the order of response was determined by the FEV1.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 182 participants
• Primary outcome timeframe: Measured during the last 12 weeks of each 16-week treatment period
• Results posted on: 2018-07-02

Participant Flow

Participant milestones

Measure	2xICS, 1xICS + LABA, 1xICS + LTRA Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)	2xICS, 1xICS + LTRA, 1xICS + LABA Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)	1xICS +LABA, 2xICS, 1xICS + LTRA Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)	1xICS + LABA, 1xICS + LTRA, 2xICS Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)	1xICS + LTRA, 2xICS, 1xICS + LABA Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)	1xICS + LTRA, 1xICS + LABA, 2xICS Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
Treatment Period 1 STARTED	31	30	30	31	28	32
Treatment Period 1 COMPLETED	30	26	30	28	27	30
Treatment Period 1 NOT COMPLETED	1	4	0	3	1	2
Treatment Period 2 STARTED	30	26	30	28	27	30
Treatment Period 2 COMPLETED	30	22	29	27	27	28
Treatment Period 2 NOT COMPLETED	0	4	1	1	0	2
Treatment Period 3 STARTED	30	22	29	27	27	28
Treatment Period 3 COMPLETED	29	20	29	25	27	27
Treatment Period 3 NOT COMPLETED	1	2	0	2	0	1

Reasons for withdrawal

Measure	2xICS, 1xICS + LABA, 1xICS + LTRA Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)	2xICS, 1xICS + LTRA, 1xICS + LABA Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)	1xICS +LABA, 2xICS, 1xICS + LTRA Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)	1xICS + LABA, 1xICS + LTRA, 2xICS Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)	1xICS + LTRA, 2xICS, 1xICS + LABA Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)	1xICS + LTRA, 1xICS + LABA, 2xICS Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
Treatment Period 1 Withdrawal by Subject	0	3	0	2	1	1
Treatment Period 1 Lost to Follow-up	1	0	0	1	0	1
Treatment Period 1 Physician Decision	0	1	0	0	0	0
Treatment Period 2 Withdrawal by Subject	0	0	0	1	0	2
Treatment Period 2 Lost to Follow-up	0	3	0	0	0	0
Treatment Period 2 Physician Decision	0	0	1	0	0	0
Treatment Period 2 Other	0	1	0	0	0	0
Treatment Period 3 Withdrawal by Subject	0	0	0	1	0	1
Treatment Period 3 Lost to Follow-up	1	1	0	0	0	0
Treatment Period 3 Physician Decision	0	1	0	0	0	0
Treatment Period 3 Other	0	0	0	1	0	0

Baseline Characteristics

Childhood Asthma Research and Education (CARE) Network Trial - Best Add-On Therapy Giving Effective Response (BADGER)

Baseline characteristics by cohort

Measure	All Participants n=182 Participants All participants randomized to the six crossover sequences
Age, Categorical <=18 years	182 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	10.8 years STANDARD_DEVIATION 2.7 • n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants
Sex: Female, Male Male	119 Participants n=5 Participants
Region of Enrollment United States	182 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Population: ITT. Although only 157 participants completed all three treatment periods, there was sufficient data on 8 additional participants to include them in the analysis of the primary outcome.

One treatment period was ranked as better than another if the total amount of prednisone received during the period was at least 180 mg less, if the number of annualized asthma-control days during the final 12 weeks of the period was increased by at least 31 days, or if the FEV1 at the end of the period was at least 5% higher. If the prednisone threshold was met, then we ignored the number of asthmacontrol days and the FEV1. If the threshold for asthma-control days was met, then we ignored the FEV1. Otherwise, the order of response was determined by the FEV1.

Outcome measures

Measure	All Participants n=165 Participants All participants randomized to the six crossover sequences	1xICS + LABA Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)	1xICS + LTRA Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1.	161 Participants	—	—

SECONDARY outcome

Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Population: Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design

Outcome measures

Measure	All Participants n=161 Participants All participants randomized to the six crossover sequences	1xICS + LABA n=160 Participants Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)	1xICS + LTRA n=155 Participants Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
Change From Baseline in the Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) % Predicted	0.26 percentage points Standard Deviation 11.02	1.07 percentage points Standard Deviation 9.45	-0.84 percentage points Standard Deviation 10.25

SECONDARY outcome

Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Population: Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design

Outcome measures

Measure	All Participants n=157 Participants All participants randomized to the six crossover sequences	1xICS + LABA n=152 Participants Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)	1xICS + LTRA n=153 Participants Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
Change From Baseline in the Post-bronchodilator FEV1 Percent Predicted	-0.2 percentage points Standard Deviation 9.7	-1.2 percentage points Standard Deviation 8.9	-0.8 percentage points Standard Deviation 10.1

SECONDARY outcome

Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Population: Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design

Outcome measures

Measure	All Participants n=161 Participants All participants randomized to the six crossover sequences	1xICS + LABA n=160 Participants Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)	1xICS + LTRA n=155 Participants Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
Change From Baseline in the Pre-bronchodilator Forced Vital Capacity (FVC) % Predicted	-1.00 percentage points Standard Deviation 10.18	-1.58 percentage points Standard Deviation 8.04	-1.56 percentage points Standard Deviation 8.63

SECONDARY outcome

Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Population: Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design

Outcome measures

Measure	All Participants n=161 Participants All participants randomized to the six crossover sequences	1xICS + LABA n=160 Participants Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)	1xICS + LTRA n=155 Participants Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
Change From Baseline in the Pre-bronchodilator FEV1/FVC Ratio	0.98 ratio Standard Deviation 4.60	2.13 ratio Standard Deviation 4.75	0.55 ratio Standard Deviation 5.11

SECONDARY outcome

Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Population: Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design

Outcome measures

Measure	All Participants n=159 Participants All participants randomized to the six crossover sequences	1xICS + LABA n=161 Participants Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)	1xICS + LTRA n=155 Participants Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
Change From Baseline in the Morning Peak Expiratory Flow Rate (PEFR) % Predicted	4.44 percentage points Standard Deviation 11.25	6.26 percentage points Standard Deviation 9.91	4.04 percentage points Standard Deviation 9.66

SECONDARY outcome

Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Population: Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design

Outcome measures

Measure	All Participants n=159 Participants All participants randomized to the six crossover sequences	1xICS + LABA n=161 Participants Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)	1xICS + LTRA n=155 Participants Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
Change From Baseline in the Evening Peak Expiratory Flow Rate (PEFR) % Predicted	2.84 percentage points Standard Deviation 10.17	4.87 percentage points Standard Deviation 9.20	2.29 percentage points Standard Deviation 8.73

SECONDARY outcome

Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Population: Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design

PEFR variability is calculated as 100% times the difference between the evening and morning PEFR values, divided by the average of the evening and morning PEFR values, i.e., PEFR variability = 100% x (morning PEFR - evening PEFR)/((morning PEFR + evening PEFR)/2)

Outcome measures

Measure	All Participants n=154 Participants All participants randomized to the six crossover sequences	1xICS + LABA n=156 Participants Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)	1xICS + LTRA n=150 Participants Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
Change From Baseline in the Peak Expiratory Flow Rate (PEFR) Variability	2.09 percentage points Standard Deviation 7.37	1.61 percentage points Standard Deviation 6.83	1.72 percentage points Standard Deviation 6.68

SECONDARY outcome

Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Population: Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design

Change from baseline in the impulse oscillometry resistance at 5 Hertz, measured in kiloPascals per liters per second

Outcome measures

Measure	All Participants n=165 Participants All participants randomized to the six crossover sequences	1xICS + LABA n=163 Participants Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)	1xICS + LTRA n=161 Participants Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
Change From Baseline in the Impulse Oscillometry Resistance at 5 Hertz	-0.08 kiloPascals per liters per second Standard Deviation 0.15	-0.09 kiloPascals per liters per second Standard Deviation 0.13	-0.06 kiloPascals per liters per second Standard Deviation 0.14

SECONDARY outcome

Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Population: Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design

The methacholine PC20 is the concentration of methacholine that causes a 20% decrease in the pre-bronchodilator FEV1. The logarithm base 2 transformation converts the PC20 into doubling dilutions.

Outcome measures

Measure	All Participants n=111 Participants All participants randomized to the six crossover sequences	1xICS + LABA n=112 Participants Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)	1xICS + LTRA n=94 Participants Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
Change From Baseline in the Logarithm Base 2 of the Methacholine PC20	1.11 doubling dilutions Standard Deviation 2.14	1.20 doubling dilutions Standard Deviation 2.31	1.00 doubling dilutions Standard Deviation 2.16

SECONDARY outcome

Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Population: Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design

Outcome measures

Measure	All Participants n=151 Participants All participants randomized to the six crossover sequences	1xICS + LABA n=150 Participants Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)	1xICS + LTRA n=150 Participants Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
Change From Baseline in the Natural Logarithm of Exhaled Nitric Oxide (eNO)	-0.04 natural logarithm of parts per billion Standard Deviation 0.68	-0.05 natural logarithm of parts per billion Standard Deviation 0.74	-0.02 natural logarithm of parts per billion Standard Deviation 0.71

SECONDARY outcome

Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Population: Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design

The ACT consists of five items, each scored as 1 (worst) to 5 (best). The five items are averaged.

Outcome measures

Measure	All Participants n=164 Participants All participants randomized to the six crossover sequences	1xICS + LABA n=162 Participants Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)	1xICS + LTRA n=159 Participants Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
Change From Baseline in the Asthma Control Test (ACT)	1.49 units on a scale Standard Deviation 4.09	1.87 units on a scale Standard Deviation 4.12	1.69 units on a scale Standard Deviation 4.00

SECONDARY outcome

Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Population: Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design

Asthma quality of life is measured as the average of 23 questions, each of which is scored from 1 (worse) to 7 (best)

Outcome measures

Measure	All Participants n=165 Participants All participants randomized to the six crossover sequences	1xICS + LABA n=161 Participants Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)	1xICS + LTRA n=160 Participants Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
Change From Baseline in Asthma Quality of Life	0.2 units on a scale Standard Deviation 0.1	0.3 units on a scale Standard Deviation 0.9	0.3 units on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Population: Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design

An asthma exacerbation was defined as the administration of a course of oral/systemic prednisone for the treatment of asthma.

Outcome measures

Measure	All Participants n=165 Participants All participants randomized to the six crossover sequences	1xICS + LABA n=163 Participants Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)	1xICS + LTRA n=161 Participants Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
Number of Participants With Asthma Exacerbations	49 Participants	35 Participants	37 Participants

Adverse Events

All Participants

Serious events: 7 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Participants n=182 participants at risk All participants randomized to the six crossover sequences
Respiratory, thoracic and mediastinal disorders asthma exacerbation requirung hospitalization	1.6% 3/182 • Number of events 3 • 1 year does not differ from the clinicaltrials.gov definitions
Gastrointestinal disorders appendicitis	0.55% 1/182 • Number of events 1 • 1 year does not differ from the clinicaltrials.gov definitions
Blood and lymphatic system disorders tonsillectomy	1.1% 2/182 • Number of events 2 • 1 year does not differ from the clinicaltrials.gov definitions
Psychiatric disorders behavioral problems	0.55% 1/182 • Number of events 1 • 1 year does not differ from the clinicaltrials.gov definitions

Other adverse events

Measure	All Participants n=182 participants at risk All participants randomized to the six crossover sequences
Respiratory, thoracic and mediastinal disorders asthma exacerbation not requiring hospitalization	12.1% 22/182 • Number of events 22 • 1 year does not differ from the clinicaltrials.gov definitions

Additional Information

Vernon M. Chinchilli

Penn State Hershey College of Medicine

Phone: 717-531-4262

Email: vchinchi@psu.edu

Results disclosure agreements

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