Trial Outcomes & Findings for AZMATICS: AZithroMycin/Asthma Trial In Community Settings (NCT NCT00266851)
NCT ID: NCT00266851
Last Updated: 2019-09-06
Results Overview
5-point scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=worst ever, the lower scores indicate improvement in asthma symptoms
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
97 participants
Primary outcome timeframe
Within the past 24 hours; measured every 1.5 months for one year
Results posted on
2019-09-06
Participant Flow
Participant milestones
| Measure |
Placebo
Adjunctive placebo
Placebo: Matching placebo
|
Azithromycin
Active adjunctive treatment
Azithromycin: 600 mg x 3 days, then 600 mg weekly x 11 weeks
|
Observational Cohort
Eligible participants that declined randomization were offered enrollment in open-label, azithromycin treatment arm
|
|---|---|---|---|
|
Overall Study
STARTED
|
37
|
38
|
22
|
|
Overall Study
Completed 3 Month Follow up
|
26
|
22
|
15
|
|
Overall Study
Completed 6 Month Follow up
|
27
|
22
|
17
|
|
Overall Study
Completed 9 Month Follow up
|
22
|
23
|
15
|
|
Overall Study
Completed 12 Month Follow up
|
25
|
19
|
13
|
|
Overall Study
COMPLETED
|
37
|
38
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Not all participants were allergy tested, this was a physician decision
Baseline characteristics by cohort
| Measure |
Placebo
n=37 Participants
Adjunctive placebo
Placebo: Matching placebo
|
Azithromycin
n=38 Participants
Active adjunctive treatment
Azithromycin: 600 mg x 3 days, then 600 mg weekly x 11 weeks
|
Observational Cohort
n=22 Participants
Eligible participants who declined randomization were offered enrollment in an observational open-label azithromycin arm
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.4 years
STANDARD_DEVIATION 14.2 • n=37 Participants
|
45.7 years
STANDARD_DEVIATION 15.5 • n=38 Participants
|
45.4 years
STANDARD_DEVIATION 15.2 • n=22 Participants
|
46.3 years
STANDARD_DEVIATION 14.8 • n=97 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=37 Participants
|
27 Participants
n=38 Participants
|
10 Participants
n=22 Participants
|
61 Participants
n=97 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=37 Participants
|
11 Participants
n=38 Participants
|
12 Participants
n=22 Participants
|
36 Participants
n=97 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
33 Participants
n=37 Participants
|
36 Participants
n=38 Participants
|
18 Participants
n=22 Participants
|
87 Participants
n=97 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
4 Participants
n=37 Participants
|
2 Participants
n=38 Participants
|
4 Participants
n=22 Participants
|
10 Participants
n=97 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=37 Participants
|
38 participants
n=38 Participants
|
22 participants
n=22 Participants
|
97 participants
n=97 Participants
|
|
Smoking Status
Never
|
13 Participants
n=37 Participants
|
20 Participants
n=38 Participants
|
16 Participants
n=22 Participants
|
49 Participants
n=97 Participants
|
|
Smoking Status
Former
|
19 Participants
n=37 Participants
|
12 Participants
n=38 Participants
|
6 Participants
n=22 Participants
|
37 Participants
n=97 Participants
|
|
Smoking Status
Current
|
5 Participants
n=37 Participants
|
6 Participants
n=38 Participants
|
0 Participants
n=22 Participants
|
11 Participants
n=97 Participants
|
|
Education
|
15 years
n=37 Participants
|
14 years
n=38 Participants
|
17 years
n=22 Participants
|
15 years
n=97 Participants
|
|
Chronic Sinusitis
|
11 Participants
n=37 Participants
|
14 Participants
n=38 Participants
|
19 Participants
n=22 Participants
|
44 Participants
n=97 Participants
|
|
Allergy Tested
Negative
|
2 Participants
n=18 Participants • Not all participants were allergy tested, this was a physician decision
|
1 Participants
n=18 Participants • Not all participants were allergy tested, this was a physician decision
|
6 Participants
n=19 Participants • Not all participants were allergy tested, this was a physician decision
|
9 Participants
n=55 Participants • Not all participants were allergy tested, this was a physician decision
|
|
Allergy Tested
Positive for 1-3 positive
|
4 Participants
n=18 Participants • Not all participants were allergy tested, this was a physician decision
|
3 Participants
n=18 Participants • Not all participants were allergy tested, this was a physician decision
|
8 Participants
n=19 Participants • Not all participants were allergy tested, this was a physician decision
|
15 Participants
n=55 Participants • Not all participants were allergy tested, this was a physician decision
|
|
Allergy Tested
Positive for equal to or greater than 4
|
12 Participants
n=18 Participants • Not all participants were allergy tested, this was a physician decision
|
14 Participants
n=18 Participants • Not all participants were allergy tested, this was a physician decision
|
5 Participants
n=19 Participants • Not all participants were allergy tested, this was a physician decision
|
31 Participants
n=55 Participants • Not all participants were allergy tested, this was a physician decision
|
|
Infectious Asthma
|
6 Participants
n=37 Participants
|
17 Participants
n=38 Participants
|
13 Participants
n=22 Participants
|
36 Participants
n=97 Participants
|
|
Exacerbations
Hospitalized
|
0 Participants
n=37 Participants
|
2 Participants
n=38 Participants
|
4 Participants
n=22 Participants
|
6 Participants
n=97 Participants
|
|
Exacerbations
Emergency Visit
|
14 Participants
n=37 Participants
|
19 Participants
n=38 Participants
|
9 Participants
n=22 Participants
|
42 Participants
n=97 Participants
|
|
Exacerbations
Steroid burst
|
22 Participants
n=37 Participants
|
24 Participants
n=38 Participants
|
13 Participants
n=22 Participants
|
59 Participants
n=97 Participants
|
|
Baseline Asthma Severity
Day Symptom Frequency · Mild to Moderate
|
35 Participants
n=37 Participants
|
34 Participants
n=38 Participants
|
15 Participants
n=22 Participants
|
84 Participants
n=97 Participants
|
|
Baseline Asthma Severity
Day Symptom Frequency · Severe
|
2 Participants
n=37 Participants
|
4 Participants
n=38 Participants
|
7 Participants
n=22 Participants
|
13 Participants
n=97 Participants
|
|
Baseline Asthma Severity
Night Symptom Frequency · Mild to Moderate
|
33 Participants
n=37 Participants
|
33 Participants
n=38 Participants
|
15 Participants
n=22 Participants
|
81 Participants
n=97 Participants
|
|
Baseline Asthma Severity
Night Symptom Frequency · Severe
|
4 Participants
n=37 Participants
|
5 Participants
n=38 Participants
|
7 Participants
n=22 Participants
|
16 Participants
n=97 Participants
|
|
Coexisting COPD
|
8 Participants
n=37 Participants
|
5 Participants
n=38 Participants
|
2 Participants
n=22 Participants
|
15 Participants
n=97 Participants
|
|
Lung Function, FEV
|
2.35 liters in one second
STANDARD_DEVIATION 1.31 • n=19 Participants • data was unable to be collected from all participants
|
2.33 liters in one second
STANDARD_DEVIATION 1.05 • n=19 Participants • data was unable to be collected from all participants
|
2.48 liters in one second
STANDARD_DEVIATION 1.19 • n=7 Participants • data was unable to be collected from all participants
|
2.36 liters in one second
STANDARD_DEVIATION 1.16 • n=45 Participants • data was unable to be collected from all participants
|
|
Lung Function, PEFR
|
251 liters per min
STANDARD_DEVIATION 105 • n=24 Participants • data was unable to be collected from all participants
|
273 liters per min
STANDARD_DEVIATION 109 • n=26 Participants • data was unable to be collected from all participants
|
300 liters per min
STANDARD_DEVIATION 105 • n=18 Participants • data was unable to be collected from all participants
|
272 liters per min
STANDARD_DEVIATION 107 • n=68 Participants • data was unable to be collected from all participants
|
|
Controller Medication
Inhaled Corticosteroid
|
30 Participants
n=37 Participants
|
24 Participants
n=38 Participants
|
18 Participants
n=22 Participants
|
72 Participants
n=97 Participants
|
|
Controller Medication
Long-Acting Bronchodilator
|
26 Participants
n=37 Participants
|
14 Participants
n=38 Participants
|
15 Participants
n=22 Participants
|
55 Participants
n=97 Participants
|
|
Controller Medication
Leukotriene Inhibitor
|
8 Participants
n=37 Participants
|
9 Participants
n=38 Participants
|
6 Participants
n=22 Participants
|
23 Participants
n=97 Participants
|
|
Controller Medication
Oral Prednisone
|
4 Participants
n=37 Participants
|
2 Participants
n=38 Participants
|
1 Participants
n=22 Participants
|
7 Participants
n=97 Participants
|
|
Baseline Asthma Measures
Overall Asthma Symptoms
|
1.48 scores on a scale
STANDARD_DEVIATION 0.94 • n=37 Participants
|
1.42 scores on a scale
STANDARD_DEVIATION 0.77 • n=38 Participants
|
2.06 scores on a scale
STANDARD_DEVIATION 0.73 • n=22 Participants
|
1.57 scores on a scale
STANDARD_DEVIATION 0.86 • n=97 Participants
|
|
Baseline Asthma Measures
Asthma Quality of Life
|
4.97 scores on a scale
STANDARD_DEVIATION 1.28 • n=37 Participants
|
4.98 scores on a scale
STANDARD_DEVIATION 1.27 • n=38 Participants
|
4.12 scores on a scale
STANDARD_DEVIATION 1.29 • n=22 Participants
|
4.79 scores on a scale
STANDARD_DEVIATION 1.31 • n=97 Participants
|
|
Baseline Asthma Measures
Asthma Control
|
1.56 scores on a scale
STANDARD_DEVIATION 1.02 • n=37 Participants
|
1.75 scores on a scale
STANDARD_DEVIATION 0.93 • n=38 Participants
|
2.26 scores on a scale
STANDARD_DEVIATION 1.35 • n=22 Participants
|
1.78 scores on a scale
STANDARD_DEVIATION 1.08 • n=97 Participants
|
|
Participant Age at Asthma Diagnosis
|
24 years
n=37 Participants
|
24 years
n=38 Participants
|
28 years
n=22 Participants
|
25 years
n=97 Participants
|
PRIMARY outcome
Timeframe: Within the past 24 hours; measured every 1.5 months for one yearPopulation: All participants did not adhere to follow-up schedule
5-point scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=worst ever, the lower scores indicate improvement in asthma symptoms
Outcome measures
| Measure |
Placebo
n=37 Participants
Adjunctive placebo
Placebo: Matching placebo
|
Azithromycin
n=38 Participants
Active adjunctive treatment
Azithromycin: 600 mg x 3 days, then 600 mg weekly x 11 weeks
|
Observational Cohort
n=22 Participants
Eligible Participants who declined randomization were offered enrollment in a parallel open-label observational treatment arm
|
|---|---|---|---|
|
Change in Overall Asthma Symptoms From Baseline
Change from Baseline to Week 36
|
-0.21 units on a scale
Standard Deviation 1.14
|
-0.22 units on a scale
Standard Deviation 0.70
|
-1.27 units on a scale
Standard Deviation 0.70
|
|
Change in Overall Asthma Symptoms From Baseline
Change from Baseline to Week 6
|
-0.60 units on a scale
Standard Deviation 1.07
|
-0.15 units on a scale
Standard Deviation 0.83
|
-0.88 units on a scale
Standard Deviation 0.81
|
|
Change in Overall Asthma Symptoms From Baseline
Change from Baseline to Week 12
|
-0.48 units on a scale
Standard Deviation 1.16
|
-0.31 units on a scale
Standard Deviation 0.74
|
-1.0 units on a scale
Standard Deviation 1.37
|
|
Change in Overall Asthma Symptoms From Baseline
Change from Baseline to Week 18
|
-0.15 units on a scale
Standard Deviation 1.13
|
0.10 units on a scale
Standard Deviation 0.75
|
-0.94 units on a scale
Standard Deviation 1.12
|
|
Change in Overall Asthma Symptoms From Baseline
Change from Baseline to Week 24
|
-0.08 units on a scale
Standard Deviation 0.95
|
-0.10 units on a scale
Standard Deviation 0.96
|
-1.0 units on a scale
Standard Deviation 1.17
|
|
Change in Overall Asthma Symptoms From Baseline
Change from Baseline to Week 30
|
-0.05 units on a scale
Standard Deviation 1.09
|
-0.34 units on a scale
Standard Deviation 1.01
|
-0.81 units on a scale
Standard Deviation 1.17
|
|
Change in Overall Asthma Symptoms From Baseline
Change from Baseline to Week 42
|
-0.04 units on a scale
Standard Deviation 0.88
|
-0.12 units on a scale
Standard Deviation 0.93
|
-1.21 units on a scale
Standard Deviation 0.70
|
|
Change in Overall Asthma Symptoms From Baseline
Change from Baseline to Week 48
|
-0.10 units on a scale
Standard Deviation 1.07
|
-0.07 units on a scale
Standard Deviation 0.88
|
-1.07 units on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Within the past week; every 3 monthsPopulation: All participants did not adhere to follow-up schedule
Mini-Juniper Asthma Control Questionnaire without pulmonary function. This is a 6-item survey scored on a 7 point scale where 0 is none, or no symptoms and 6 is severe or symptoms all of the time. Answers are averaged for a final score of 0-6. Data are reported as a change from baseline.
Outcome measures
| Measure |
Placebo
n=37 Participants
Adjunctive placebo
Placebo: Matching placebo
|
Azithromycin
n=38 Participants
Active adjunctive treatment
Azithromycin: 600 mg x 3 days, then 600 mg weekly x 11 weeks
|
Observational Cohort
n=22 Participants
Eligible Participants who declined randomization were offered enrollment in a parallel open-label observational treatment arm
|
|---|---|---|---|
|
Change in Asthma Control Over Baseline
Change from Baseline to Week 6
|
-0.37 scores on a scale
Standard Deviation 0.88
|
-0.46 scores on a scale
Standard Deviation 0.60
|
-1.24 scores on a scale
Standard Deviation 1.14
|
|
Change in Asthma Control Over Baseline
Change from Baseline to Week 12
|
-0.41 scores on a scale
Standard Deviation 1.01
|
-0.40 scores on a scale
Standard Deviation 0.80
|
-1.38 scores on a scale
Standard Deviation 1.87
|
|
Change in Asthma Control Over Baseline
Change from Baseline to Week 18
|
-0.40 scores on a scale
Standard Deviation 1.05
|
-0.28 scores on a scale
Standard Deviation 0.88
|
-1.18 scores on a scale
Standard Deviation 1.53
|
|
Change in Asthma Control Over Baseline
Change from Baseline to Week 24
|
-0.37 scores on a scale
Standard Deviation 1.12
|
-0.34 scores on a scale
Standard Deviation 1.03
|
-1.35 scores on a scale
Standard Deviation 1.69
|
|
Change in Asthma Control Over Baseline
Change from Baseline to Week 30
|
-0.25 scores on a scale
Standard Deviation 1.22
|
-0.56 scores on a scale
Standard Deviation 0.81
|
-1.04 scores on a scale
Standard Deviation 1.38
|
|
Change in Asthma Control Over Baseline
Change from Baseline to Week 36
|
-0.39 scores on a scale
Standard Deviation 1.00
|
-0.39 scores on a scale
Standard Deviation 0.79
|
-1.63 scores on a scale
Standard Deviation 1.41
|
|
Change in Asthma Control Over Baseline
Change from Baseline to Week 42
|
-0.22 scores on a scale
Standard Deviation 1.32
|
-0.38 scores on a scale
Standard Deviation 0.72
|
-1.42 scores on a scale
Standard Deviation 1.41
|
|
Change in Asthma Control Over Baseline
Change from Baseline to Week 48
|
-0.45 scores on a scale
Standard Deviation 1.00
|
-0.34 scores on a scale
Standard Deviation 0.88
|
-1.08 scores on a scale
Standard Deviation 1.20
|
SECONDARY outcome
Timeframe: Within the past 2 weeks; every three monthsPopulation: All participants did not adhere to follow-up schedule
Juniper Asthma Quality of Life Questionnaire is a 32-item survey, recall of the past 2 weeks, scored on a 7 point Likert scale where 1 is severely impaired, and 7 is not impaired at all. Scores are averaged for a final range of 1-7. Change from Baseline is reported here.
Outcome measures
| Measure |
Placebo
n=37 Participants
Adjunctive placebo
Placebo: Matching placebo
|
Azithromycin
n=38 Participants
Active adjunctive treatment
Azithromycin: 600 mg x 3 days, then 600 mg weekly x 11 weeks
|
Observational Cohort
n=22 Participants
Eligible Participants who declined randomization were offered enrollment in a parallel open-label observational treatment arm
|
|---|---|---|---|
|
Change is Asthma-specific Quality-of-Life (AQL)
Change from Baseline to Week 12
|
0.50 score on a scale
Standard Deviation 0.95
|
0.67 score on a scale
Standard Deviation 1.10
|
1.54 score on a scale
Standard Deviation 1.91
|
|
Change is Asthma-specific Quality-of-Life (AQL)
Change from Baseline to Week 24
|
0.31 score on a scale
Standard Deviation 1.36
|
0.49 score on a scale
Standard Deviation 1.11
|
1.36 score on a scale
Standard Deviation 1.75
|
|
Change is Asthma-specific Quality-of-Life (AQL)
Change from Baseline to Week 36
|
0.23 score on a scale
Standard Deviation 1.02
|
0.58 score on a scale
Standard Deviation 1.04
|
2.05 score on a scale
Standard Deviation 1.40
|
|
Change is Asthma-specific Quality-of-Life (AQL)
Change from Baseline to Week 48
|
0.40 score on a scale
Standard Deviation 1.33
|
0.50 score on a scale
Standard Deviation 1.10
|
1.70 score on a scale
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: This study was not powered to detect significant differences in exacerbation frequency.
A steroid burst, an unscheduled or emergency visit and/or a hospitalization for asthma, reported at Weeks 0, 6, 12, 18, 24, 30, 36, 42, 48, and any time during follow up.
Outcome measures
| Measure |
Placebo
n=37 Participants
Adjunctive placebo
Placebo: Matching placebo
|
Azithromycin
n=38 Participants
Active adjunctive treatment
Azithromycin: 600 mg x 3 days, then 600 mg weekly x 11 weeks
|
Observational Cohort
n=22 Participants
Eligible Participants who declined randomization were offered enrollment in a parallel open-label observational treatment arm
|
|---|---|---|---|
|
Asthma Exacerbations
Week 0
|
9 Participants
|
9 Participants
|
6 Participants
|
|
Asthma Exacerbations
Week 6
|
9 Participants
|
6 Participants
|
3 Participants
|
|
Asthma Exacerbations
Week 12
|
3 Participants
|
6 Participants
|
4 Participants
|
|
Asthma Exacerbations
Week 18
|
5 Participants
|
6 Participants
|
3 Participants
|
|
Asthma Exacerbations
Week 24
|
6 Participants
|
4 Participants
|
5 Participants
|
|
Asthma Exacerbations
Week 30
|
4 Participants
|
6 Participants
|
6 Participants
|
|
Asthma Exacerbations
Week 36
|
5 Participants
|
7 Participants
|
2 Participants
|
|
Asthma Exacerbations
Week 48
|
5 Participants
|
7 Participants
|
2 Participants
|
|
Asthma Exacerbations
At any time during follow up
|
15 Participants
|
20 Participants
|
10 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Azithromycin
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Observational Cohort
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=34 participants at risk；n=37 participants at risk
Adjunctive placebo
Placebo: Matching placebo
|
Azithromycin
n=35 participants at risk；n=38 participants at risk
Active adjunctive treatment
Azithromycin: 600 mg x 3 days, then 600 mg weekly x 11 weeks
|
Observational Cohort
n=20 participants at risk；n=22 participants at risk
Eligible participants who refused randomization were offered enrollment in an open-label azithromycin arm
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
2.7%
1/37 • up to 12 weeks
|
0.00%
0/38 • up to 12 weeks
|
0.00%
0/22 • up to 12 weeks
|
Other adverse events
| Measure |
Placebo
n=34 participants at risk；n=37 participants at risk
Adjunctive placebo
Placebo: Matching placebo
|
Azithromycin
n=35 participants at risk；n=38 participants at risk
Active adjunctive treatment
Azithromycin: 600 mg x 3 days, then 600 mg weekly x 11 weeks
|
Observational Cohort
n=20 participants at risk；n=22 participants at risk
Eligible participants who refused randomization were offered enrollment in an open-label azithromycin arm
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.8%
3/34 • up to 12 weeks
|
28.6%
10/35 • up to 12 weeks
|
40.0%
8/20 • up to 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
2/34 • up to 12 weeks
|
5.7%
2/35 • up to 12 weeks
|
10.0%
2/20 • up to 12 weeks
|
|
General disorders
Stomach Pain
|
11.8%
4/34 • up to 12 weeks
|
31.4%
11/35 • up to 12 weeks
|
55.0%
11/20 • up to 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
14.7%
5/34 • up to 12 weeks
|
34.3%
12/35 • up to 12 weeks
|
55.0%
11/20 • up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
1/34 • up to 12 weeks
|
8.6%
3/35 • up to 12 weeks
|
20.0%
4/20 • up to 12 weeks
|
|
General disorders
Swelling
|
0.00%
0/34 • up to 12 weeks
|
5.7%
2/35 • up to 12 weeks
|
10.0%
2/20 • up to 12 weeks
|
|
Ear and labyrinth disorders
Hearing Loss
|
5.9%
2/34 • up to 12 weeks
|
2.9%
1/35 • up to 12 weeks
|
5.0%
1/20 • up to 12 weeks
|
|
Reproductive system and breast disorders
Vaginal Candidasis
|
8.8%
3/34 • up to 12 weeks
|
11.4%
4/35 • up to 12 weeks
|
5.0%
1/20 • up to 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place