Trial Outcomes & Findings for AZISAST Study: AZIthromycin in Severe ASThma Study (NCT NCT00760838)
NCT ID: NCT00760838
Last Updated: 2014-06-26
Results Overview
Severe asthma exacerbations are defined as severe asthma episodes for which a treatment with antibiotics or cortisone is administered for a minimum of 3 days.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
109 participants
Primary outcome timeframe
from baseline to week 26
Results posted on
2014-06-26
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo
1x/day during 5 days 3x/week afterwards
|
Azithromycin
Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
55
|
|
Overall Study
COMPLETED
|
49
|
53
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Placebo
1x/day during 5 days 3x/week afterwards
|
Azithromycin
Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
AZISAST Study: AZIthromycin in Severe ASThma Study
Baseline characteristics by cohort
| Measure |
Placebo
n=54 Participants
Placebo
1x/day during 5 days 3x/week afterwards
|
Azithromycin
n=55 Participants
Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
53 years
n=5 Participants
|
53 years
n=7 Participants
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
54 participants
n=5 Participants
|
55 participants
n=7 Participants
|
109 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from baseline to week 26Population: intention to treat analysis
Severe asthma exacerbations are defined as severe asthma episodes for which a treatment with antibiotics or cortisone is administered for a minimum of 3 days.
Outcome measures
| Measure |
Placebo
n=54 Participants
Placebo
1x/day during 5 days 3x/week afterwards
|
Azithromycin
n=55 Participants
Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards
|
|---|---|---|
|
Proportion of Participants With Severe Asthma Exacerbations
|
0.52 proportion of participants
Interval 0.36 to 0.75
|
0.55 proportion of participants
Interval 0.38 to 0.78
|
SECONDARY outcome
Timeframe: from baseline to week 26Population: intention to treat analysis
proportion of participants using rescue medication is defined as the the number of participants who had to use rescue medication from baseline untill week 26, independent on the number of times the medication had to be used. This measure was conducted by averaging the proportion of participants using rescue medication from each week between baseline and week 26.
Outcome measures
| Measure |
Placebo
n=54 Participants
Placebo
1x/day during 5 days 3x/week afterwards
|
Azithromycin
n=55 Participants
Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards
|
|---|---|---|
|
Proportion of Participants Using Rescue Medication From Baseline to Week 26
|
0.24 proportion of participants
Standard Deviation 2.11
|
0.08 proportion of participants
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: from baseline to week 26Population: intention to treat analysis
change in peak expiratory volume peak expiratory volume is measured as a maximal expiration for 1 second
Outcome measures
| Measure |
Placebo
n=54 Participants
Placebo
1x/day during 5 days 3x/week afterwards
|
Azithromycin
n=55 Participants
Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards
|
|---|---|---|
|
Peakflow Measurements
morning Peak Expiratory Volume
|
-5.77 L/min
Standard Deviation 48.20
|
-1.81 L/min
Standard Deviation 54.27
|
|
Peakflow Measurements
evening Peak Expiratory Volume
|
-4.65 L/min
Standard Deviation 78.68
|
-0.81 L/min
Standard Deviation 48.47
|
SECONDARY outcome
Timeframe: from baseline to week 26Population: intention to treat analysis
Outcome measures
| Measure |
Placebo
n=54 Participants
Placebo
1x/day during 5 days 3x/week afterwards
|
Azithromycin
n=55 Participants
Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards
|
|---|---|---|
|
Change in Forced Expiratory Volume in 1 Second
post-bronchodilatator FEV1
|
-0.66 percentage of baseline FEV1
Standard Deviation 1.29
|
8.84 percentage of baseline FEV1
Standard Deviation 12.50
|
|
Change in Forced Expiratory Volume in 1 Second
pre-bronchodilatator FEV1
|
-0.90 percentage of baseline FEV1
Standard Deviation 11.79
|
-0.02 percentage of baseline FEV1
Standard Deviation 10.06
|
SECONDARY outcome
Timeframe: from baseline to week 26Population: intention to treat analysis
A simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment. ACQ has a multidimensional construct assessing symptoms (5 items--self-administred) and rescue inbronchodilator use (1 item-self-administered), and FEV1% (1 item) completed by clinic staff Scaling of items: 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%) Scores range between 0 (totally controlled) and 6 (severely uncontrolled).
Outcome measures
| Measure |
Placebo
n=54 Participants
Placebo
1x/day during 5 days 3x/week afterwards
|
Azithromycin
n=55 Participants
Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards
|
|---|---|---|
|
Change in Total Score on Asthma Control Questionnaire (ACQ)
|
-0.12 units on a scale
Standard Deviation 0.70
|
-0.24 units on a scale
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: from baseline to week 26Population: intention to treat analysis
A disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease 32 items with 2-week recall: Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items) 7-point Likert scale (7 = not impaired at all - 1 = severely impaired). Scores range 1-7, with higher scores indicating better quality of life.
Outcome measures
| Measure |
Placebo
n=54 Participants
Placebo
1x/day during 5 days 3x/week afterwards
|
Azithromycin
n=55 Participants
Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards
|
|---|---|---|
|
Change in Total Score on the Asthma-related Quality of Life (AQLQ)
|
0.20 units on a scale
Standard Deviation 0.73
|
0.32 units on a scale
Standard Deviation 0.89
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 39 other events
Deaths: 0 deaths
Azithromycin
Serious events: 7 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=54 participants at risk
Placebo
1x/day during 5 days 3x/week afterwards
|
Azithromycin
n=55 participants at risk
Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards
|
|---|---|---|
|
Blood and lymphatic system disorders
deep venous trombosis
|
0.00%
0/54 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
1.8%
1/55 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
|
Blood and lymphatic system disorders
cerebrovascular accident
|
0.00%
0/54 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
1.8%
1/55 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
|
Gastrointestinal disorders
gastro-enteritis
|
0.00%
0/54 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
1.8%
1/55 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
asthma exacerbation
|
3.7%
2/54 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
5.5%
3/55 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
1.9%
1/54 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
0.00%
0/55 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
|
Cardiac disorders
acute myocardial infarction
|
1.9%
1/54 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
0.00%
0/55 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
|
Gastrointestinal disorders
oesophagitis grade A
|
0.00%
0/54 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
1.8%
1/55 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
|
Musculoskeletal and connective tissue disorders
pseudoparalysis right shoulder
|
0.00%
0/54 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
1.8%
1/55 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
Other adverse events
| Measure |
Placebo
n=54 participants at risk
Placebo
1x/day during 5 days 3x/week afterwards
|
Azithromycin
n=55 participants at risk
Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
lower respiratory tract infection
|
40.7%
22/54 • Number of events 34 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
30.9%
17/55 • Number of events 24 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
asthma exacerbation
|
50.0%
27/54 • Number of events 41 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
47.3%
26/55 • Number of events 40 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
|
Gastrointestinal disorders
nausea
|
3.7%
2/54 • Number of events 2 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
1.8%
1/55 • Number of events 1 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
|
Nervous system disorders
headache
|
5.6%
3/54 • Number of events 3 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
5.5%
3/55 • Number of events 4 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
|
Gastrointestinal disorders
diarrhea
|
13.0%
7/54 • Number of events 8 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
5.5%
3/55 • Number of events 3 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
|
Gastrointestinal disorders
abdominal pain
|
11.1%
6/54 • Number of events 8 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
3.6%
2/55 • Number of events 2 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
|
Nervous system disorders
vertigo
|
1.9%
1/54 • Number of events 1 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
3.6%
2/55 • Number of events 2 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
|
Immune system disorders
allergic reaction
|
1.9%
1/54 • Number of events 1 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
3.6%
2/55 • Number of events 2 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
|
Hepatobiliary disorders
elevated liver function event
|
0.00%
0/54 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
3.6%
2/55 • Number of events 2 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
0.00%
0/54 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
1.8%
1/55 • Number of events 1 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
|
Blood and lymphatic system disorders
leucopenia
|
0.00%
0/54 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
1.8%
1/55 • Number of events 1 • from randomisation to exit visit (during the whole study period, at least 24 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place