MedDataX Logo

Trial Outcomes & Findings for Asthma Clinical Research Network (ACRN) Trial - Macrolides in Asthma (MIA) (NCT NCT00318708)

NCT ID: NCT00318708

Last Updated: 2018-03-23

Results Overview

The Juniper asthma control questionnaire (ACQ) consists of six questions answered by the asthma patient with respect to symptoms, rescue medication use, and night-time awakenings due to asthma. A seventh item in the ACQ is the percent predicted FEV1. Each of the seven items is scored from from 0 (best) to 6 (worst), and then the seven items are averaged to yield a number from 0 (best) to 6 (worst). Asthma patients needed to display an ACQ greater than or equal to 1.25 in order to be eligible for randomization. A reduction of 0.5 units or more in the ACQ over the 16 weeks of treatment is considered to be clinically significant.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

92 participants

Primary outcome timeframe

Measured every four weeks during the 16-week treatment period, with the change (week 16 minus baseline) as the primary outcome

Results posted on

2018-03-23

Participant Flow

Participant milestones

Participant milestones
Measure
Clarithromycin + Fluticasone
clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Placebo + Fluticasone
placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Overall Study
STARTED
47
45
Overall Study
8-week Milestone
42
42
Overall Study
COMPLETED
39
40
Overall Study
NOT COMPLETED
8
5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Asthma Clinical Research Network (ACRN) Trial - Macrolides in Asthma (MIA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Clarithromycin + Fluticasone
n=47 Participants
Clarithromycin 500 mg bid (Biaxin) + fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
Placebo + Fluticasone
n=45 Participants
Fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
Total
n=92 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
47 Participants
n=93 Participants
45 Participants
n=4 Participants
92 Participants
n=27 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Continuous
41.3 years
STANDARD_DEVIATION 12.5 • n=93 Participants
37.5 years
STANDARD_DEVIATION 10.5 • n=4 Participants
39.5 years
STANDARD_DEVIATION 11.5 • n=27 Participants
Sex: Female, Male
Female
27 Participants
n=93 Participants
25 Participants
n=4 Participants
52 Participants
n=27 Participants
Sex: Female, Male
Male
20 Participants
n=93 Participants
20 Participants
n=4 Participants
40 Participants
n=27 Participants
Region of Enrollment
United States
47 participants
n=93 Participants
45 participants
n=4 Participants
92 participants
n=27 Participants

PRIMARY outcome

Timeframe: Measured every four weeks during the 16-week treatment period, with the change (week 16 minus baseline) as the primary outcome

Population: The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).

The Juniper asthma control questionnaire (ACQ) consists of six questions answered by the asthma patient with respect to symptoms, rescue medication use, and night-time awakenings due to asthma. A seventh item in the ACQ is the percent predicted FEV1. Each of the seven items is scored from from 0 (best) to 6 (worst), and then the seven items are averaged to yield a number from 0 (best) to 6 (worst). Asthma patients needed to display an ACQ greater than or equal to 1.25 in order to be eligible for randomization. A reduction of 0.5 units or more in the ACQ over the 16 weeks of treatment is considered to be clinically significant.

Outcome measures

Outcome measures
Measure
Clarithromycin + Fluticasone
n=39 Participants
clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Placebo + Fluticasone
n=39 Participants
placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Juniper Asthma Control Questionnaire (ACQ) Results
-0.15 units on a scale
Standard Error 0.14
-0.38 units on a scale
Standard Error 0.14

SECONDARY outcome

Timeframe: the week-16 average minus the baseline-week average

Population: The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).

number of rescue puffs per day

Outcome measures

Outcome measures
Measure
Clarithromycin + Fluticasone
n=39 Participants
clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Placebo + Fluticasone
n=39 Participants
placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Asthma Rescue Medication Use
-0.71 rescue puffs per day
Standard Error 0.23
-0.14 rescue puffs per day
Standard Error 0.24

SECONDARY outcome

Timeframe: the week-16 average minus the baseline-week average

Population: The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).

daily AM peak expiratory flow (PEF) measured in liters per minute

Outcome measures

Outcome measures
Measure
Clarithromycin + Fluticasone
n=39 Participants
clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Placebo + Fluticasone
n=39 Participants
placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
AM Peak Expiratory Flow (PEF)
8.31 liters per minute
Standard Error 4.55
11.69 liters per minute
Standard Error 4.48

SECONDARY outcome

Timeframe: the week-16 value minus the baseline-value

Population: The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).

Forced expiratory volume in one second (FEV1) from spirometry

Outcome measures

Outcome measures
Measure
Clarithromycin + Fluticasone
n=39 Participants
clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Placebo + Fluticasone
n=39 Participants
placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Forced Expiratory Volume in One Second (FEV1)
-0.08 Liters
Standard Error 0.05
-0.06 Liters
Standard Error 0.06

SECONDARY outcome

Timeframe: the week-16 value minus the baseline-value

Population: The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).

Logarithm-base 2 transformed Methacholine provocative concentration (PC20) based on FEV1

Outcome measures

Outcome measures
Measure
Clarithromycin + Fluticasone
n=39 Participants
clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Placebo + Fluticasone
n=39 Participants
placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Methacholine Provocative Concentration (PC20)
1.39 logarithm-base 2 of mg/mL
Standard Error 0.30
0.41 logarithm-base 2 of mg/mL
Standard Error 0.30

SECONDARY outcome

Timeframe: the week-16 value minus the baseline-value

Population: The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).

Exhaled nitric oxide (eNO) measured in parts per billion

Outcome measures

Outcome measures
Measure
Clarithromycin + Fluticasone
n=39 Participants
clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Placebo + Fluticasone
n=39 Participants
placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Exhaled Nitric Oxide (eNO)
-0.33 parts per billion
Standard Error 3.16
3.04 parts per billion
Standard Error 3.26

SECONDARY outcome

Timeframe: the week-16 value minus the baseline-value

Population: The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).

The Asthma Quality of Life Questionnaire (AQLQ) consists of 32 questions, with each question ranging from 1 (worst) to 7 (best). The 32 questions are averaged to yield an overall score, which is reported here. Therefore, a positive change between the 16-week score and the baseline score represents improvement.

Outcome measures

Outcome measures
Measure
Clarithromycin + Fluticasone
n=39 Participants
clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Placebo + Fluticasone
n=39 Participants
placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Asthma Quality of Life Questionnaire (AQLQ)
0.41 units on a scale (1 through 7)
Standard Error 0.16
0.59 units on a scale (1 through 7)
Standard Error 0.15

Adverse Events

Clarithromycin + Fluticasone

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Placebo + Fluticasone

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Clarithromycin + Fluticasone
n=47 participants at risk
Clarithromycin 500 mg bid (Biaxin) + fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
Placebo + Fluticasone
n=45 participants at risk
Fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
Respiratory, thoracic and mediastinal disorders
respiratory infections
10.6%
5/47 • Number of events 5 • 6 months
does not differ from clinicaltrials.gov definitions
11.1%
5/45 • Number of events 5 • 6 months
does not differ from clinicaltrials.gov definitions
Gastrointestinal disorders
gastrointestinal events
14.9%
7/47 • Number of events 9 • 6 months
does not differ from clinicaltrials.gov definitions
6.7%
3/45 • Number of events 5 • 6 months
does not differ from clinicaltrials.gov definitions

Additional Information

Vernon M. Chinchilli, PhD

Penn State Hershey College of Medicine

Phone: 717-531-4262

Results disclosure agreements

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