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Trial record 93 of 532 for:    Taste Disorders

The Anti-inflammatory Effect of Prophylactic Macrolides on Children With Chronic Lung Disease

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ClinicalTrials.gov Identifier: NCT02544984
Recruitment Status : Completed
First Posted : September 9, 2015
Results First Posted : June 5, 2018
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Ricardo A. Mosquera, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Chronic Lung Disease
Interventions Drug: Azithromycin
Drug: placebo
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Azithromycin
Hide Arm/Group Description The control group will be provided with a placebo medication of similar taste, color, texture, and consistency as the study medication. Patients will receive placebo at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period. The azithromycin group will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
Period Title: Overall Study
Started 30 30
Completed 28 28
Not Completed 2 2
Arm/Group Title Placebo Azithromycin Total
Hide Arm/Group Description The control group will be provided with a placebo medication of similar taste, color, texture, and consistency as the study medication. Patients will receive placebo at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period. The azithromycin group will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period. Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Number Analyzed 30 participants 30 participants 60 participants
6 -24 months
19
  63.3%
19
  63.3%
38
  63.3%
24 months-72 months
11
  36.7%
11
  36.7%
22
  36.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
16
  53.3%
11
  36.7%
27
  45.0%
Male
14
  46.7%
19
  63.3%
33
  55.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Hispanic or Latino
17
  56.7%
14
  46.7%
31
  51.7%
Not Hispanic or Latino
13
  43.3%
16
  53.3%
29
  48.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   3.3%
1
   3.3%
2
   3.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
  30.0%
10
  33.3%
19
  31.7%
White
1
   3.3%
2
   6.7%
3
   5.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
19
  63.3%
17
  56.7%
36
  60.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 60 participants
30
 100.0%
30
 100.0%
60
 100.0%
Gestational Age  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<28 weeks
22
  73.3%
20
  66.7%
42
  70.0%
28-31 weeks
6
  20.0%
4
  13.3%
10
  16.7%
32-36 weeks
2
   6.7%
6
  20.0%
8
  13.3%
Number of Participants who Received Synagis Injection  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
14
  46.7%
16
  53.3%
30
  50.0%
Number of Patients with Tracheostomy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
5
  16.7%
5
  16.7%
10
  16.7%
1.Primary Outcome
Title Number of Unscheduled Face-to-face Physician Visits (Clinic Visits, ER Visits, and Hospitalizations)
Hide Description Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time at the end of the winter season, which accounts for the variability in the amount of time participants were observed.
Time Frame 5 to 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Azithromycin
Hide Arm/Group Description:
The control group will be provided with a placebo medication of similar taste, color, texture, and consistency as the study medication. Patients will receive placebo at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
The azithromycin group will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: visits
Unscheduled clinic visits for respiratory symptoms 16 21
Unscheduled clinic visits for other symptoms 3 5
Emergency room visits 15 6
Hospital admissions 6 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Azithromycin
Comments The numbers of unscheduled clinic visits due to respiratory symptoms are compared.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.473
Comments [Not Specified]
Method negative binomial model
Comments negative binomial model adjusting for use of Synagis and tracheostomy
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Azithromycin
Comments Unscheduled clinic visits due to symptoms other than respiratory symptoms are compared
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.505
Comments [Not Specified]
Method negative binomial model
Comments negative binomial model adjusting for use of Synagis and tracheostomy
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Azithromycin
Comments Numbers of emergency room visits are compared
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method negative binomial model
Comments negative binomial model adjusting for use of Synagis and tracheostomy
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Azithromycin
Comments Numbers of hospital admissions are compared
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.675
Comments [Not Specified]
Method negative binomial model
Comments negative binomial model adjusting for use of Synagis and tracheostomy
2.Secondary Outcome
Title Number of Adverse Events
Hide Description Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time at the end of the winter season, which accounts for the variability in the amount of time participants were observed.
Time Frame 5 to 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Azithromycin
Hide Arm/Group Description:
The control group will be provided with a placebo medication of similar taste, color, texture, and consistency as the study medication. Patients will receive placebo at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
The azithromycin group will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: adverse events
4 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Azithromycin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.435
Comments [Not Specified]
Method negative binomial model
Comments negative binomial model adjusting for use of Synagis and tracheostomy
3.Secondary Outcome
Title Healthcare Cost Associated With Respiratory Illness
Hide Description Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time during the end of the winter season, which accounts for the variability in the amount of time participants were observed.
Time Frame 5 to 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
Cost-effective analyses are only justified for interventions that are shown to be effective. Because the intervention at study (the macrolide azithromycin) showed no benefit and led to worse outcomes than those with usual care, an economic evaluation is not warranted and claims data was not collected.
Arm/Group Title Placebo Azithromycin
Hide Arm/Group Description:
The control group will be provided with a placebo medication of similar taste, color, texture, and consistency as the study medication. Patients will receive placebo at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
The azithromycin group will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Other Pre-specified Outcome
Title Long Term Reduction in Respiratory Symptoms
Hide Description To determine if prophylactic use of azithromycin will reduce the total number of unscheduled face-to-face physician visit for respiratory related illness in a clinic, urgent care, emergency room or hospital setting during the following 12 months after the intervention.
Time Frame 12 months
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title Level of Airway Conductance
Hide Description To determine if prophylactic use of azithromycin will reduce level of airway resistance as measured by an Airwave Oscillometry System in subjects above 2 years of age, at the time of respiratory illnesses, during the 3-6 months intervention.
Time Frame 6 months
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Level of Cytokines
Hide Description Using a standardize nasal wash procedure, respiratory samples will be collected at enrollment, at end of study, and during acute respiratory illness requiring face-to-face provider interaction. Children with a tracheostomy will have both a nasal wash sample and a tracheal aspirate sample collected. The respiratory samples will be stabilized with a universal transport media, processed and stored at -80 C for future testing. Testing will be performed for cytokines/chemokines; other biomarkers of disease such as LDH, MPO, and caspase; viral and bacterial respiratory pathogens; and microbiome.
Time Frame 8 months
Outcome Measure Data Not Reported
Time Frame 5 to 8 months - Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time during the end of the winter season, which accounts for the variability in the amount of time participants were observed.
Adverse Event Reporting Description Parents were contacted biweekly, either in clinic or by phone, to monitor for any adverse reactions, including rash, nausea, vomiting, diarrhea, or abdominal cramping.
 
Arm/Group Title Placebo Azithromycin
Hide Arm/Group Description The control group will be provided with a placebo medication of similar taste, color, texture, and consistency as the study medication. Patients will receive placebo at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period. The azithromycin group will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
All-Cause Mortality
Placebo Azithromycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)      0/28 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Azithromycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/28 (0.00%)      0/28 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Azithromycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/28 (10.71%)      2/28 (7.14%)    
Gastrointestinal disorders     
Diarrhea   2/28 (7.14%)  2 0/28 (0.00%)  0
Vomiting   2/28 (7.14%)  2 1/28 (3.57%)  1
Skin and subcutaneous tissue disorders     
Rash   0/28 (0.00%)  0 1/28 (3.57%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Ricardo A. Mosquera, MD
Organization: The University of Texas Health Science Center at Houston
Phone: (713) 500-5650
Responsible Party: Ricardo A. Mosquera, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02544984     History of Changes
Other Study ID Numbers: HSC-MS-14-0476
First Submitted: September 4, 2015
First Posted: September 9, 2015
Results First Submitted: March 21, 2018
Results First Posted: June 5, 2018
Last Update Posted: June 5, 2018