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Efficacy of Azithromycin in Treatment of Bronchiectasis

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ClinicalTrials.gov Identifier: NCT02107274
Recruitment Status : Completed
First Posted : April 8, 2014
Results First Posted : July 9, 2014
Last Update Posted : July 18, 2014
Sponsor:
Information provided by (Responsible Party):
ALBERT IRUTHIARAJ L. ANTHONY, Ministry of Health, Malaysia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Bronchiectasis
Interventions Drug: Azithromycin
Drug: Placebo for Azithromycin
Enrollment 78
Recruitment Details A total of 90 subjects with a High Resolution CT scan diagnosis of pulmonary bronchiectasis was recruited from January - October 2011. Recruitment was done amongst patients in chest clinic, Hospital Taiping. A total of 78 subjects were selected based on the inclusion and exclusion criterias.
Pre-assignment Details 12 subjects were excluded from randomization as they did not have chronic sputum production and were unable to perform spirometry.
Arm/Group Title Azithromycin and Placebo for Azithromycin Placebo for Azithromycin
Hide Arm/Group Description Patients randomised to the treatment arm received 1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks. Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
Period Title: Treatment vs. Placebo
Started 39 39
Completed 36 37
Not Completed 3 2
Reason Not Completed
Adverse Event             3             0
Lost to Follow-up             0             2
Period Title: Control Phase
Started 36 37
Completed 33 35
Not Completed 3 2
Reason Not Completed
Lost to Follow-up             1             1
Death             2             0
Adverse Event             0             1
Arm/Group Title Azithromycin Placebo for Azithromycin Total
Hide Arm/Group Description Patients randomised to the treatment arm received 1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks. Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 33 35 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 35 participants 68 participants
65.9  (11.77) 59.7  (15.03) 62.8  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 35 participants 68 participants
Female
18
  54.5%
22
  62.9%
40
  58.8%
Male
15
  45.5%
13
  37.1%
28
  41.2%
Sputum volume   [1] 
Mean (Standard Deviation)
Unit of measure:  Gram
Number Analyzed 33 participants 35 participants 68 participants
41.8  (26.05) 23.6  (20.67) 32.4  (24.99)
[1]
Measure Description: Higher sputum volume indicates active disease process and poorer morbidity. Lower sputum volume is associated with better control of disease process.
St George's Respiratory Questionnaire (SGRQ) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 33 participants 35 participants 68 participants
41.06  (9.95) 36.40  (10.59) 38.66  (10.47)
[1]
Measure Description: St George's Respiratory Questionnaire (SGRQ) score measures quality of life in patients with chronic lung disease. Score can range from 10 (minimum) until 100 (maximum). Lower scores are associated with good quality of life and the higher scores indicates poor quality of life. Total score is a product of summation of individual scores per question.
Forced Expiratory Volume at 1 second (FEV1)   [1] 
Mean (Standard Deviation)
Unit of measure:  Litres
Number Analyzed 33 participants 35 participants 68 participants
1.08  (0.41) 1.17  (0.54) 1.13  (0.48)
[1]
Measure Description: Forced expiratory volume at 1 second (FEV1) is a reflection of lung volume. Higher values reflect less airflow limitation and good lung reserve. Lower values indicate poor airflow limitation and lower lung reserve.
Forced Vital Capacity (FVC)   [1] 
Mean (Standard Deviation)
Unit of measure:  Litres
Number Analyzed 33 participants 35 participants 68 participants
1.56  (0.65) 1.69  (0.74) 1.63  (0.70)
[1]
Measure Description: Forced vital capacity (FVC) is a measurement of lung volume. Higher values reflect better reserve meanwhile lower values indicate poorer reserve.
1.Primary Outcome
Title 24 Hour Sputum Volume
Hide Description Each participant must be instructed and enabled to collect 24 hour sputum volumes over the 24 hours prior to visits 3, 6 and 8, inclusive. As this is the primary endpoint of the study, it is critical that 24 hour sputum volumes are measured and recorded accurately, observing the following protocol: The subject should be given a sterile jar to collect the sputum, which has been weighed previously for convenience. Each jar will be labelled with subject name, start and finish time/date The collection should commence on rising in the morning and complete 24 hours later. Ensure that the sputum sample has minimal saliva in the collection Instruct subject to collect all sputum produced spontaneously or after coughing over a single daytime 24 hour period. The sample should come from the lungs and should not be salivary. Encourage subject not to swallow sputum, but to collect. Each 24 hour collection period should be as similar as possible in terms of physiotherapy and exercise regimens
Time Frame Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 90 subjects were recruited. Among them, 78 subjects fulfilled the inclusion criteria and were randomized. Only 68 subjects completed the study and were subjected for analysis. We targeted to recruit 80 subjects and a dropout rate of 20% was anticipated as stated in the protocol.
Arm/Group Title Azithromycin Placebo for Azithromycin
Hide Arm/Group Description:
Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
Overall Number of Participants Analyzed 33 35
Mean (Standard Deviation)
Unit of Measure: gram
Visit 3(Baseline) 41.8  (26.1) 23.6  (20.7)
Visit 6(Week 12) 29.9  (19.4) 26.2  (20.5)
Visit 8(Week 24) 30.4  (20.6) 28.5  (21.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin
Comments

Sputum volume were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).

Independent t-test was applied for study end points which were numerical variables.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments P value of less than 0.05 was considered as significant.
Method t-test, 1 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for Azithromycin
Comments

Sputum volume were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).

Independent t-test was applied for study end points which were numerical variables.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments P value of less than 0.05 was considered significant.
Method t-test, 1 sided
Comments [Not Specified]
2.Secondary Outcome
Title Health Status: St George's Respiratory Questionnaire Score
Hide Description The St. George Respiratory Questionnaire is to be administered at visits 3, 6 and 8 inclusive. It should be administered in a quiet room where the participant can answer the questions without interruption, prior to any other protocol related procedures
Time Frame Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azithromycin Placebo for Azithromycin
Hide Arm/Group Description:
Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
Overall Number of Participants Analyzed 33 35
Mean (Standard Deviation)
Unit of Measure: Units
Visit 3(Baseline) 41.1  (9.9) 36.4  (10.6)
Visit 6(Week 12) 30.2  (8.5) 39.1  (9.3)
Visit 8(Week 24) 31.7  (8.1) 41.1  (11.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin
Comments

SGRQ scores were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).

Independent t-test was applied for study end points which were numerical variables.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments P value of less than 0.05 was considered as significant.
Method t-test, 1 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for Azithromycin
Comments

SGRQ scores were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).

Independent t-test was applied for study end points which were numerical variables

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments p valu of less than 0.05 was considered significant.
Method t-test, 1 sided
Comments [Not Specified]
3.Secondary Outcome
Title Spirometry Value; Forced Expiratory Volume at 1 Second (FEV1)
Hide Description Pulmonary function testing using a spirometer will be carried out at visits 3, 6 and 8 inclusive. All testing should be done in the sitting position, except for obese patients, who commonly obtain deeper inspiration when tested in the standing position. Subjects should avoid the following prior to lung function testing: Smoking within 1 hour of testing Consuming alcohol within 4 hours of testing Performing vigorous exercise within 30 minutes of testing Wearing restrictive clothing around the chest or abdomen Eating a large meal within 2 hours of testing The following medications must be withheld prior to testing, with the minimum time from last dose indicated- short acting beta agonists (6 hours), long acting beta agonists (12 hours), ipratropium bromide (12 hours), antihistamines (12 hours), long acting bronchodilator combinations (12 hours)
Time Frame Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azithromycin Placebo for Azithromycin
Hide Arm/Group Description:
Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
Overall Number of Participants Analyzed 33 35
Mean (Standard Deviation)
Unit of Measure: Litres
Visit 3(Baseline) 1.08  (0.41) 1.17  (0.55)
Visit 6(Week 12) 1.09  (0.40) 1.10  (0.53)
Visit 8(Week 24) 1.04  (0.37) 1.08  (0.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin
Comments

FEV1 values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).

Independent t-test was applied for study end points which were numerical variables.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments P value of less than 0.05 was considered as significant.
Method t-test, 1 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for Azithromycin
Comments

FEV1 values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).

Independent t-test was applied for study end points which were numerical variables.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments p value of less than 0.05 was considered significant
Method t-test, 1 sided
Comments [Not Specified]
4.Secondary Outcome
Title Spirometric Values: Forced Vital Capacity (FVC)
Hide Description Pulmonary function testing using a spirometer will be carried out at visits 3, 6 and 8 inclusive. All testing should be done in the sitting position, except for obese patients, who commonly obtain deeper inspiration when tested in the standing position. Subjects should avoid the following prior to lung function testing: Smoking within 1 hour of testing Consuming alcohol within 4 hours of testing Performing vigorous exercise within 30 minutes of testing Wearing restrictive clothing around the chest or abdomen Eating a large meal within 2 hours of testing The following medications must be withheld prior to testing, with the minimum time from last dose indicated- short acting beta agonists (6 hours), long acting beta agonists (12 hours), ipratropium bromide (12 hours), antihistamines (12 hours), Iong acting bronchodilator combinations (12 hours)
Time Frame Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azithromycin Placebo for Azithromycin
Hide Arm/Group Description:
Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
Overall Number of Participants Analyzed 33 35
Mean (Standard Deviation)
Unit of Measure: Litres
Visit 3(Baseline) 1.56  (0.65) 1.69  (0.74)
Visit 6(Week 12) 1.58  (0.63) 1.60  (0.70)
Visit 8(Week 24) 1.55  (0.66) 1.58  (0.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin
Comments

FVC values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).

Independent t-test was applied for study end points which were numerical variables.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments P value of less than 0.05 was considered as significant.
Method t-test, 1 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for Azithromycin
Comments

FVC values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).

Independent t-test was applied for study end points which were numerical variables.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments p value of less than 0.05 was considered significant.
Method t-test, 1 sided
Comments [Not Specified]
Time Frame Subjects were monitored for adverse drug reactions for 24 weeks. Monitoring included enquiry of symptoms, physical examination and venous sampling at every visit.
Adverse Event Reporting Description Any clinically significant result outside normal ranges from these visits was documented and was reported as an adverse event. The subjects were withdrawn from the trial and then monitoring will continue until resolution or an appropriate medical judgment has been made to determine the cause and severity of the case.
 
Arm/Group Title Azithromycin Placebo for Azithromycin
Hide Arm/Group Description Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks. Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
All-Cause Mortality
Azithromycin Placebo for Azithromycin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Azithromycin Placebo for Azithromycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/33 (15.15%)      4/35 (11.43%)    
Respiratory, thoracic and mediastinal disorders     
Pneumonia Hospitalisations *  3/33 (9.09%)  3 4/35 (11.43%)  4
Pneumonia Deaths *  2/33 (6.06%)  2 0/35 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Azithromycin Placebo for Azithromycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/33 (9.09%)      1/35 (2.86%)    
Gastrointestinal disorders     
Diarrhea * [1]  3/33 (9.09%)  3 1/35 (2.86%)  1
*
Indicates events were collected by non-systematic assessment
[1]
The diarrhea resolved upon discontinuation of study treatment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Albert Iruthiaraj L. Anthony
Organization: Ministry of Health of Malaysia
Phone: +60174633410
Responsible Party: ALBERT IRUTHIARAJ L. ANTHONY, Ministry of Health, Malaysia
ClinicalTrials.gov Identifier: NCT02107274     History of Changes
Other Study ID Numbers: NMRR-09-1075-5016
First Submitted: April 3, 2014
First Posted: April 8, 2014
Results First Submitted: May 6, 2014
Results First Posted: July 9, 2014
Last Update Posted: July 18, 2014