Clinical Trial Results:
A single arm, open-label clinical trial of azithromycin in pulmonary sarcoidosis
Summary
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EudraCT number |
2019-000580-24 |
Trial protocol |
GB |
Global end of trial date |
09 Sep 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
12 Jun 2022
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First version publication date |
12 Jun 2022
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Other versions |
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Summary report(s) |
Study summary |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
R2347
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Hull University Teaching Hospitals NHS Trust
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Sponsor organisation address |
Castle Hill Hospital, Castle Road, Cottingham, Kingston-upon-Hull, United Kingdom, HU16 5JQ
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Public contact |
Dr Simon Hart, Hull York Medical School/ University of Hull, +44 01482624067, s.hart@hull.ac.uk
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Scientific contact |
Dr Simon Hart, Hull York Medical School/ University of Hull, +44 01482624067, s.hart@hull.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
09 Sep 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
09 Sep 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
09 Sep 2020
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
Assess the effect of azithromycin on cough measured using automated cough counting
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Protection of trial subjects |
The investigator or designee will question subjects about AEs and intercurrent illnesses at
Baseline and at all subsequent visits since their last visit. The pertinent information will be
recorded on the CRF.
Safety will be assessed through monitoring of adverse events/serious adverse events of special
interest, physical examinations, vital signs, and 12-lead ECGs. Safety assessment frequency is
shown in the Schedule of Assessments and Procedures
Robust consent process in place.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Mar 2019
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 21
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Worldwide total number of subjects |
21
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
18
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From 65 to 84 years |
3
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||
Pre-assignment
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Screening details |
Once informed consent has been obtained, the following assessments will be performed and recorded: • Medical history and demographics • Vital signs (sitting systolic and diastolic blood pressure, pulse, respiration rate, body temperature) • Weight and height • Physical examination • ECG (12 lead)Concomitant medication • Cough VAS • LCQ • | ||||||
Period 1
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Period 1 title |
Visit 1
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Test | ||||||
Arm description |
The Screening/baseline visit will ensure that each subject meets all the specified inclusion criteria and none of the exclusion criteria. Once consented, the Hull Automated Cough Counter will be given to the patient with verbal and written instructions. The initial supply of study drug (azithromycin 250mg once daily) will be issued, with written instructions to take the first dose on the day after completing the cough counting. The subject will return the cough counter for analysis at their convenience. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Azithromycin 250mg
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Commercially available 250 mg azithromycin, administered as a tablet
oral azithromycin 250 mg once daily for 3 months
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Period 2
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Period 2 title |
Visit 2
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Is this the baseline period? |
No | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Test | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Azithromycin 250mg
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Commercially available 250 mg azithromycin, administered as a tablet
oral azithromycin 250 mg once daily for 3 months
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Notes [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period. Justification: 1 participant left the trial due at 1 month due to work commitments. |
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Period 3
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Period 3 title |
Visit 3
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Is this the baseline period? |
No | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Test | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Azithromycin 250mg
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Commercially available 250 mg azithromycin, administered as a tablet
oral azithromycin 250 mg once daily for 3 months
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End points reporting groups
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Reporting group title |
Test
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Reporting group description |
The Screening/baseline visit will ensure that each subject meets all the specified inclusion criteria and none of the exclusion criteria. Once consented, the Hull Automated Cough Counter will be given to the patient with verbal and written instructions. The initial supply of study drug (azithromycin 250mg once daily) will be issued, with written instructions to take the first dose on the day after completing the cough counting. The subject will return the cough counter for analysis at their convenience. | ||
Reporting group title |
Test
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Reporting group description |
- | ||
Reporting group title |
Test
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Reporting group description |
- |
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End point title |
24hr Cough count | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
24hr
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Statistical analysis title |
p-value | ||||||||||||||||
Comparison groups |
Test v Test v Test
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Number of subjects included in analysis |
61
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.006 | ||||||||||||||||
Method |
Chi-squared | ||||||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
The investigator or designee will question subjects about AEs and intercurrent illnesses at
Baseline and at all subsequent visits since their last visit. The pertinent information will be
recorded on the CRF.
Safety will be assessed through monitoring
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
15.1
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Reporting groups
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Reporting group title |
Common cold
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Gastrointestinal symptoms
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Transient worsening cough
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||||||
Interruptions (globally) |
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Were there any global interruptions to the trial? Yes | |||||||
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Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
None reported |