Sarcoidosis
Conditions
Interventions
Trade Name: Azithromycin
Product Name: Azithromycin
Pharmaceutical Form: Tablet
INN or Proposed INN: azithromycin monohydrate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentratio
Sponsors
Hull & East Yorkshire Hospitals NHS trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females, of any race, between 18 and 80 years of age, inclusive; 2. Able to speak, read, and understand English; 3. Able to provide written informed consent; 4. Able to communicate effectively with the Investigator and other study centre personnel and agree to comply with the study procedures and restrictions. 5. Clinician diagnosis of pulmonary sarcoidosis; 6. If a female of child-bearing potential (i.e., have not undergone a hysterectomy or bilateral oophorectomy) or not post-menopausal (defined as no menses for at least 12 months), agree to use acceptable birth control (defined in Section 6.3) from screening through to the follow up visit; Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to azithromycin or another macrolide antibiotic (e.g. erythromycin, clarithromycin) or excipients 2. History of signficant cardiac arrhythmia 3. Personal or family history of congenital long QT syndrome; 4. Prolonged QTc interval on 12–lead ECG 5. Severe liver disease 6. Evidence of acute bacterial infection 7. Clinically significant bronchiectasis 8. Requiring concomitant therapy with prohibited medications (see Section 7.5) 9. Pregnant or breastfeeding; 10. Treatment with an investigational drug or biologic within 30 days preceding the first dose of study medication or plans to take another investigational drug or biologic within 30 days of study completion; 11. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the subject inappropriate for entry into this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the effect of azithromycin on cough measured using automated cough counting ;Secondary Objective: Assess the effect of azithromycin on : • Cough visual analogue score (VAS) • Leicester cough questionnaire (LCQ) • King’s Sarcoidosis Questionnaire (KSQ) • Clinical measurement as part of NHS care in the Sarcoidosis clinic over the study period will be recorded. Spirometry, chest x-ray, serum ACE, CRP are routinely measured. Progressive disease requiring escalation of therapy with steroids will be determined in the standard way by clinical MDT consensus. • Exploratory variables in blood samples: a) Anti-inflammatory activity of azithromycin assessed by cytokine release in an ex vivo whole blood assay b) Engagement of drug with target by measuring mTOR activation in peripheral blood mononuclear cells. • Variability of outcomes described above to inform statistical power calculations and determine sample size for a future RCT • Feasibility assessment for a multicentre trial of long term azithromycin therapy in sarcoidosis by measuring screening success rates, recruitment, attrition, an;Primary end point(s): Cough assessed by: - Hull Automated Cough Counter (HACC) with the Leicester software algorithm Coughs will be counted over a 24-hour period after visits 1,2, and 3 using a digital portable cough counter that has been shown to be reliable and reproducible in counting coughs in a variety of conditions and settings. This cough counter discriminates cough from other sounds by analysing cough sounds acoustically. The cough counter will be returned or collected for analysis following visits 1, 2, and 3.;Timepoint(s) of evaluation of this end point: Baseline, 1 month, 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cough visual analogue score (VAS) Leicester cough questionnaire (LCQ). King’s Sarcoidosis Questionnaire (KSQ) Clinical measurement as part of NHS care in the Sarcoidosis clinic over the study period will be recorded. Spirometry, chest x-ray, serum ACE, CRP are routinely measured. Progressive disease requiring escalation of therapy with steroids will be determined in the standard way by clinical MDT consensus. Blood will be analysed for exploratory variables: a) Anti-inflammatory activity of azithromycin assessed by cytokine release in an ex vivo whole blood assay b) Engagement of drug with target by measuring mTOR activation in peripheral blood mononuclear cells. •Variability of outcomes described above to inform statistical power calculations and determine sample size for a future RCT •Feasibility assessment for a multicentre trial of long term azithromycin therapy in sarcoidosis by measuring screening success rates, recruitment, attrition, and data quality. ;Timepoint(s) of evaluation of this end point: Baseline, 1 month, 3 months | — |
Countries
United Kingdom
Contacts
Public ContactDr Simon Hart
Hull York Medical School/ University of Hull
Outcome results
None listed