Sarcoidosis, Pulmonary Clinical Trial
— CAPSOfficial title:
A Single Arm, Open-label Exploratory Clinical Trial of Azithromycin in Pulmonary Sarcoidosis
Verified date | July 2020 |
Source | Hull University Teaching Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients with sarcoidosis need treatment options that effectively control their disease
without causing undesirable side effects. An appealing strategy is to repurpose existing
drugs which possess beneficial immune modulating activity and are safe for long-term use.
Recently, increased activity of the mTOR intracellular signalling pathway in inflammatory
cells has emerged as a key driver of granulomatous inflammation in mouse models and patients
with sarcoidosis. The macrolide antibiotic azithromycin directly inhibits mTOR activity in
inflammatory cells, making it a prime target for drug repurposing in sarcoidosis.
Azithromycin has an acceptable tolerability profile when used for long-term treatment of
other chronic respiratory disease Single centre open label clinical trial of oral
azithromycin 250 mg once daily for 3 months in 20-30 patients with pulmonary sarcoidosis.
The Investigator have opted for an open label study because this will be the first study of
azithromycin in sarcoidosis. Trial assessments will be performed according to standards of
Good Clinical Practice with assessments at baseline, 1, and 3 months. All other clinical
care, investigations, and treatment (if indicated) will remain the responsibility of the
treating physician and based on clinical MDT consensus decisions.
Status | Completed |
Enrollment | 21 |
Est. completion date | June 20, 2020 |
Est. primary completion date | June 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - • Males or females, of any race, between 18 and 80 years of age, inclusive; - Able to speak, read, and understand English; - Able to provide written informed consent; - Able to communicate effectively with the Investigator and other study centre personnel and agree to comply with the study procedures and restrictions. - Clinician diagnosis of pulmonary sarcoidosis; - 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; Exclusion Criteria: - • Hypersensitivity to azithromycin or another macrolide antibiotic (e.g. erythromycin, clarithromycin) or excipients (see 7.4) - History of signficant cardiac arrhythmia - Personal or family history of congenital long QT syndrome; - Prolonged QTc interval on 12-lead ECG - Signficant liver disease - Evidence of acute bacterial infection - Clinically significant bronchiectasis - Requiring concomitant therapy with prohibited medications (see Section 7.5) - Pregnant or breastfeeding; - 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; - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Respiratory Medicine Clinical trials Unit | Cottingham | East Yorkshire |
Lead Sponsor | Collaborator |
---|---|
Hull University Teaching Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in 24 hr cough counts from baseline | 24n hr cough monitoring with ambulatory cough monitor will be performed at baseline and at 1mth and 3 months post treatment | 3 months | |
Secondary | Mean Change in severity of cough from baseline | Severity of cough will be scored on a visual anolgue scale at baseline and at 1month and 3 months post treatment | 3 months | |
Secondary | Mean Change in urge to cough from baseline | Urge to cough will be scored on a visual analogue scale at baseline and at 1 month and 3 months post treatment | 3 months | |
Secondary | Mean Change in Leicester cough questionnaire total score from baseline | The Leicester cough questionnaire will be performed at baseline and at 1 month and 3 months post treatment. | 3 months | |
Secondary | Mean Change in Kings sarcoidosis questionnaire total score from baseline | Kings sarcoidosis questionniare will be completed at baseline and compared with that at 1 month and 3 months post azithromycin | 3 months |
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