Effects of azithromycin treatment on immunesystem in patients with asthma and COPD
- Conditions
- COPD and asthmaTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2019-003768-31-DK
- Lead Sponsor
- ungemedicinsk Forskningsenhed
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
All subjects
1.Written informed consent.
2.Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from the time informed consent is obtained and must agree to continue using such precautions through Week 14 of the study; cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).
Asthma patients (n=40)
1.Diagnosis of asthma according to GINA, with confirmed variable airflow obstruction at screening visit or previously (52).
2.Age =18 through 75 years.
3.FEV1 value of = 50% predicted.
4.Maintenance treatment with ICS and = 1 second controller (LABA, LAMA, LTRA or Xanthines) for at least three months prior to Visit 1.
5.Non-smokers (<10 packyears, quit >6 months).
6.= 1 Systemic steroid treated exacerbation in the past one year despite maintenance treatment with inhaled corticosteroids.
7.Eosinophilic (n=20, blood eosinophils = 0.200x109/L) and non-eosinophilic (n=20, blood eosinophils <0.200x109/L) phenotypes.
COPD patients (n=40)
1.Diagnosis of COPD according to GOLD (53).
2.Age =45 through 75 years.
3.= 10 packyears smoking history (current or ex-smokers).
4.A postbronchodilator FEV1 = 30% predicted.
5.Maintenance treatment with long-acting bronchodilators (LABA and/or LAMA) with or without ICS.
6.= 1 Systemic steroid and/or antibiotic treated exacerbation in the past one year.
7.Eosinophilic (n=20, blood eosinophils =0.200x109/L) and non-eosinophilic (n=20, blood eosinophils <0.200x109/L) phenotypes.
Healthy controls (n=20)
1.Asymptomatic
2.Non-smoking (<10 packyears, quit >6 months)
3.Normal spirometry (FEV1, FVC, FEV1/FVC ratio: all >LLN)
4.FeNO < 25 ppb
5.Non-atopic based on skin-prick test
6.Negative mannitol provocation test
7.Younger (n=10, 18-45 years) and older (n=10, >45-75 years) subjects.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
1.Previous medical history or evidence of an uncontrolled intercurrent illness that in the opinion of the investigator may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject’s ability to participate in the study. Subjects with well-controlled comorbid disease (eg, hypertension, hyperlipidemia, gastroesophageal reflux disease) on a stable treatment regimen for 15 days prior to Visit 1 are eligible.
2.Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (e.g., cystic fibrosis, pulmonary fibrosis, moderate-severe bronchiectasis, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome, active tuberculosis). In addition for the different groups the following:
a.Patient with asthma: concomitant COPD.
b.Patients with COPD: concomitant asthma (former and current)
c.Healthy subjects: COPD and asthma.
3.Any clinically relevant abnormal findings in hematology or clinical chemistry (laboratory results from Visit 1), physical examination, vital signs during the screening, which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject’s ability to participate in the study.
4.Evidence of active liver disease, including jaundice or aspartate transaminase, alanine transaminase, or alkaline phosphatase >1.5 times the upper limit of normal (laboratory results from Visit 1).
5.GFR <30 ml/min.
6.Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 2 weeks prior to Visit 1, during the run-in period, or at Visit 2 (randomization).
7.A positive human immunodeficiency virus (HIV) test at screening or subject taking antiretroviral medications, as determined by medical history and/or subject’s verbal report.
8.History of sensitivity to any component of the investigational product formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor contraindicates their participation.
9.History of any known primary immunodeficiency disorder excluding asymptomatic selective immunoglobulin A or IgG subclass deficiency.
10.Receipt of any of the following within 30 days prior to Visit 1:
a.Immunoglobulin or blood products, or
b.Receipt of any investigational non-biologic agent within 30 days or 5 half-lives prior Visit 1, whichever is longer.
11.Pregnant, breastfeeding or lactating females
12.History of chronic alcohol or drug abuse within 12 months prior to Visit 1.
13.Planned surgical procedures requiring general anesthesia or in-patient status for > 1 day during the conduct of the study.
14.Unwillingness or inability to follow the procedures outlined in the protocol.
15.Concurrent enrollment in another clinical study involving an investigational treatment.
16.Receipt of any live or attenuated vaccines within 15 days prior to Visit 1.
17.Long QTc interval on ECG (QTc >480msec).
18.History of the following cardiac comorbidities:
a.Life-threatening arrhythmias
b.Myocardial infarction (NSTEMI or STEMI) less than 6 months before start of the study
c.Unstable angina
d.History of severe heart failure
19.Documented severe hypokalemia (K <3.0 mmol/L) or hypomagnesemia (Mg <0.5 mmol/L).
20.Life expectancy <6 months.
21.Hearing im
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method