Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
40–60
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Male or female healthy subjects or COPD (GOLD I to III) outpatients with or without A1AT deficiency
Ex-smokers for at least 9 months with a smoking history of \>=20 pack years
Signed informed consent consistent with ICH-GCP (International Conference on Harmonisation - Good Clinical Practice) guidelines prior to participation in the study, which includes the application of study restrictions
Age \>= 40 and \<=70 years
Body mass index (BMI) of \>= 18 and \<= 35 kg/m2 (\<= 30 kg/m2 in the MRI subset)
Ability to perform all study related procedures including technically acceptable pulmonary function tests, body plethysmography, DLCO ( Diffusing Capacity of the lungs for Carbon Monoxide) , sputum induction (if applicable), chest CT (Computed Tomography) and MRI (if applicable)
The current COPD must be mild, moderate or severe based on lung functions and symptoms and the clinical situation must have stabilized for at least 4 weeks prior to Visit 1. The following definitions adapted from the GOLD Guidelines apply:
1. mild: post-broncho-dilator FEV1 \>=80% of predicted normal (GLI 2012 and JRS 2014) at Visit 1
2. moderate: 50%\<= post-broncho-dilator FEV1 \< 80% of predicted normal (GLI 2012 and JRS 2014) without chronic respiratory failure at Visit 1
3. severe: 30%\<= post-bronchodilator FEV1 \<50% of predicted normal (GLI 2012 and JRS 2014) without chronic respiratory failure at Visit 1
Patients must be on stable therapy (not limited to respiratory medication) for the last 4 weeks prior to Visit 1
\- Documented A1AT deficiency of ZZ genotype
Normal lung function values at Visit 1 with a documented post-bronchodilator FEV1 \>=80% of predicted normal (GLI 2012 and JRS 2014) and a post-bronchodilator FEV1/FVC \>= lower limit of normal
Mean post DLCO over all acceptable measurements at Visit 1 of \>= 70% of predicted normal
You may not be if
Previous participation in this study or participation in another trial with an investigational drug within 6 weeks prior to Visit 1 or during the study
Significant pulmonary disease or other significant medical conditions\* (as determined by medical history, examination and clinical investigations at screening) that may in the opinion of the investigator result in any of the following:
1. Put the subject at risk because of participation in the study
2. Cause concern regarding the subject's ability to participate in this study \*e.g. rheumatoid arthritis, inflammatory bowel disease, severe liver disease, psoriasis, hematological, infectious and psychiatric diseases
Documented history of asthma. For allergic rhinitis or atopy, source documentation to verify that the subject does not have asthma
Planned surgery during the study expected to interfere with study procedures and outcome
Blood withdrawal of more than 100 mL within the past 6 weeks prior to Visit 1 and between Visit 1 and 2
Significant alcohol or drug abuse within past 2 years prior to Visit 1
Women who are pregnant, nursing or plan to become pregnant while in the study
Place of permanent residence of less than 3 months prior to Visit 1
For the MRI subset: subject who do not meet the following criteria for the MRI assessment at Visit 2: systolic blood pressure between 90 and 180 mmHg (SBP), diastolic blood pressure between 50 and 110 mmHg (DBP), pulse rate between 40 and 110 bpm, ear temperature between 35 - 37.5 C, and a glomerular filtration rate (GFR) \>= 30 mL/min (GFR must not be older than 14 days from the MRI assessment)
\- Respiratory tract infection or COPD exacerbation in the 4 weeks prior to Visit 1 or during the screening period prior to Visit 2, if rescheduling rules cannot be met
Newly added anti-inflammatory treatment within 4 weeks prior to Visit 1
Patients on treatment with PDE (Phosphodiesterase)-5 inhibitors (e.g. Roflumilast) and maintenance treatment Methylxanthines (e.g. Theophylline)
Hospitalisation for respiratory failure during the year prior to Visit 1
A history of cystic fibrosis
Clinical diagnosis of bronchiectasis requiring specific treatment
Clinically relevant abnormal baseline hematology and blood chemistry
Known active tuberculosis
Patients with change in any therapy within 4 weeks prior to Visit 1
Current and planned A1AT augmentation therapy
A malignancy for which the patient has undergone resection, radiation or chemotherapy within past 5 years. Patients with treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed
Inability to comply with restrictions regarding diet, life style and medication
Clareo Health | Longitudinal Follow up to Assess Biomarkers Predictive of Emphysema Progression in Patients With COPD (Chronic Obstructive Pulmonary Disease)
