Pseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of life

Phase 1

Conditions: Chronic pulmonary disease patients, except cystic fibrosis patients, with confirmed pulmonary infection by sputum sample positive for Pseudomonas Aeruginosa.
MedDRA version: 18.1Level: LLTClassification code 10051190Term: Pneumonia Pseudomonas aeruginosaSystem Organ Class: 100000004862
MedDRA version: 18.1Level: LLTClassification code 10050700Term: Chronic respiratory disease NOSSystem Organ Class: 100000004855
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2015-003662-87-DK

Lead Sponsor: Aarhus University Hospital, Department of Respiratory Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

In order to be eligible to participate in this study, the patient must meet all of the following criteria:
·Signed informed consent to participate in the study in accordance with local
regulations
·Diagnosed with a chronic pulmonary disease by lung functions test or CT
·Diagnosed with one positive sputum sample with PA during the last year
·Age 18 - 85 years inclusive
·Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study
procedures specified in the protocol.

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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
·Prophylactic treatment with any other antibiotic
·Allergy to tazocin, ciprofloxacin or colistimethate-sodium
·Patients who are pregnant or planning a pregnancy
·Patients with any solid organ transplant
·Patients with cystic fibrosis
·Patients on assisted ventilation
·Bronchiectasis as a consequence of cystic fibrosis or focal endobronchial
lesion or otherwise curable causes (e.g. foreign body aspiration)
·Be considered terminally ill or listed for transplantation
·Actively treated Mycobacterium tuberculosis or other mycobacteria
·Patients in a condition or in a situation, which in the investigator's opinion
may put the subject at significant risk, may confound results or may interfere
significantly with the patient's participation in the study