Influence of inhaled Aviptadil on CCL18 serum concentrations in patients with pulmonary fibrosis - Inhaled Aviptadil in pulmonary fibrosis

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-002174-22-DE
• Date of registration: 23/08/2006
• Prospective Registration: Yes
• Primary sponsor: Mondobiotech Laboratories Anstalt
• Public title: Influence of inhaled Aviptadil on CCL18 serum concentrations in patients with pulmonary fibrosis - Inhaled Aviptadil in pulmonary fibrosis
• Scientific title: Influence of inhaled Aviptadil on CCL18 serum concentrations in patients with pulmonary fibrosis - Inhaled Aviptadil in pulmonary fibrosis
• Date of first enrolment: 08/11/2006
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002174-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
?Diagnosis: clinically active pulmonary fibrosis, based on clinical history, and lung biopsy, consistent with a histologic pattern of UIP or NSIP or a mixture of both. In addtion, the diagnosis IPF/UIP will also be accepted on the basis of the diagnostic criteria of the ATS/ERS consensus statement.
?Aged above 18 years
?Written consent
?Highly effective contraception in female patients of childbearing age
?Negative pregnancy test

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

Exclusion criteria:
?Lack of consent
?Pregnancy and lactation
?Presumed non-cooperativeness
?Malignant diseases in anamnesis
?Legal incapacity
?Parallel participation in another clinical trial or participation in any other trial within the previous 30 days
?Clinical instability in form of general symptoms of fibrosis such as fever (= 38oC), fatigue or weakness or hypoxemia under oxygen supplementation (= 60 mmHg oxygen, international standards exclude patients with =55mmHg).
?Respiratory insufficiency identified by hypoxemia (PaO2 = 50 mmHg breathing room air) and/or reduction of vital capacity to less or equal of 40% predicted
?Allergy or hypersensitivity against Aviptadil or any other compound present in the aerosol to be inhaled



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Pulmonary Fibrosis categorized as UIP or NSIP

Intervention(s)

Product Name: Aviptadil, 66 microgram/mL
Pharmaceutical Form: Inhalation vapour, solution
CAS Number: 40077-57-4
Other descriptive name: Vasoactive intestinal peptide
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 66.6-
Pharmaceutical form of the placebo: Inhalation vapour, solution
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

Secondary Objective: Influence of inhaled Aviptadil on TNF-a concentration in BAL- cell culture supernatant
Influence of inhaled Aviptadil on pulmonary compliance.
Influence of inhaled Aviptadil on volumes of bodyplethysmography (residual volume, vital capacity, total lung capacity)
Influence of inhaled Aviptadil on the quality of life as recorded in appropriate questionnaire forms (SF36, St. George’s Respiratory Questionnaire)
6-minutes walking test

Primary end point(s): Decrease of the plasma concentration of CCL-18 in patients with Pulmonary Fibrosis

Main Objective: Influence of inhaled Aviptadil on CCL18 serum concentrations in patients with pulmonary fibrosis

Secondary ID(s)

Avifibro