Efficacy and safety of AVT-01 10 mg single dose in patients with mild asthma challenged with inhaled tumor necrosis factor alpha – A double-blind, randomized, placebo-controlled clinical study

• Conditions: Male outpatients aged 18 - 65 with moderate persistent atopic asthma; MedDRA version: 8.1Level: LLTClassification code 10003638Term: Atopic asthma

• Registration Number: EUCTR2006-004191-13-GB
• Lead Sponsor: Avontec GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

- Written informed consent by the patient for study participation, prior to protocol specific procedures
- Male outpatients aged 18 - 65
- Atopic persistent asthma defined as:
The patients have to suffer from allergic complaints caused by clinically relevant sensitisation against at least one common aeroallergen. The IgE mediated sensitisation has to be verified by:
suggestive medical history;
a positive skin prick test for the respective aeroallergen, resulting in a wheal diameter of at least 3 mm > negative control reaction;
or '++' versus histamine
- Mild persistent asthma acc. GINA classification 2005:
FEV1 = 80% predicted
PC20 methacholine = 4 mg / ml
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Intake of any of the following medications within the last 2 weeks prior to screening:
- Systemic antibiotics
- Systemic or inhaled glucocorticosteroids
- Systemic or inhaled long-acting beta-agonists
- Leukotriene modifiers
- Nedocromil

Intake of any of the following medications during the entire study:
- Systemic antibiotics
- Systemic or inhaled glucocorticosteroids
- Systemic or inhaled long-acting beta-agonists
- Leukotriene modifiers
- Nedocromil
- Cromolyn sodium
- Antihistamines
- NSAIDs
- Immunosuppressant agents
- Antitussive drugs (e.g. codeine or other morphine derivatives)

Medical history or presence of any of the following organic diseases:
- Acute respiratory infection (including common cold”) in the past 4 weeks prior to screening and during the entire study
- Chronic obstructive pulmonary disease (COPD)
- Acute episode of COPD
- Clinically relevant chronic cardiovascular disease
- Chronic kidney disease
- Gastrointestinal or liver diseases, such as:
active peptic gastric ulcer
malabsorption
hypersecretion of bile acid
hepatitis
- Malignant growth
- Severe somatopathic, neurological and/or psychiatric disease
- Aortic aneurysm
- Myasthenia gravis

General:
- Parallel participation in another study, participation in a study within less than 6 weeks prior to study entry, or previous participation in this same study
- Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, history of or [and] known drug abuse, known to be non-compliant or presenting an unstable psychiatric history)
- Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study
- Patients in custody by juridical or official order
- Evidence of an uncooperative attitude
- Patients who have difficulties in understanding the language in which the patient information is given
- A patient who is at the same time the investigator
- Any vulnerable subject (patient who is or could be dependent on the investigator, e.g. spouse of the investigator, nurses, members of the site staff, persons who are officially/legally admitted to an institution, persons with a terminal illness, persons
living in a nursing home, homeless persons, patients in emergency situations, prisoners, persons incapable of consenting)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified