Efficacy and safety of AVT-01 5 mg once daily over 7 days in patients with moderate persistent atopic asthma – A double-blind, randomized, placebo-controlled clinical study
- Conditions
- Male outpatients aged 18 - 65 with moderate persistent atopic asthmaMedDRA version: 8.1Level: LLTClassification code 10003638Term: Atopic asthma
- Registration Number
- EUCTR2006-004187-32-GB
- Lead Sponsor
- Avontec GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 48
- Written informed consent by the patient for study participation, prior to protocol specific procedures·
- Male outpatients aged 18 - 65·
- Atopic asthma defined as:
The patients have to suffer from allergic complaints caused by clinically relevant sensitisation against house dust mites. The IgE mediated sensitisation has to be verified by:
suggestive medical history;
a positive skin prick test for house dust mites, resulting in a wheal diameter of at least 3 mm > negative control reaction;
or '++' versus histamine
Patients with co-allergies (e.g. trees, grasses) may only be included before or after the respective pollen season
- Moderate persistent asthma acc. GINA classification 2005:
FEV1 = 60 to 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
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
- NSAIDs
- Immunosuppressant agents
- Antihistamines
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 acido
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
- Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study
- Patients who have difficulties in understanding the language in which the patient information is given
- Any vulnerable patient (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)
- 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).
- Patients in custody by juridical or official order
- Evidence of an uncooperative attitude
- A patient who is at the same time the investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary variable:·Calculated methacholine PC20 doubling concentration difference on day 7 compared to day 0;Secondary Objective: Secondary variables:<br>Spirometry (FEV1, FVC)<br>Calculated methacholine PC20 doubling concentration difference on day 3 compared to day 0<br>Adverse Events<br>Safety lab;Primary end point(s): The primary endpoint will be the calculated PC20 doubling concentration difference on day 7 compared to day 0. <br><br>Comparison between the treatment groups will be done using a two-sided t-test at the 5% level. If a normal distribution cannot be assumed then a Wilcoxon rank-sum test will be performed (two-sided, 5% level).<br><br>The primary population for analysis will be the ITT-KPA population.<br>
- Secondary Outcome Measures
Name Time Method