A randomized, double-blind, parallel group study to compare the pharmacodynamics/efficacy, safety and pharmacokinetics of QAV680 versus placebo in patients with moderate persistent asthma

• Conditions: Moderate persistent asthma; MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2009-017267-41-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-09
• Last Update Posted: 17 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1. Healthy male and female asthma patients 18 to 65 years of age included.

2. Patients with atopic moderate persistent asthma, diagnosed according to GINA
guidelines 2008 (see protocol for full details)
• atopic as confirmed by a positive skin prick test at screening to allergen
• gradually tapered down on inhaled steroids for at least 28 days
or washed off any other asthma medication before randomization. Patients may be allowed to enter the study on a stable fraction of the original dose of steroids if they meet all other inclusion criteria. Use of short-acting ß2-agonists is permissible as rescue medication.
• FEV1 of = 60% and = 90% of the predicted normal value at Baseline after the placebo run-in period are completed
• increase of =12% AND 200mL in FEV1 over pre-bronchodilator value within 30 minutes after inhaling 400µg of Salbutamol MDI (or equivalent dose): reversibility
• symptomatic everyday at Baseline (after steroid and/or LABA Washout)

3. Women must be post menopausal or surgically sterilized at the time of participation (see protocol for full details).

4. Male patients must be using a two acceptable methods of contraception, (e.g.,
spermicidal gel plus condom) for the entire duration of the study, up to the Study
Completion visit, and refrain from fathering a child in the three months following the
last study drug administration. Periodic abstinence and withdrawal are not acceptable methods of contraception.

5. Patients must weigh at least 45 kg to participate in the study, and must have a body mass index (BMI) of >20 kg/m2.

6. Able to communicate well with the Investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
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

1. Pregnant or lactating women.
2. Smokers (history of smoking in previous 6 months or more than 10 pack years)
3. Use of any prescription drugs, herbal supplements, within 28 days prior to initial
dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins
included) within 14 days prior to initial dosing other than short acting inhaled beta-agonists and paracetamol for the treatment of minor ailments e.g. headache from 48hr before the first dose until the end of study visit is acceptable, but must be documented in the Concomitant medications / Significant non-drug therapies page of the CRF.
4. Participation in any clinical investigation within 28 days prior to initial dosing, or
within 10 times the corresponding half-life of the drug taken whichever is longer.
5. Donation or loss of 400ml or more of blood within 56 days prior to initial dosing, or
longer if required by local regulation. Haemoglobin levels below normal range at
screening.
6. Significant illness within 14 days prior to initial dosing.
7. A past medical history of clinically significant ECG abnormalities, or recent history of
autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc).
8. History of life-threatening asthma, defined as an asthma episode that required
intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures. History of asthma exacerbation in the past 6 months that required
hospitalization or emergency unit visit.
9. Use of a biologic (e.g., monoclonal antibodies) agent or oral corticosteroids for the
treatment of asthma in the past 4 months.
10. Any disease or illness, other than asthma, that may require the use of systemic
corticosteroids during the study period.
11. Any occupational exposure to allergens/ irritants that may have a potential to worsen the asthma symptoms during the study.
12. Respiratory tract infection and/or exacerbation of asthma within 28 days prior to the first dose of study medication. Patients with other serious underlying diseases (i.e. tuberculosis, bronchiectasis, pulmonary fibrosis, pulmonary hypertension, emphysema, chronic bronchitis, a-1-antitrypsin deficiency).
---REFER TO STUDY PROTOCOL FOR FULL LIST OF EXCLUSION CRITERIA---

Study & Design

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