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Summary
EudraCT Number:2008-005168-15
Sponsor's Protocol Code Number:CQAV680A2201
National Competent Authority:Germany - BfArM
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2008-09-24
Trial results View results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedGermany - BfArM
A.2EudraCT number2008-005168-15
A.3Full title of the trial
A randomized, double-blind, two way cross-over, proof of concept study to compare the efficacy, safety, pharmacokinetics and pharmacodynamics of two-week oral administration of QAV680 versus placebo, with an extended open-label inhaled corticosteroid period, in steroid-free, mild to moderate persistent asthma patients
A.4.1Sponsor's protocol code numberCQAV680A2201
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorNovartis Pharma Services AG
B.1.3.4CountrySwitzerland
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.2Product code QAV680
D.3.4Pharmaceutical form Capsule, hard
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2Current sponsor codeQAV680
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number100
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 2
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Flutide® mite 100 Diskus
D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline GmbH & Co. KG
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameFlutide mite 100 Diskus
D.3.4Pharmaceutical form Inhalation powder
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPInhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNFluticasone propionate
D.3.9.1CAS number 80474-14-2
D.3.10 Strength
D.3.10.1Concentration unit µg microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number100
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboCapsule, hard
D.8.4Route of administration of the placeboOral use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Mild to moderate persistent asthma, steroid-free patients
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 9.1
E.1.2Level LLT
E.1.2Classification code 10003553
E.1.2Term Asthma
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
• To assess the efficacy and safety of multiple doses of QAV680 (500 mg BID over 14 days) compared to placebo in mild to moderate persistent steroid free asthma patients
E.2.2Secondary objectives of the trial
• To assess the pharmacokinetics of multiple doses of QAV680 in asthma patients.

• To assess the pharmacodynamic effect of multiple doses of QAV680 on exhaled NO in asthma patients.

• To assess the effect of QAV680 on asthma control using assessments such as Asthma Control Questionnaire (ACQ) score, FEV1 variability data captured by PIKO-1 home monitoring device and the extent of inhaled salbutamol use as rescue medication.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
1. Male and female patients aged 18 to 65 years with symptomatic mild to moderate persistent asthma for ≥ 6 months
2. Patients should be steroid naive or off steroids and chromoglycate (by any route) for at least 4 weeks before randomisation. Only use of short-acting β2-agonists is permissible as rescue medication.
3. Patients should have pre-bronchodilator FEV1 ≥60% predicted with ≥12% or 200 mL improvement post short acting β2-agonist (200µg inhaled Salbutamol).
• Patients who are NOT on ICS during screening need to demonstrate reversibility during screening visit
• Patients who are on steroids need to demonstrate reversibility during the first baseline AFTER their steroid-withdrawal
4. Women must be postmenopausal or surgically sterilized at the time of participation as defined in the protocol.
5. Male subjects must be using a two acceptable methods of contraception as defined in the protocol up to the Study Completion visit and refrain from fathering a child in the 3 months following the last study drug administration.
6. Subjects must weigh at least 45 kg and have a body mass index (BMI) within the range of 20 to 30 kg/m2.
7. Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
E.4Principal exclusion criteria
1. Smokers (defined as history of smoking in the previous 2 months)
2. Use of any prescription drugs, herbal supplements, within 4 weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within 2 weeks prior to initial dosing other than short acting inhaled beta-agonists and paracetamol is acceptable but must be documented in the Concomitant CRF.
3. Participation in any clinical investigation within 4 weeks prior to initial dosing.
4. Donation or loss of 400 ml or more of blood within 8) weeks prior to initial dosing. Hemoglobin levels below 12.0 g/dl at screening.
5. Significant illness within 2 weeks prior to initial dosing.
6. Patients with positive stool examination at screening for helminthic, ova or parasitic infections.
7. Past medical history of clinically significant ECG abnormalities, or recent history of hypertension or autonomic dysfunction
8. Recent history (within past three months) of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures.
9. Use of theophylline or long acting β2 agonists in the last 2 weeks prior to dosing
10. Pregnant or lactating women.
11. Any disease or illness, other than asthma, that may require the use of systemic corticosteroids during the study period.
12. Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication. Patients with other serious underlying diseases as defined in protocol.
13. History of multiple allergies to drugs or allergy to the investigational compound/compound class being used in this study.
17. Vulnerable patients (e.g. patients kept in detention)

---REFER TO STUDY PROTOCOL FOR FULL LIST OF EXCLUSION CRITERIA---
E.5 End points
E.5.1Primary end point(s)
Trough FEV1 on Day 15 of each treatment period
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy No
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic Yes
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic Yes
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open No
E.8.1.3Single blind No
E.8.1.4Double blind Yes
E.8.1.5Parallel group No
E.8.1.6Cross over Yes
E.8.1.7Other Yes
E.8.1.7.1Other trial design description
Third period with open-label fluticasone propionate
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Yes
E.8.2.2Placebo Yes
E.8.2.3Other No
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.4.1Number of sites anticipated in Member State concerned2
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
E.8.7Trial has a data monitoring committee No
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years0
E.8.9.1In the Member State concerned months8
E.8.9.1In the Member State concerned days15
E.8.9.2In all countries concerned by the trial years0
E.8.9.2In all countries concerned by the trial months8
E.8.9.2In all countries concerned by the trial days15
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations No
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception No
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state20
F.4.2 For a multinational trial
F.4.2.2In the whole clinical trial 50
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
Steroid naive patients who would benefit from the fluticasone treatment in the trial will be referred to their primary care doctor for evaluation to continue it. See section 4 page 31 of protocol.
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2008-12-15
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2009-10-07

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