AsthmaPhase 2NCT00814216
Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients
A Phase 2 study testing QAV680 and Fluticasone Propionate in people with Asthma, run by Novartis at 7 sites in 2 countries.
Trial summary
This study aims to study the efficacy (as measured by change in FEV1) and safety of two-week administration of oral QAV680 in the treatment of patients with asthma.' Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- QAV680 and Fluticasone Propionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Dec 2008to Oct 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate persistent asthma for at least 6 months.
Who cannot join
- Past or recent history of significant medical illness and/or lab abnormalities including but not limited to ECG abnormalities, abnormal LFT, HIV, Hep B/C,
- Allergic disorders, pancreatic disease, serious underlying respiratory diseases, life threatening asthma, renal disease etc
- Surgical and/or medical conditions which significantly effect ADME of the drug.
- Prior use of asthma medications (except SABA's) prior to 2 weeks of dosing
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
India4 sites
Novartis Investigative Site
Ahmedabad
Novartis Investigative Site
Mumbai
Novartis Investigative Site
Mysore
Novartis Investigative SIte
Nagpur
Germany3 sites
Novartis Investigative Site
Berlin
Novartis Investigative Site
Munich
Novartis Investigative Site
Wiesbaden
About this study
Official title: Randomized, Double-blind, Two Way Cross-over, Proof of Concept Study to Compare Efficacy, Safety, Pharmacokinetics & Pharmacodynamics of QAV680 Versus Placebo, With an Extended Open-label Corticosteroid Period, in Steroid-free, Mild to Moderate Persistent Asthma Patients.
This study aims to study the efficacy (as measured by change in FEV1) and safety of two-week administration of oral QAV680 in the treatment of patients with asthma.'
- Conditions
- Asthma
- Being tested
- QAV680, Matching placebo for QAV680, Fluticasone Propionate
- Keywords
- Efficacy, safety, QAV680, pharmacokinetics, corticosteroid, asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QAV680Drug
Matching placebo for QAV680Drug
Fluticasone PropionateDrug
| Study group | Role | What they receive |
|---|---|---|
| QAV680 | Experimental | Not described Receives: Drug: QAV680 |
| Placebo | Placebo comparator | Not described Receives: Drug: Matching placebo for QAV680 |
| Fluticasone Propionate Inhaler | Active comparator | Not described Receives: Drug: Fluticasone Propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry.
Measured: 2 weeks
Secondary outcomes (4)
Measure: Change in Asthma Control Questionnaire (ACQ) score
Measured: 2 weeks
Measure: Frequency of salbutamol usage
Measured: 2 weeks
Measure: Change in exhaled Nitric Oxide (NO)
Measured: 2 weeks
Home Monitoring Of FEV1 By PIKO Monitors
Measured: Day 2 to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814216
- Sponsor's protocol ID
- CQAV680A2201
- Other IDs
- EudraCT number: 2008-005168-15
- Status last verified
- Feb 2017
- First submitted
- 23 Dec 2008
- Last updated
- 8 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Two Way Cross-over, Proof of Concept Study to Compare Efficacy, Safety, Pharmacokinetics & Pharmacodynamics of QAV680 Versus Placebo, With an Extended Open-label Corticosteroid Period, in Steroid-free, Mild to Moderate Persistent Asthma Patients.
- ClinicalTrials.gov ID
- NCT00814216
- Acronym / sponsor ID
- CQAV680A2201
- Conditions
- Asthma
- Keywords
- Efficacy, safety, QAV680, pharmacokinetics, corticosteroid, asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Oct 2009 (actual)
- First posted
- 24 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to study the efficacy (as measured by change in FEV1) and safety of two-week administration of oral QAV680 in the treatment of patients with asthma.'
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QAV680 | Experimental | Drug: QAV680 |
| Placebo | Placebo comparator | Drug: Matching placebo for QAV680 |
| Fluticasone Propionate Inhaler | Active comparator | Drug: Fluticasone Propionate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mild to moderate persistent asthma for at least 6 months.
Key exclusion criteria (5 listed)
- Past or recent history of significant medical illness and/or lab abnormalities including but not limited to ECG abnormalities, abnormal LFT, HIV, Hep B/C,
- Allergic disorders, pancreatic disease, serious underlying respiratory diseases, life threatening asthma, renal disease etc
- Surgical and/or medical conditions which significantly effect ADME of the drug.
- Prior use of asthma medications (except SABA's) prior to 2 weeks of dosing
- Other protocol-defined inclusion/exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QAV680 | Drug | QAV680 |
| Matching placebo for QAV680 | Drug | Placebo |
| Fluticasone Propionate | Drug | Fluticasone Propionate Inhaler |
Primary outcome
Measure: Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry.
Time frame: 2 weeks
4 secondary outcomes
Measure: Change in Asthma Control Questionnaire (ACQ) score
Time frame: 2 weeks
Measure: Frequency of salbutamol usage
Time frame: 2 weeks
Measure: Change in exhaled Nitric Oxide (NO)
Time frame: 2 weeks
Home Monitoring Of FEV1 By PIKO Monitors
Time frame: Day 2 to Day 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QAV680 and Fluticasone Propionate in people with Asthma, run by Novartis at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in India, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure: Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.