AsthmaPhase 2NCT01103037
Efficacy, Safety and Pharmacokinetics of QAV680 Versus Placebo in Patients With Asthma
A Phase 2 study testing QAV680 in people with Asthma, run by Novartis Pharmaceuticals at 7 sites in 3 countries.
Trial summary
This study will assess the safety and efficacy of QAV680 in patients with mild to moderate 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Mar 2010to Sep 2010
- 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
- Patients with moderate persistent asthma
Who cannot join
- Smokers
- Any significant disease or illness, other than asthma
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States3 sites
American Health Research
Charlotte, North Carolina, 28207
West Coast Clinical Trials
Cypress, California, 90630
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Germany3 sites
Novartis Investigative Site
Berlin
Novartis Investigative Site
Hamburg
Novartis Investigative Site
Wiesbaden
About this study
Official title: 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
This study will assess the safety and efficacy of QAV680 in patients with mild to moderate asthma
- Conditions
- Asthma
- Being tested
- QAV680, QAV680 Placebo
- Keywords
- Mild, Moderate, Asthma
- Medical subject headings
- Asthma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QAV680Drug
QAV680 500 mg (5 x 100 mg capsules) four times per day
QAV680 PlaceboDrug
Placebo to QAV680 5 capsules four times per day
| Study group | Role | What they receive |
|---|---|---|
| QAV680 | Experimental | Not described Receives: Drug: QAV680 |
| QAV680 Placebo | Placebo comparator | Not described Receives: Drug: QAV680 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry
Measured: 28 days
Secondary outcomes (5)
FEV1 assessments at various timepoints including time of peak drug concentration
Measured: 28 days
Measure the change in exhaled Nitric Oxide (FeNO)
Measured: 28 days
Assessment of the pharmacokinetics of multiple doses of QAV680 in patients with mild to moderate asthma.
Measured: 28 days
Total serum IgE levels
Measured: 28 days
Change in daily variability in the morning and evening Peak Expiratory Flow Rate (PEFR) from Baseline.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Terminated by sponsor
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.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103037
- Sponsor's protocol ID
- CQAV680A2201E1
- Other IDs
- 2009-017267-41, 2009
- Status last verified
- May 2012
- First submitted
- 12 Apr 2010
- Last updated
- 19 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01103037
- Acronym / sponsor ID
- CQAV680A2201E1
- Conditions
- Asthma
- Keywords
- Mild, Moderate, Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated by sponsor
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 13 Apr 2010 (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 will assess the safety and efficacy of QAV680 in patients with mild to moderate asthma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QAV680 | Experimental | Drug: QAV680 |
| QAV680 Placebo | Placebo comparator | Drug: QAV680 Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with moderate persistent asthma
Key exclusion criteria (3 listed)
- Smokers
- Any significant disease or illness, other than asthma
- 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 |
|---|---|---|
| QAV680QAV680 500 mg (5 x 100 mg capsules) four times per day | Drug | QAV680 |
| QAV680 PlaceboPlacebo to QAV680 5 capsules four times per day | Drug | QAV680 Placebo |
Primary outcome
Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry
Time frame: 28 days
5 secondary outcomes
FEV1 assessments at various timepoints including time of peak drug concentration
Time frame: 28 days
Measure the change in exhaled Nitric Oxide (FeNO)
Time frame: 28 days
Assessment of the pharmacokinetics of multiple doses of QAV680 in patients with mild to moderate asthma.
Time frame: 28 days
Total serum IgE levels
Time frame: 28 days
Change in daily variability in the morning and evening Peak Expiratory Flow Rate (PEFR) from Baseline.
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Terminated by sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Results for CQAV680A2201E1 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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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 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QAV680 in people with Asthma, run by Novartis Pharmaceuticals at 7 sites in 3 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 3 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: stopped early, as of the sponsor's last update on 19 Dec 2020. 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 United States, Germany, Russia. 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 was stopped early (reason given: Terminated by sponsor). Results are not available in the source record.
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?
Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry (time frame: 28 days). 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 19 Dec 2020.