AsthmaPhase 2NCT01130064
Efficacy of QAX576 in Asthma
A Phase 2 study testing QAX576 in people with Asthma, run by Novartis Pharmaceuticals at 52 sites in 7 countries.
Trial summary
The purpose of this study is to investigate the efficacy of 24 weeks intravenous treatment with QAX576 in patients with persistent asthma not adequately controlled with inhaled corticosteroids and long acting beta2-agonists. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- QAX576
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 259 participants
- Where
- 52 sitesin 7 countries
- Study dates
- May 2010to Apr 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients
- Female patients must be surgically sterilized or postmenopausal
- Male patients must use two forms of contraception
- Body mass index must be between 18 and 39 kg/m2
- Diagnosis of asthma for at least one year, which is not adequately controlled by inhaled corticosteroids and long acting beta-2 agonists
Who cannot join
- Smoking history >10 pack-years
- Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)
- Patients who have experienced a severe asthma attack/exacerbation requiring systemic corticosteroids or an increase in maintenance doses, within 6 weeks of screening
- Patients who have had a respiratory tract infection within 6 weeks prior to screening
- History of schistosomiasis, within 6 months of screening, or traveling to a country endemic with schistosomiasis within 6 months of completing the study
Trial locations and contacts
52 sites in 7 countries.
52 sites in 7 countries
United States10 sites
Novartis Investigative Site
Charleston, South Carolina, 29407
Novartis Investigative Site
Huntington Beach, California, 92647
Novartis Investigative Site
Las Vegas, Nevada, 89119
Novartis Investigative Site
Marion, Ohio, 43302
Novartis Investigative Site
Minneapolis, Minnesota, 55402
Novartis Investigative Site
Owensboro, Kentucky, 42301
Novartis Investigative Site
Phoenix, Arizona, 85006
Novartis Investigative Site
St Louis, Missouri, 63141
Novartis Investigative Site
Summerville, South Carolina, 29485
Novartis Investigative Site
Wheaton, Maryland, 20902
Argentina10 sites
Novartis Investigative Site
Buenos Aires, C1125ABE
Novartis Investigative Site
CABA, Buenos Aires, B8000XAV
Novartis Investigative Site
CABA, Buenos Aires, C1122AAK
Novartis Investigative Site
CABA, Buenos Aires, C1186ACB
Novartis Investigative Site
Mendoza, M5500FIK
Novartis Investigative Site
Rosario, Santa Fe Province, S2000CXH
Novartis Investigative Site
Rosario, Santa Fe Province, S2000DBS
Novartis Investigative Site
Rosario, Santa Fe Province, S2000DSV
Novartis Investigative Site
Rosario, Santa Fe Province, S2000JKR
Novartis Investigative Site
Santa Fe, S3000FIL
Germany9 sites
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Berlin, 14050
Novartis Investigative Site
Frankfurt, 60596
Novartis Investigative Site
Großhansdorf, 22947
Novartis Investigative Site
Kassel, 34121
Novartis Investigative Site
Leipzig, 04207
Novartis Investigative Site
Leipzig, 04357
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Rüdersdorf, 15562
Russia8 sites
Novartis Investigative Site
Barnaul, 656045
Novartis Investigative Site
Kazan', Tatarstan Republic, 420015
Novartis Investigative Site
Moscow, 105077
Novartis Investigative Site
Moscow, 115280
Novartis Investigative Site
Nizhny Novgorod, 603018
Novartis Investigative Site
Ryazan, 390026
Novartis Investigative Site
Samara, 443079
Novartis Investigative Site
Yaroslavl, 150003
Belgium6 sites
Novartis Investigative Site
Brussels, 1070
Novartis Investigative Site
Eupen, 4700
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
Laken, 1020
Novartis Investigative Site
Leuven, 3000
Novartis Investigative Site
Liège, 4000
Poland5 sites
Novartis Investigative Site
Bialystok, 15-010
Novartis Investigative Site
Gdansk, 80-211
Novartis Investigative Site
Lodz, 90-153
Novartis Investigative Site
Lublin, 20-89
Novartis Investigative Site
Poznan, 60-569
Czechia4 sites
Novartis Investigative Site
Rokycany, Czech Republic, 337 01
Novartis Investigative Site
Strakonice, Czech Republic, 38601
Novartis Investigative Site
Tábor, 390 01
Novartis Investigative Site
Teplice, CZE, 415 01
About this study
Official title: A Multi-center, Randomized, Double Blind, Placebo-controlled, 'add-on' Study to Investigate the Efficacy and Safety of 24 Weeks Intravenous Treatment With QAX576 in Patients (≥18-75 Years) With Persistent Asthma Not Adequately Controlled With Inhaled Corticosteroids and Long Acting β2-agonists
The purpose of this study is to investigate the efficacy of 24 weeks intravenous treatment with QAX576 in patients with persistent asthma not adequately controlled with inhaled corticosteroids and long acting beta2-agonists.
- Conditions
- Asthma
- Being tested
- QAX576, Placebo
- Keywords
- Asthma, QAX576
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QAX576Biological
every 3 weeks via intravenous infusion
PlaceboDrug
every 3 weeks via intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| QAX576 | Experimental | QAX576 Receives: Biological: QAX576 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Questionnaire
Measured: 24 weeks
Secondary outcomes (1)
Incidence rate of clinically significant asthma exacerbations
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2012
- Study completionApr 2012
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 259 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
- NCT01130064
- Sponsor's protocol ID
- CQAX576A2207
- Other IDs
- 2009-011590-32, 2009
- Status last verified
- Feb 2017
- First submitted
- 24 May 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 Multi-center, Randomized, Double Blind, Placebo-controlled, 'add-on' Study to Investigate the Efficacy and Safety of 24 Weeks Intravenous Treatment With QAX576 in Patients (≥18-75 Years) With Persistent Asthma Not Adequately Controlled With Inhaled Corticosteroids and Long Acting β2-agonists
- ClinicalTrials.gov ID
- NCT01130064
- Acronym / sponsor ID
- CQAX576A2207
- Conditions
- Asthma
- Keywords
- Asthma, QAX576
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 25 May 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.
The purpose of this study is to investigate the efficacy of 24 weeks intravenous treatment with QAX576 in patients with persistent asthma not adequately controlled with inhaled corticosteroids and long acting beta2-agonists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QAX576 | Experimental | Biological: QAX576QAX576 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients
- Female patients must be surgically sterilized or postmenopausal
- Male patients must use two forms of contraception
- Body mass index must be between 18 and 39 kg/m2
- Diagnosis of asthma for at least one year, which is not adequately controlled by inhaled corticosteroids and long acting beta-2 agonists
Key exclusion criteria (5 listed)
- Smoking history >10 pack-years
- Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)
- Patients who have experienced a severe asthma attack/exacerbation requiring systemic corticosteroids or an increase in maintenance doses, within 6 weeks of screening
- Patients who have had a respiratory tract infection within 6 weeks prior to screening
- History of schistosomiasis, within 6 months of screening, or traveling to a country endemic with schistosomiasis within 6 months of completing the study
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 |
|---|---|---|
| QAX576every 3 weeks via intravenous infusion | Biological | QAX576 |
| Placeboevery 3 weeks via intravenous infusion | Drug | Placebo |
Primary outcome
Asthma Control Questionnaire
Time frame: 24 weeks
1 secondary outcome
Incidence rate of clinically significant asthma exacerbations
Time frame: 24 weeks
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 19 Dec 2020.
- Results for CQAX576A2207 from 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
52 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QAX576 in people with Asthma, run by Novartis Pharmaceuticals at 52 sites in 7 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 5 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 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 52 sites in United States, Argentina, Germany, Russia, Belgium and 2 more countries. 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?
Asthma Control Questionnaire (time frame: 24 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 19 Dec 2020.