AsthmaPhase 1/2NCT00940160
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QAX576 in Asthma Patients
A Phase 1/2 study testing QAX576 in people with Asthma, run by Novartis Pharmaceuticals at 3 sites in 2 countries.
Trial summary
This study is designed to investigate the safety and tolerability of multiple doses of QAX576 in controlled or partially controlled asthma patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- QAX576
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jul 2009to Jan 2010
- Phase
- Phase 1/2
- 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
- Non-smoking male and female subjects age 18 to 65 years, inclusive; with controlled or partially controlled asthma who are otherwise healthy as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. Female subjects are allowed to participate in this study if they are postmenopausal or surgically sterilized.
- Controlled or partially controlled asthma as defined in GINA 2007.
- At Screening, and Baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed after the subject has rested for at least three (3) minutes.
- Female subjects must be post-menopausal as confirmed by FSH ≥ 40, or have been surgically sterilized at least 6 months prior to screening.
- Subjects must have a body mass index (BMI) within the range of 18 to 30 kg/m2.
- Male subjects must be using two methods of contraception, i.e., spermicidal gel plus condom, for the entire duration of the study, up to Study Completion visit, and refrain from fathering a child in the six (6) months after study completion
Who cannot join
- Smokers (use of tobacco products in the previous 3 months).
- Use of any prescription drugs other than stable (4 weeks) use of hormone replacement or thyroid replacement within four (4) weeks prior to dosing (other than medication required for treatment of asthma).
- Use of any over the counter (OTC) medication within forty eight (48) hours prior to dosing.
- Use of oral steroids within 12 weeks prior to dosing.
- Patients who have received an investigational drug in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- Any immunotherapy with systemic biologics as a treatment therapy or during a clinical study with in the last 6 months.
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- Any immunotherapy with subcutaneous injections for allergy (allergy shots), within 3 months.
- Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
- Patients suffering from hay fever at screening or likely to require treatment during the study.
- History of chronic respiratory disease other than asthma or chronic allergic rhinitis.
- Hospitalization for asthma in the last year.
- History of intubation/assisted ventilation for asthma in the last 5 years.
- History of autonomic dysfunction (e.g. history of fainting, orthostatic hypotension).
- History or presence of any surgical or medical condition or clinically significant abnormal laboratory findings, which, in the opinion of the investigator, may jeopardize the subject in case of participation in the study.
- History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
- History of clinical schistosomiasis or travel within the preceding 6 months to an area with endemic schistosomiasis, including but not limited to Southeast Asia and Northwest Africa.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Russia2 sites
Novartis Investigator Site
Moscow
Novartis Investigator Site
Saint Petersburg
About this study
Official title: A Randomized, Double Blind, Placebo Controlled, Study To Compare The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Doses Of Intravenous Administration Of QAX576 In Controlled Or Partially Controlled Asthma Patients
This study is designed to investigate the safety and tolerability of multiple doses of QAX576 in controlled or partially controlled asthma patients.
- Conditions
- Asthma
- Being tested
- QAX576, Placebo
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QAX576Drug
QAX576Drug
QAX576Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| QAX576 1 mg/kg | Active comparator | Not described Receives: Drug: QAX576 |
| QAX576 3 mg/kg | Active comparator | Not described Receives: Drug: QAX576 |
| QAX576 10 mg/kg | Active comparator | Not described Receives: Drug: QAX576 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Assessing and comparing the safety and tolerability of multiple doses of QAX576 in controlled and partially controlled asthma patients.
Measured: 120 Days
Secondary outcomes (2)
Assessing the pharmacokinetics of multiple doses of QAX576 in asthmatics
Measured: 120 Days
Assessing the effect of QAX576 on asthma control using assessments such as exhaled NO, FEV1 variability data captures by PIKO-1 home monitoring device and the extent of inhaled salbutamol use as rescue medication.
Measured: 120 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2010
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940160
- Sponsor's protocol ID
- CQAX576A2107
- Status last verified
- Jan 2010
- First submitted
- 14 Jul 2009
- Last updated
- 21 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Study To Compare The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Doses Of Intravenous Administration Of QAX576 In Controlled Or Partially Controlled Asthma Patients
- ClinicalTrials.gov ID
- NCT00940160
- Acronym / sponsor ID
- CQAX576A2107
- Conditions
- Asthma
- Keywords
- Asthma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jan 2010 (actual)
- First posted
- 15 Jul 2009 (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 is designed to investigate the safety and tolerability of multiple doses of QAX576 in controlled or partially controlled asthma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| QAX576 1 mg/kg | Active comparator | Drug: QAX576 |
| QAX576 3 mg/kg | Active comparator | Drug: QAX576 |
| QAX576 10 mg/kg | Active comparator | Drug: QAX576 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Non-smoking male and female subjects age 18 to 65 years, inclusive; with controlled or partially controlled asthma who are otherwise healthy as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. Female subjects are allowed to participate in this study if they are postmenopausal or surgically sterilized.
- Controlled or partially controlled asthma as defined in GINA 2007.
- At Screening, and Baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed after the subject has rested for at least three (3) minutes.
- Female subjects must be post-menopausal as confirmed by FSH ≥ 40, or have been surgically sterilized at least 6 months prior to screening.
- Subjects must have a body mass index (BMI) within the range of 18 to 30 kg/m2.
Key exclusion criteria (16 listed)
- Smokers (use of tobacco products in the previous 3 months).
- Use of any prescription drugs other than stable (4 weeks) use of hormone replacement or thyroid replacement within four (4) weeks prior to dosing (other than medication required for treatment of asthma).
- Use of any over the counter (OTC) medication within forty eight (48) hours prior to dosing.
- Use of oral steroids within 12 weeks prior to dosing.
- Patients who have received an investigational drug in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
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 |
|---|---|---|
| QAX576 | Drug | QAX576 1 mg/kg |
| QAX576 | Drug | QAX576 3 mg/kg |
| QAX576 | Drug | QAX576 10 mg/kg |
| Placebo | Drug | Placebo |
Primary outcome
Measure: Assessing and comparing the safety and tolerability of multiple doses of QAX576 in controlled and partially controlled asthma patients.
Time frame: 120 Days
2 secondary outcomes
Assessing the pharmacokinetics of multiple doses of QAX576 in asthmatics
Time frame: 120 Days
Assessing the effect of QAX576 on asthma control using assessments such as exhaled NO, FEV1 variability data captures by PIKO-1 home monitoring device and the extent of inhaled salbutamol use as rescue medication.
Time frame: 120 Days
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 21 Dec 2020.
- Results for CQAX576A2107 can be found on the Novartis Clinical Trial Results 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
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing QAX576 in people with Asthma, run by Novartis Pharmaceuticals at 3 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 6 inclusion and 16 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 21 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 3 sites in Russia, United Kingdom. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Assessing and comparing the safety and tolerability of multiple doses of QAX576 in controlled and partially controlled asthma patients. (time frame: 120 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 21 Dec 2020.