Persistent AsthmaPhase 2NCT01253603
Efficacy, Safety, and Pharmacokinetics of QAW039
A Phase 2 study testing QAW039 capsules once daily for 28 days and Fluticasone propionate inhaler twice daily for 28 days in people with Persistent Asthma, run by Novartis Pharmaceuticals at 26 sites in 5 countries.
Trial summary
This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Persistent Asthma
- What is being tested?
- QAW039 capsules once daily for 28 days and Fluticasone propionate inhaler twice daily for 28 days
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 26 sitesin 5 countries
- Study dates
- Nov 2010to Sep 2011
- 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 a medical history of mild to moderate persistent allergic asthma.
- Patients must weigh at least 45 kg to participate in the study, and must have abody mass index (BMI) of >17 kg/m2.
- Female patients must be surgically sterilized, postmenopausal or using a double-barrier method of contraception
Who cannot join
- Women of child-bearing potential.
- Smokers defined as history of smoking in the previous 6 months or a smoking history of more than 10 pack years, a pack year being defined as smoking the equivalent of 20 cigarettes - a pack - every day for the period of 1 year
- Patients with severe persistent asthma
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
26 sites in 5 countries.
26 sites in 5 countries
United States18 sites
Novartis Investigative Site
Bellevue, Nebraska, 68123
Novartis Investigative Site
Berlin, New Jersey, 08009
Novartis Investigative Site
Dallas, Texas, 75231
Novartis Investigative Site
Encinitas, California, 92024
Novartis Investigative Site
Huntington Beach, California, 92647
Novartis Investigative Site
Los Angeles, California, 90025
Novartis Investigative Site
Los Angeles, California, 90048
Novartis Investigative Site
Medford, Oregon, 97504
Novartis Investigative Site
Mission Viejo, California, 92691
Novartis Investigative Site
North Dartmouth, Massachusetts, 02747
Novartis Investigative Site
Raleigh, North Carolina, 27607
Novartis Investigative Site
San Diego, California, 92120
Novartis Investigative Site
San Diego, California, 92123
Novartis Investigative Site
San Jose, California, 95117
Novartis Investigative Site
Skillman, New Jersey, 08558
Novartis Investigative Site
Stockbridge, Georgia, 30281
Novartis Investigative Site
Stockton, California, 95207
Novatis Investigative Site
Upland, Pennsylvania, 19013
Germany5 sites
Novartis Investigative Site
Berlin
Novartis Investigative Site
Cologne
Novartis Investigative Site
Frankfurt
Novartis Investigative Site
Hamburg
Novartis Investigative Site
Wiesbaden
About this study
Official title: A Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Pharmacokinetics of QAW039 in Steroid-free Patients With Mild to Moderate Persistent Asthma
This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent asthma.
- Conditions
- Persistent Asthma
- Being tested
- QAW039 capsules once daily for 28 days, Placebo to QAW039 capsules once daily for 28 days, Fluticasone propionate inhaler twice daily for 28 days
- 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.
QAW039 capsules once daily for 28 daysDrug
Placebo to QAW039 capsules once daily for 28 daysDrug
Fluticasone propionate inhaler twice daily for 28 daysDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | QAW039 capsules once daily for 28 days Receives: Drug: QAW039 capsules once daily for 28 days |
| 2 | Experimental | Placebo to QAW039 capsules once daily for 28 days Receives: Drug: Placebo to QAW039 capsules once daily for 28 days |
| 3 | Experimental | Fluticasone propionate inhaler twice daily for 28 days Receives: Drug: Fluticasone propionate inhaler twice daily for 28 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in trough forced expiratory volume in 1 second (FEV1) compared to placebo.
Measured: 28 days
Secondary outcomes (1)
To assess the safety of a 28 day administration of QAW039 compared to placebo, measured by vital signs, laboratory evaluations and electrocardiograms.
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 posted3 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent 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
- 170 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
- NCT01253603
- Sponsor's protocol ID
- CQAW039A2201
- Other IDs
- 2010-020177-16
- Status last verified
- Aug 2013
- First submitted
- 1 Dec 2010
- Last updated
- 19 Dec 2020
- Results posted
- No
Publications
Erpenbeck VJ, Popov TA, Miller D, Weinstein SF, Spector S, Magnusson B, Osuntokun W, Goldsmith P, Weiss M, Beier J. The oral CRTh2 antagonist QAW039 (fevipiprant): A phase II study in uncontrolled allergic asthma. Pulm Pharmacol Ther. 2016 Aug;39:54-63. doi: 10.1016/j.pupt.2016.06.005. Epub 2016 Jun 21.
PubMed 27354118
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, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Pharmacokinetics of QAW039 in Steroid-free Patients With Mild to Moderate Persistent Asthma
- ClinicalTrials.gov ID
- NCT01253603
- Acronym / sponsor ID
- CQAW039A2201
- Conditions
- Persistent Asthma
- Keywords
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 3 Dec 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, efficacy and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: QAW039 capsules once daily for 28 daysQAW039 capsules once daily for 28 days |
| 2 | Experimental | Drug: Placebo to QAW039 capsules once daily for 28 daysPlacebo to QAW039 capsules once daily for 28 days |
| 3 | Experimental | Drug: Fluticasone propionate inhaler twice daily for 28 daysFluticasone propionate inhaler twice daily for 28 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a medical history of mild to moderate persistent allergic asthma.
- Patients must weigh at least 45 kg to participate in the study, and must have abody mass index (BMI) of >17 kg/m2.
- Female patients must be surgically sterilized, postmenopausal or using a double-barrier method of contraception
Key exclusion criteria (4 listed)
- Women of child-bearing potential.
- Smokers defined as history of smoking in the previous 6 months or a smoking history of more than 10 pack years, a pack year being defined as smoking the equivalent of 20 cigarettes - a pack - every day for the period of 1 year
- Patients with severe persistent 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 |
|---|---|---|
| QAW039 capsules once daily for 28 days | Drug | 1 |
| Placebo to QAW039 capsules once daily for 28 days | Drug | 2 |
| Fluticasone propionate inhaler twice daily for 28 days | Drug | 3 |
Primary outcome
Change in trough forced expiratory volume in 1 second (FEV1) compared to placebo.
Time frame: 28 days
1 secondary outcome
To assess the safety of a 28 day administration of QAW039 compared to placebo, measured by vital signs, laboratory evaluations and electrocardiograms.
Time frame: 28 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 19 Dec 2020.
- Derived from this study: PubMed 27354118Erpenbeck VJ, Popov TA, Miller D, Weinstein SF, Spector S, Magnusson B, Osuntokun W, Goldsmith P, Weiss M, Beier J. The oral CRTh2 antagonist QAW039 (fevipiprant): A phase II study in uncontrolled allergic asthma. Pulm Pharmacol Ther. 2016 Aug;39:54-63. doi: 10.1016/j.pupt.2016.06.005. Epub 2016 Jun 21.
- Results for CQAW039A2201 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
26 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QAW039 capsules once daily for 28 days and Fluticasone propionate inhaler twice daily for 28 days in people with Persistent Asthma, run by Novartis Pharmaceuticals at 26 sites in 5 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 3 inclusion and 4 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 26 sites in United States, Germany, Belgium, Romania, South Korea. 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. 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?
Change in trough forced expiratory volume in 1 second (FEV1) compared to placebo. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01253603, which also lists 1 linked publication.
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.