AsthmaPhase 2NCT01836471
A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients
A Phase 2 study testing QAW039, Fluticasone 250 mcg and Fluticasone 100 mcg in people with Asthma, run by Novartis Pharmaceuticals at 76 sites in 10 countries.
Trial summary
The purpose of the study was to assess the clinical effect of QAW039 in non-atopic asthmatics taking low dose Inhaled Corticosteroid (ICS) as background therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- QAW039, Fluticasone 250 mcg and Fluticasone 100 mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 345 participants
- Where
- 76 sitesin 10 countries
- Study dates
- May 2013to Feb 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained before any assessment is performed
- Patients with a diagnosis of persistent asthma (according to Global Initiative for Asthma 2011) for a period of at least 6 months prior to screening
- Patients with a pre-bronchodilator Forced Expiratory Volume In One Second (FEV1) value of 40% to 80% of individual predicted value at screening and prior to treatment
- An Asthma Control Questionnaire score ≥ 1.5 prior to treatment
- Demonstration of reversible airway obstruction
Who cannot join
- Pregnant or nursing (lactating) women
- Acute illness other than asthma at the start of the study
- Patients with clinically significant laboratory abnormalities at screening
- Patients with clinically significant condition which may compromise subject safety or interfere with study evaluation
- Use of other investigational drugs at the time of enrollment
Trial locations and contacts
76 sites in 10 countries.
76 sites in 10 countries
United States30 sites
Novartis Investigative Site
Charleston, South Carolina, 29407
Novartis Investigative Site
Charlotte, North Carolina, 28207
Novartis Investigative Site
Cincinnati, Ohio, 45231
Novartis Investigative Site
Colorado Springs, Colorado, 80907
Novartis Investigative Site
Denver, Colorado, 80206
Novartis Investigative Site
Denver, Colorado, 80230
Novartis Investigative Site
Encinitas, California, 92024
Novartis Investigative Site
Huntington Beach, California, 92647
Novartis Investigative Site
Lincoln, Rhode Island, 02865
Novartis Investigative Site
Los Angeles, California, 90025
Novartis Investigative Site
Los Angeles, California, 90048
Novartis Investigative Site
Medford, Oregon, 97504-8741
Novartis Investigative Site
Minneapolis, Minnesota, 55402
Novartis Investigative Site
Mission Viejo, California, 92691
Novartis Investigative Site
North Dartmouth, Massachusetts, 02747
Novartis Investigative Site
Orange, California, 92868
Novartis Investigative Site
Owensboro, Kentucky, 42301
Novartis Investigative Site
Palmdale, California, 93551
Novartis Investigative Site
Papillion, Nebraska, 68046
Novartis Investigative Site
Portland, Oregon, 97213
Novartis Investigative Site
Riverside, California, 92506
Novartis Investigative Site
Rolling Hills Estates, California, 90274
Novartis Investigative Site
San Diego, California, 92123
Novartis Investigative Site
San Jose, California, 95117
Novartis Investigative Site
Sarasota, Florida, 34233
Novartis Investigative Site
Seattle, Washington, 98104
Novartis Investigative Site
Skillman, New Jersey, 08558
Novartis Investigative Site
St Louis, Missouri, 63128
Novartis Investigative Site
St Louis, Missouri, 63141
Novartis Investigative Site
Stockton, California, 95207
Romania8 sites
Novartis Investigative Site
Arad, 310013
Novartis Investigative Site
Bucharest, District 1, 10457
Novartis Investigative Site
Bucharest, District 3, 030303
Novartis Investigative Site
Bucharest, District 3, 030317
Novartis Investigative Site
Craiova, Dolj, 200515
Novartis Investigative Site
Craiova, 200515
Novartis Investigative Site
Deva, 330162
Novartis Investigative Site
Timișoara, Romania, 300736
Germany7 sites
Novartis Investigative Site
Berlin, 10717
Novartis Investigative Site
Frankfurt, 60596
Novartis Investigative Site
Leipzig, 04357
Novartis Investigative Site
Lübeck, 23552
Novartis Investigative Site
Marburg, Germany, D-35037
Novartis Investigative Site
Wiesbaden, Germany, 65187
Novartis Investigative Site
Witten, 58452
South Africa7 sites
Novartis Investigative Site
Cape Town, 7500
Novartis Investigative Site
Cape Town, 7531
Novartis Investigative Site
Cape Town, 7925
Novartis Investigative Site
Cape Town, 8001
Novartis Investigative Site
Durban, South Africa, 4001
Novartis Investigative Site
Gatesville, 7764
Novartis Investigative Site
Pretoria, 0181
India5 sites
Novartis Investigative Site
Coimbatore, Tamil Nadu, 641 045
Novartis Investigative Site
Hyderabad, Andhra Pradesh, 500 068
Novartis Investigative Site
Nagpur, Maharashtra, 400 012
Novartis Investigative Site
Nagpur, Maharashtra, 440010
Novartis Investigative Site
Panjim, Goa, 403 002
South Korea5 sites
Novartis Investigative Site
Bucheon-si, Gyeonggi-do, 14584
Novartis Investigative Site
Cheongju-si, North Chungcheong, 28644
Novartis Investigative Site
Gwangju, Gwangju, 501-757
Novartis Investigative Site
Seoul, Korea, 06591
Novartis Investigative Site
Suwon, Gyeonggi-do, 443-721
Colombia4 sites
Novartis Investigative Site
Barranquilla, Atlántico
Novartis Investigative Site
Barranquilla
Novartis Investigative Site
Bogotá, Cundinamarca
Novartis Investigative Site
Medellín
Czechia4 sites
Novartis Investigative Site
Hradec Králové, CZE, 500 05
Novartis Investigative Site
Karlovy Vary-Stara Rokle, CZE, 360 17
Novartis Investigative Site
Teplice, CZE, 415 01
Novartis Investigative Site
Trutnov, Czech Republic, 541 01
Poland4 sites
Novartis Investigative Site
Bialystok, 15-010
Novartis Investigative Site
Bialystok, 15-044
Novartis Investigative Site
Lodz, 90-153
Novartis Investigative Site
Wroclaw, 50-349
Belgium2 sites
Novartis Investigative Site
Erpent, 5100
Novartis Investigative Site
Liège, 4000
About this study
Official title: A Double-blind, Placebo-controlled, Study Examining the Effect of Orally Administered QAW039 (450 mg QD) on FEV1 and ACQ in Non-atopic, Asthmatic Patients With a Baseline, Pre-bronchodilator FEV1 of 40-80% Predicted, Inadequately Controlled With Low Dose ICS Therapy
The purpose of the study was to assess the clinical effect of QAW039 in non-atopic asthmatics taking low dose Inhaled Corticosteroid (ICS) as background therapy.
Read the detailed description
This was a multi-centre, randomised, placebo-controlled, double blind, 3-arm study designed to compare the efficacy and safety of a once daily dose of QAW039 with placebo in non-atopic and atopic asthmatics both inadequately controlled despite receiving a low dose ICS background therapy, over a 12 week treatment period. Efficacy and safety of a once daily dose of QAW039 was also compared with an increased dose of ICS in atopic asthmatics taking low dose ICS as background therapy.
- Conditions
- Asthma
- Being tested
- QAW039, Placebo QAW039, Fluticasone 250 mcg, Fluticasone 100 mcg
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QAW039Drug
QAW039 supplied as hard gelatin capsule in unit dose strength of 150 mg. Patient took 450 mg once daily (3 capsules taken with food in the morning) for the approximate period of the study (12 weeks)
Placebo QAW039Drug
Matching placebo for QAW039 supplied as hard gelatin capsule were identical in appearance to their active counterparts. Patients took 3 QAW039 matching placebo capsules once a day ( taken with food in the morning) for the approximate period of the study (12 weeks)
Fluticasone 250 mcgDrug
Fluticasone was supplied in inhalers with dose strength of 250 mcg. Patients took 250 mcg bid (morning and evening approximately 12 hours between doses) for a total dose of 500 mcg daily for the approximate period of the study (12 weeks).
Fluticasone 100 mcgDrug
Background therapy - fluticasone was supplied in inhalers with dose strength of 100 mcg. All patients in the study other than the Atopic Fluticasone 150 mcg arm were given the 100 mcg dose strength inhalers and took fluticasone 100 mcg bid (taken morning and evening with approximately 12 hours between doses) as background therapy for the approximate period of the study (12 weeks).
| Study group | Role | What they receive |
|---|---|---|
| QAW039 450 mg qd Non-atopic | Experimental | QAW039 450 mg (3 capsules of QAW039 150 mg) qd combined with background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1. Receives: Drug: QAW039; Drug: Fluticasone 100 mcg |
| Placebo Non-atopic | Placebo comparator | Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with background ICS (100 μg fluticasone, bid). Non-atopic randomized in ratio of approximately 1:1. Receives: Drug: Placebo QAW039; Drug: Fluticasone 100 mcg |
| QAW039 450 mg qd Atopic | Experimental | QAW039 450 mg (3 capsules of QAW039 150 mg) qd combined with background ICS (100 μg fluticasone, bid). Atopic patients randomized in a ratio of approximate 1:1:1 Receives: Drug: QAW039; Drug: Fluticasone 100 mcg |
| Fluticasone 150 mcg bid Atopic | Active comparator | Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with 150 μg ICS and with background ICS (100 μg fluticasone, bid). As a consequence total ICS was 250 μg fluticasone bid. Atopic patients randomized in ratio of approximately 1:1:1 Receives: Drug: Placebo QAW039; Drug: Fluticasone 250 mcg |
| Placebo Atopic | Placebo comparator | Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with background ICS (100 μg fluticasone, bid). Atopic patients andomized in ratio of approximately 1:1:1 Receives: Drug: Placebo QAW039; Drug: Fluticasone 100 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Trough FEV1 (L) in Non-atopic Patients at Week 12 - Full Analysis Set
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.
Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF).
Estimates are from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug.
Measured: baseline,12 weeks
Secondary outcomes (4)
Change From Baseline in Trough FEV1 (L) in Atopic Patients at Week 12 - Full Analysis Set
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the FEV1 measurement taken prior to the first dose of randomized study drug.
Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF).
Estimates are from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug.
Measured: baseline,12 weeks
Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the FEV1 measurement taken prior to the first dose of randomized study drug.
Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF).
Estimates are from a mixed effects model with treatment, subject population, treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug.
Measured: baseline,12 weeks
Change From Baseline in ACQ-6 Score at Week 12 Non-atopic and Atopic Patients at Week 12 - Full Analysis Set
ACQ-6 consists of:5 items on symptoms, 1 item on rescue bronchodilator use, and 1 item on airway caliber (FEV1 % predicted). The ACQ was fully validated, including a minimal important difference (MID) or smallest change that could be considered clinically important (0.5). The ACQ was self-administered at the clinic and patients scored each item on a 7-point response scale: 0 = 'totally controlled' and 6 = 'severely uncontrolled.' Study staff scored question 7 based on % predicted FEV1 (ideally pre-bronchodilator). The total score=average of first 6 questions. Baseline=the ACQ-6 measurement taken prior to first dose of randomized study drug. The single missing score was interpolated by utilizing prior or subsequent completions of the questionnaire. Estimates were from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline ACQ-6 and region as fixed effects and center nested within region as random effects.
Measured: baseline,12 weeks
Change From Baseline in ACQ-6 Score at Week 12 Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set
ACQ-6 consists of:5 items on symptoms, 1 item on rescue bronchodilator use, and 1 item on airway caliber (FEV1 % predicted). The ACQ was fully validated, including a minimal important difference (MID) or smallest change that could be considered clinically important (0.5). The ACQ was self-administered at the clinic and patients scored each item on a 7-point response scale: 0 = 'totally controlled' and 6 = 'severely uncontrolled.' Study staff scored question 7 based on % predicted FEV1 (ideally pre-bronchodilator). The total score=average of first 6 questions. Baseline=the ACQ-6 measurement taken prior to first dose of randomized study drug. The single missing score was interpolated by utilizing prior or subsequent completions of the questionnaire. Estimates were from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline ACQ-6 and region as fixed effects and center nested within region as random effects.
Measured: baseline,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Kay, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836471
- Sponsor's protocol ID
- CQAW039A2214
- Other IDs
- 2012-003995-38
- Status last verified
- Jan 2017
- First submitted
- 17 Apr 2013
- Last updated
- 20 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Study Examining the Effect of Orally Administered QAW039 (450 mg QD) on FEV1 and ACQ in Non-atopic, Asthmatic Patients With a Baseline, Pre-bronchodilator FEV1 of 40-80% Predicted, Inadequately Controlled With Low Dose ICS Therapy
- ClinicalTrials.gov ID
- NCT01836471
- Acronym / sponsor ID
- CQAW039A2214
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 22 Apr 2013 (estimated)
- Results
- Posted 20 Mar 2017
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 the study was to assess the clinical effect of QAW039 in non-atopic asthmatics taking low dose Inhaled Corticosteroid (ICS) as background therapy.
Detailed description
This was a multi-centre, randomised, placebo-controlled, double blind, 3-arm study designed to compare the efficacy and safety of a once daily dose of QAW039 with placebo in non-atopic and atopic asthmatics both inadequately controlled despite receiving a low dose ICS background therapy, over a 12 week treatment period. Efficacy and safety of a once daily dose of QAW039 was also compared with an increased dose of ICS in atopic asthmatics taking low dose ICS as background therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| QAW039 450 mg qd Non-atopic | Experimental | Drug: QAW039, Drug: Fluticasone 100 mcgQAW039 450 mg (3 capsules of QAW039 150 mg) qd combined with background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1. |
| Placebo Non-atopic | Placebo comparator | Drug: Placebo QAW039, Drug: Fluticasone 100 mcgPlacebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with background ICS (100 μg fluticasone, bid). Non-atopic randomized in ratio of approximately 1:1. |
| QAW039 450 mg qd Atopic | Experimental | Drug: QAW039, Drug: Fluticasone 100 mcgQAW039 450 mg (3 capsules of QAW039 150 mg) qd combined with background ICS (100 μg fluticasone, bid). Atopic patients randomized in a ratio of approximate 1:1:1 |
| Fluticasone 150 mcg bid Atopic | Active comparator | Drug: Placebo QAW039, Drug: Fluticasone 250 mcgPlacebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with 150 μg ICS and with background ICS (100 μg fluticasone, bid). As a consequence total ICS was 250 μg fluticasone bid. Atopic patients randomized in ratio of approximately 1:1:1 |
| Placebo Atopic | Placebo comparator | Drug: Placebo QAW039, Drug: Fluticasone 100 mcgPlacebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with background ICS (100 μg fluticasone, bid). Atopic patients andomized in ratio of approximately 1:1:1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent must be obtained before any assessment is performed
- Patients with a diagnosis of persistent asthma (according to Global Initiative for Asthma 2011) for a period of at least 6 months prior to screening
- Patients with a pre-bronchodilator Forced Expiratory Volume In One Second (FEV1) value of 40% to 80% of individual predicted value at screening and prior to treatment
- An Asthma Control Questionnaire score ≥ 1.5 prior to treatment
- Demonstration of reversible airway obstruction
Key exclusion criteria (5 listed)
- Pregnant or nursing (lactating) women
- Acute illness other than asthma at the start of the study
- Patients with clinically significant laboratory abnormalities at screening
- Patients with clinically significant condition which may compromise subject safety or interfere with study evaluation
- Use of other investigational drugs at the time of enrollment
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 |
|---|---|---|
| QAW039QAW039 supplied as hard gelatin capsule in unit dose strength of 150 mg. Patient took 450 mg once daily (3 capsules taken with food in the morning) for the approximate period of the study (12 weeks) | Drug | QAW039 450 mg qd Atopic, QAW039 450 mg qd Non-atopic |
| Placebo QAW039Matching placebo for QAW039 supplied as hard gelatin capsule were identical in appearance to their active counterparts. Patients took 3 QAW039 matching placebo capsules once a day ( taken with food in the morning) for the approximate period of the study (12 weeks) | Drug | Fluticasone 150 mcg bid Atopic, Placebo Atopic, Placebo Non-atopic |
| Fluticasone 250 mcgFluticasone was supplied in inhalers with dose strength of 250 mcg. Patients took 250 mcg bid (morning and evening approximately 12 hours between doses) for a total dose of 500 mcg daily for the approximate period of the study (12 weeks). | Drug | Fluticasone 150 mcg bid Atopic |
| Fluticasone 100 mcgBackground therapy - fluticasone was supplied in inhalers with dose strength of 100 mcg. All patients in the study other than the Atopic Fluticasone 150 mcg arm were given the 100 mcg dose strength inhalers and took fluticasone 100 mcg bid (taken morning and evening with approximately 12 hours between doses) as background therapy for the approximate period of the study (12 weeks). | Drug | Placebo Atopic, Placebo Non-atopic, QAW039 450 mg qd Atopic, QAW039 450 mg qd Non-atopic |
Primary outcome
Change From Baseline in Trough FEV1 (L) in Non-atopic Patients at Week 12 - Full Analysis Set
Time frame: baseline,12 weeks
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug. Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF). Estimates are from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug.
4 secondary outcomes
Change From Baseline in Trough FEV1 (L) in Atopic Patients at Week 12 - Full Analysis Set
Time frame: baseline,12 weeks
Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set
Time frame: baseline,12 weeks
Change From Baseline in ACQ-6 Score at Week 12 Non-atopic and Atopic Patients at Week 12 - Full Analysis Set
Time frame: baseline,12 weeks
Change From Baseline in ACQ-6 Score at Week 12 Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set
Time frame: baseline,12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Richard Kay study director
Novartis Pharmaceuticals
76 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QAW039, Fluticasone 250 mcg and Fluticasone 100 mcg in people with Asthma, run by Novartis Pharmaceuticals at 76 sites in 10 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 20 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 76 sites in United States, Romania, Germany, South Africa, India and 5 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?
Yes. Results are posted in the registry (first posted 20 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline in Trough FEV1 (L) in Non-atopic Patients at Week 12 - Full Analysis Set (time frame: baseline,12 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 20 Mar 2017.