AsthmaPhase 2NCT01716754
Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma
A Phase 2 study testing QGE031 and Omalizumab in people with Asthma, run by Novartis Pharmaceuticals at 150 sites in 24 countries.
Trial summary
This study assessed the effect on asthma control of different dose levels and regimens of QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- QGE031 and Omalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 471 participants
- Where
- 150 sitesin 24 countries
- Study dates
- Dec 2012to Jan 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of allergic asthma , uncontrolled on current medication.
- History of at least 1 asthma exacerbation during the last 1 year
- Forced Expiratory Volume in one second (FEV1) of ≥ 40% and ≤ 80% of the predicted normal value; reversibility following administration of bronchodilator must also be demonstrated (historical positive reversibility or bronchoprovocation result can be used).
Who cannot join
- Baseline IgE levels or body weight outside the omalizumab dosing table.
- Use of tobacco products within the previous 6 months (Social occasional smokers may be included).
- Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.
Trial locations and contacts
150 sites in 24 countries.
150 sites in 24 countries
United States22 sites
Novartis Investigative Site
Brooklyn, New York, 11229
Novartis Investigative Site
Cincinnati, Ohio, 45231
Novartis Investigative Site
Columbia, Maryland, 21044
Novartis Investigative Site
Evansville, Indiana, 47713
Novartis Investigative Site
Everett, Washington, 98208
Novartis Investigative Site
Fairfax, Virginia, 22030
Novartis Investigative Site
Fresno, California, 93720
Novartis Investigative Site
Hawaiian Gardens, California, 90716
Novartis Investigative Site
Lincoln, Rhode Island, 02865
Novartis Investigative Site
Mineola, New York, 11501
Novartis Investigative Site
Minneapolis, Minnesota, 55402
Novartis Investigative Site
Mt. Pleasant, South Carolina, 29464
Novartis Investigative Site
Novi, Michigan, 48375
Novartis Investigative Site
Omaha, Nebraska, 68130
Novartis Investigative Site
Owensboro, Kentucky, 42301
Novartis Investigative Site
Papillion, Nebraska, 68046
Novartis Investigative Site
Riverside, California, 92506
Novartis Investigative Site
Salt Lake City, Utah, 84108
Novartis Investigative Site
San Jose, California, 95117
Novartis Investigative Site
Summerville, South Carolina, 29485
Novartis Investigative Site
Vista, California, 92083
Novartis Investigative Site
Waldorf, Maryland, 20602
Russia15 sites
Novartis Investigative Site
Barnaul, 656045
Novartis Investigative Site
Chelyabinsk, 454000
Novartis Investigative Site
Chelyabinsk, 454021
Novartis Investigative Site
Moscow, 119992
Novartis Investigative Site
Moscow, 125315
Novartis Investigative Site
Moscow, 127018
Novartis Investigative Site
N.Novgorod, 603126
Novartis Investigative Site
Nizhny Novgorod, 603018
Novartis Investigative Site
Penza, 440026
Novartis Investigative Site
Ryazan, 390026
Novartis Investigative Site
Saint Petersburg, 193312
Novartis Investigative Site
Saint Petersburg, 194354
Novartis Investigative Site
Saint Petersburg, 197022
Novartis Investigative Site
Saratov, 410012
Novartis Investigative Site
Yaroslavl, 150003
Argentina13 sites
Novartis Investigative Site
Buenos Aires, B1842DID
Novartis Investigative Site
Buenos Aires, C1125ABE
Novartis Investigative Site
CABA, Buenos Aires, C1122AAK
Novartis Investigative Site
CABA, Buenos Aires, C1426ABP
Novartis Investigative Site
CABA, Buenos Aires F.D., C1430CKE
Novartis Investigative Site
Mar del Plata, Buenos Aires, 7600
Novartis Investigative Site
Mendoza, M5500CBA
Novartis Investigative Site
Mendoza, M5500FIK
Novartis Investigative Site
Rosario, Santa Fe Province, S2000AII
Novartis Investigative Site
Rosario, Santa Fe Province, S2000CXH
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, 4000
Novartis Investigative Site
Santa Fe, Rosario, S2000DBS
Novartis Investigative Site
Santa Fe, S3000FIL
Romania13 sites
Novartis Investigative Site
Brasov, 500086
Novartis Investigative Site
Brasov, 500112
Novartis Investigative Site
Brasov, 500281
Novartis Investigative Site
Bucharest, District 1, 10457
Novartis Investigative Site
Bucharest, District 3, 030303
Novartis Investigative Site
Bucharest, District 3, 030317
Novartis Investigative Site
Bucharest, ROM, 12071
Novartis Investigative Site
Bucharest, 011461
Novartis Investigative Site
Bucharest, 050159
Novartis Investigative Site
Cluj-Napoca, 400139
Novartis Investigative Site
Cluj-Napoca, 400371
Novartis Investigative Site
Constanța, Jud. Constanta, 900002
Novartis Investigative Site
Piteşti, 110114
Germany8 sites
Novartis Investigative Site
Frankfurt, 60596
Novartis Investigative Site
Hamburg, 20354
Novartis Investigative Site
Homburg, 66421
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
Leipzig, 04275
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Roth, 91154
Novartis Investigative Site
Rüdersdorf, 15562
Slovakia8 sites
Novartis Investigative Site
Bardejov, 085 01
Novartis Investigative Site
Bratislava, Slovak Republic, 831 03
Novartis Investigative Site
Bratislava, 826 06
Novartis Investigative Site
Košice, 04001
Novartis Investigative Site
Nitra, Slovak Republic, 949 01
Novartis Investigative Site
Prievidza, 97101
Novartis Investigative Site
Ružomberok, 034 26
Novartis Investigative Site
Trenčín, 91101
South Korea7 sites
Novartis Investigative Site
Bucheon-si, Gyeonggi-do, 14584
Novartis Investigative Site
Cheongju-si, North Chungcheong, 28644
Novartis Investigative Site
Gwangju, 501-757
Novartis Investigative Site
Seoul, Korea, 08308
Novartis Investigative Site
Seoul, 120-752
Novartis Investigative Site
Seoul, 156-755
Novartis Investigative Site
Suwon, Gyeonggi-do, 16499
Czechia6 sites
Novartis Investigative Site
Břeclav, 690 02
Novartis Investigative Site
Brno, Czech Republic, 639 00
Novartis Investigative Site
Brno, 615 00
Novartis Investigative Site
Tábor, 390 01
Novartis Investigative Site
Teplice, CZE, 415 01
Novartis Investigative Site
Trutnov, Czech Republic, 541 01
Israel6 sites
Novartis Investigative Site
Haifa, 3436212
Novartis Investigative Site
Jerusalem, 91031
Novartis Investigative Site
Jerusalem, 9112001
Novartis Investigative Site
Kfar Saba, 4428164
Novartis Investigative Site
Petah Tikva, 49100
Novartis Investigative Site
Rehovot, 7610001
Italy6 sites
Novartis Investigative Site
Messina, ME, 98125
Novartis Investigative Site
Milan, MI, 20123
Novartis Investigative Site
Padova, PD, 35128
Novartis Investigative Site
Pisa, PI, 56124
Novartis Investigative Site
Reggio Emilia, RE, 42123
Novartis Investigative Site
Verona, VR, 37126
Turkey (Türkiye)6 sites
Novartis Investigative Site
Aydin, 09100
Novartis Investigative Site
Fatih / Istanbul, 34098
Novartis Investigative Site
Istanbul, 34093
Novartis Investigative Site
Istanbul, 34854
Novartis Investigative Site
Izmir, 35040
Novartis Investigative Site
Mersin, 33079
Portugal5 sites
Novartis Investigative Site
Coimbra, 3041-853
Novartis Investigative Site
Lisbon, 1169-024
Novartis Investigative Site
Lisbon, 1749-035
Novartis Investigative Site
Porto, 4100-180
Novartis Investigative Site
Vila Nova de Gaia, 4434-502
Canada4 sites
Novartis Investigative Site
Montreal, Quebec, H3G 1L5
Novartis Investigative Site
Ottawa, Ontario, K1Y 4G2
Novartis Investigative Site
Québec, G1V 4W2
Novartis Investigative Site
Saint-Charles-Borromée, Quebec, J6E 2B4
France4 sites
Novartis Investigative Site
Le Kremlin-Bicêtre, 94275
Novartis Investigative Site
Marseille, 13915
Novartis Investigative Site
Montpellier, 34059
Novartis Investigative Site
Strasbourg, 67091
Hungary4 sites
Novartis Investigative Site
Budapest, 1121
Novartis Investigative Site
Debrecen, 4032
Novartis Investigative Site
Pécs, 7635
Novartis Investigative Site
Törökbálint, 2045
United Kingdom4 sites
Novartis Investigative Site
Birmingham, B9 5SS
Novartis Investigative Site
Bradford, West Yorkshire, BD9 6RJ
Novartis Investigative Site
East Yorkshire, HU16 5JQ
Novartis Investigative Site
Southampton, SO16 6YD
Finland3 sites
Novartis Investigative Site
Helsinki, 00290
Novartis Investigative Site
Tampere, 33520
Novartis Investigative Site
Turku, 20521
Guatemala3 sites
Novartis Investigative Site
Guatemala City, GTM, 01010
Novartis Investigative Site
Guatemala City, GTM, 01011
Novartis Investigative Site
Guatemala City, 01011
India3 sites
Novartis Investigative Site
Dhantoli, Nagpur, 12
Novartis Investigative Site
Karamsad, Gujarat, 388325
Novartis Investigative Site
Panjim, Goa, 403 002
South Africa3 sites
Novartis Investigative Site
Cape Town, 7505
Novartis Investigative Site
Cape Town, 7531
Novartis Investigative Site
Durban, 4001
Mexico2 sites
Novartis Investigative Site
Guadalajara, Jalisco, 44130
Novartis Investigative Site
México, D.F., Mexico City, 06700
Poland2 sites
Novartis Investigative Site
Bialystok, 15-276
Novartis Investigative Site
Lodz, 90-153
Singapore2 sites
Novartis Investigative Site
Singapore, 169608
Novartis Investigative Site
Singapore, 308433
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo and Active-controlled Study With Exploratory Dose-ranging to Investigate the Efficacy and Safety of 16 Weeks Treatment With Subcutaneous (s.c.) QGE031 in Asthma Patients Not Adequately Controlled With High-dose Inhaled Corticosteroids and Long Acting β2-agonists
This study assessed the effect on asthma control of different dose levels and regimens of QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab. Information from this study was planned to support the design of future studies.
- Conditions
- Asthma
- Being tested
- QGE031, Omalizumab, Placebo
- Keywords
- asthma, asthma control, allergy, atopic, IgE, double-blind, placebo, omalizumab
- Medical subject headings
- Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QGE031Drug
QGE031 was supplied as 120 mg liquid in vial per 1 mL
OmalizumabDrug
Also called Xolair
Omalizumab was supplied as 150 mg lyophilisate in vial
PlaceboDrug
Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL
| Study group | Role | What they receive |
|---|---|---|
| QGE031 240 mg every 2 weeks (q2w) | Experimental | Participants received QGE031 240 mg subcutaneously (s.c.) q2w for 16 weeks. Receives: Drug: QGE031 |
| QGE031 240 mg q4w | Experimental | Participants received QGE031 240 mg s.c. q4w for 16 weeks. Receives: Drug: QGE031 |
| QGE031 180 mg q2w | Experimental | Participants received QGE031 180 mg s.c. q2w for 16 weeks. Receives: Drug: QGE031 |
| QGE031 120 mg q2w | Experimental | Participants received QGE031 120 mg s.c. q2w for 16 weeks. Receives: Drug: QGE031 |
| QGE031 36 mg q2w | Experimental | Participants received QGE031 36 mg s.c. q2w for 16 weeks. Receives: Drug: QGE031 |
| QGE031 12 mg q2w | Experimental | Participants received QGE031 12 mg s.c. q2w for 16 weeks. Receives: Drug: QGE031 |
| Omalizumab (as per locally approved dosing table) | Active comparator | Participants received omalizumab as per locally approved dosing table s.c. q2w or q4w for 16 weeks. Receives: Drug: Omalizumab |
| Placebo to QGE031 240 mg q2w | Placebo comparator | Participants received matching placebo to QGE031 240 mg s.c. q2w for 16 weeks. Receives: Drug: Placebo |
| Placebo to QGE031 240 mg q4w | Placebo comparator | Participants received placebo to QGE031 240 mg s.c. q2w for 16 weeks. Receives: Drug: Placebo |
| Placebo to QGE031 180 mg q2w | Placebo comparator | Participants received QGE031 180 mg s.c. q2w for 16 weeks. Receives: Drug: Placebo |
| Placebo to QGE031 120 mg q2w | Placebo comparator | Participants received QGE031 120 mg s.c. q2w for 16 weeks. Receives: Drug: Placebo |
| Placebo to QGE031 36 mg q2w | Placebo comparator | Participants received QGE031 36 mg s.c. q2w for 16 weeks. Receives: Drug: Placebo |
| Placebo to QGE031 12 mg q2w | Placebo comparator | Participants received QGE031 12 mg s.c. q2w for 16 weeks. Receives: Drug: Placebo |
| Placebo to omalizumab | Placebo comparator | Participants received placebo to omalizumab s.c. q2w or q4w for 16 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of QGE031 Participants With Clinically Important Improvement of <= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo
The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.
Measured: Week 16
Secondary outcomes (4)
Change From Baseline in ACQ-7 Score
The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7. A negative change from baseline indicates improvement.
Measured: Baseline, Weeks 4, 8, 12, 16 and 28
Percentage of Participants With a Change From Baseline in ACQ-7 Score Less Than -1.1
The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.
Measured: Week 16
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score
The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to participants with asthma. The 32 items in the AQLQ were divided into four domain-specific scores and a total score as follows: Activity limitations = Mean of Items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32 (11 items); Symptoms = Mean of Items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30 (12 items); Emotional function = Mean of Items 7, 13, 15, 21, 27 (5 items); Environmental stimuli = Mean of Items 9, 17, 23, 26 (4 items); and Overall Score = Mean of Items 1 to 32 (32 items). Each item of the AQLQ was equally weighted and scored along a 7-point scale, where 1 indicates maximal impairment and 7 indicates no impairment. Thus, higher scores indicate better asthma-related quality of life. The mean overall score ranged from 1 to 7. A positive change from baseline indicates improvement.
Measured: Baseline, Week 16, Week 28
Change From Baseline in Mean Number of Puffs of Morning, Evening and Total Daily Asthma Rescue Medication
Participants recorded their use of rescue medication into an electronic diary (eDiary). A negative change from baseline indicates improvement.
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionJan 2016
- Study completionJan 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 471 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
- NCT01716754
- Sponsor's protocol ID
- CQGE031B2201
- Other IDs
- 2012-002298-69
- Status last verified
- Aug 2017
- First submitted
- 19 Oct 2012
- Last updated
- 11 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo and Active-controlled Study With Exploratory Dose-ranging to Investigate the Efficacy and Safety of 16 Weeks Treatment With Subcutaneous (s.c.) QGE031 in Asthma Patients Not Adequately Controlled With High-dose Inhaled Corticosteroids and Long Acting β2-agonists
- ClinicalTrials.gov ID
- NCT01716754
- Acronym / sponsor ID
- CQGE031B2201
- Conditions
- Asthma
- Keywords
- asthma, asthma control, allergy, atopic, IgE, double-blind, placebo, omalizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Posted 8 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assessed the effect on asthma control of different dose levels and regimens of QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab. Information from this study was planned to support the design of future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| QGE031 240 mg every 2 weeks (q2w) | Experimental | Drug: QGE031Participants received QGE031 240 mg subcutaneously (s.c.) q2w for 16 weeks. |
| QGE031 240 mg q4w | Experimental | Drug: QGE031Participants received QGE031 240 mg s.c. q4w for 16 weeks. |
| QGE031 180 mg q2w | Experimental | Drug: QGE031Participants received QGE031 180 mg s.c. q2w for 16 weeks. |
| QGE031 120 mg q2w | Experimental | Drug: QGE031Participants received QGE031 120 mg s.c. q2w for 16 weeks. |
| QGE031 36 mg q2w | Experimental | Drug: QGE031Participants received QGE031 36 mg s.c. q2w for 16 weeks. |
| QGE031 12 mg q2w | Experimental | Drug: QGE031Participants received QGE031 12 mg s.c. q2w for 16 weeks. |
| Omalizumab (as per locally approved dosing table) | Active comparator | Drug: OmalizumabParticipants received omalizumab as per locally approved dosing table s.c. q2w or q4w for 16 weeks. |
| Placebo to QGE031 240 mg q2w | Placebo comparator | Drug: PlaceboParticipants received matching placebo to QGE031 240 mg s.c. q2w for 16 weeks. |
| Placebo to QGE031 240 mg q4w | Placebo comparator | Drug: PlaceboParticipants received placebo to QGE031 240 mg s.c. q2w for 16 weeks. |
| Placebo to QGE031 180 mg q2w | Placebo comparator | Drug: PlaceboParticipants received QGE031 180 mg s.c. q2w for 16 weeks. |
| Placebo to QGE031 120 mg q2w | Placebo comparator | Drug: PlaceboParticipants received QGE031 120 mg s.c. q2w for 16 weeks. |
| Placebo to QGE031 36 mg q2w | Placebo comparator | Drug: PlaceboParticipants received QGE031 36 mg s.c. q2w for 16 weeks. |
| Placebo to QGE031 12 mg q2w | Placebo comparator | Drug: PlaceboParticipants received QGE031 12 mg s.c. q2w for 16 weeks. |
| Placebo to omalizumab | Placebo comparator | Drug: PlaceboParticipants received placebo to omalizumab s.c. q2w or q4w for 16 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A diagnosis of allergic asthma , uncontrolled on current medication.
- History of at least 1 asthma exacerbation during the last 1 year
- Forced Expiratory Volume in one second (FEV1) of ≥ 40% and ≤ 80% of the predicted normal value; reversibility following administration of bronchodilator must also be demonstrated (historical positive reversibility or bronchoprovocation result can be used).
Key exclusion criteria (3 listed)
- Baseline IgE levels or body weight outside the omalizumab dosing table.
- Use of tobacco products within the previous 6 months (Social occasional smokers may be included).
- Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.
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 |
|---|---|---|
| QGE031QGE031 was supplied as 120 mg liquid in vial per 1 mL | Drug | QGE031 12 mg q2w, QGE031 120 mg q2w, QGE031 180 mg q2w, QGE031 240 mg every 2 weeks (q2w), QGE031 240 mg q4w, QGE031 36 mg q2w |
| OmalizumabAlso: XolairOmalizumab was supplied as 150 mg lyophilisate in vial | Drug | Omalizumab (as per locally approved dosing table) |
| PlaceboPlacebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL | Drug | Placebo to QGE031 12 mg q2w, Placebo to QGE031 120 mg q2w, Placebo to QGE031 180 mg q2w, Placebo to QGE031 240 mg q2w, Placebo to QGE031 240 mg q4w, Placebo to QGE031 36 mg q2w, Placebo to omalizumab |
Primary outcome
Percentage of QGE031 Participants With Clinically Important Improvement of <= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo
Time frame: Week 16
The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.
4 secondary outcomes
Change From Baseline in ACQ-7 Score
Time frame: Baseline, Weeks 4, 8, 12, 16 and 28
Percentage of Participants With a Change From Baseline in ACQ-7 Score Less Than -1.1
Time frame: Week 16
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score
Time frame: Baseline, Week 16, Week 28
Change From Baseline in Mean Number of Puffs of Morning, Evening and Total Daily Asthma Rescue Medication
Time frame: Baseline, Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
150 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QGE031 and Omalizumab in people with Asthma, run by Novartis Pharmaceuticals at 150 sites in 24 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 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: finished, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 150 sites in United States, Russia, Argentina, Romania, Germany and 19 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 8 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?
Percentage of QGE031 Participants With Clinically Important Improvement of <= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo (time frame: Week 16). 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 11 Aug 2017.