Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT01610037
Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation
A Phase 3 study testing QVA149 and Tiotropium in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 116 sites in 17 countries.
Trial summary
The study will assess the long-term safety of the fixed combination product QVA149 versus placebo and a standard of care treatment (tiotropium) in Chronic Obstructive Pulmonary Disease (COPD) patients with moderate to severe airflow limitation. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- QVA149 and Tiotropium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,215 participants
- Where
- 116 sitesin 17 countries
- Study dates
- Oct 2012to Feb 2015
- Phase
- Phase 3
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adults aged ≥40 years.
- Patients with stable COPD according to GOLD strategy (GOLD 2011).
- Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and <80% of the predicted normal, and a post-bronchodilator.
- FEV1/FVC < 0.70.
- Current or ex-smokers who have a smoking history of at least 10 pack years.
- Patients with an mMRC ≥ grade 2
Who cannot join
- History of long QT syndrome or prolonged QTc.
- Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit 1.
- Patients with Type I or uncontrolled Type II diabetes.
- Patients with a history of asthma or have concomitant pulmonary disease.
- Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible.
- Patients who have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of safety.
Trial locations and contacts
116 sites in 17 countries.
116 sites in 17 countries
Argentina25 sites
Novartis Investigative Site
Buenos Aires, Buenos Aires, 1425
Novartis Investigative Site
Buenos Aires, Buenos Aires, B1842DID
Novartis Investigative Site
Caba, Buenos Aires, 1028
Novartis Investigative Site
Caba, Buenos Aires, C1113AAC
Novartis Investigative Site
Caba, Buenos Aires, C1122AAK
Novartis Investigative Site
Caba, Buenos Aires, C1180AAX
Novartis Investigative Site
Caba, Buenos Aires, C1425AUA
Novartis Investigative Site
Concepción del Uruguay, Entre Ríos Province, E3260EPD
Novartis Investigative Site
Corrientes, Corrientes Province, W3400
Novartis Investigative Site
Florida, Buenos Aires, B1602DQD
Novartis Investigative Site
Lanus, Buenos Aires, B8000XAV
Novartis Investigative Site
Mar del Plata, Buenos Aires, B7600FZN
Novartis Investigative Site
Mendoza, Mendoza Province, 5500
Novartis Investigative Site
Mendoza, Mendoza Province, M5500CBA
Novartis Investigative Site
Quilmes, Buenos Aires, B1878FNR
Novartis Investigative Site
Rosario, Santa Fe Province, S2000AII
Novartis Investigative Site
Rosario, Santa Fe Province, S2000CXH
Novartis Investigative Site
Salta, Salta Province, 4000
Novartis Investigative Site
San Isidro, Buenos Aires, B1642DCD
Novartis Investigative Site
San Juan Bautista, Buenos Aires, B2705XAE
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, 4000
Novartis Investigative Site
Santa Fe, Rosario, S2000DBS
Novartis Investigative Site
Santa Fe, Santa Fe Province, S3000FIL
Novartis Investigative Site
Santa Fe, Santa Fe Province, S3000FWO
Novartis Investigative Site
Vicente López, Buenos Aires, B1638AAI
India14 sites
Novartis Investigative Site
Ahmedabad, India, 380009
Novartis Investigative Site
Bangalore, Karnataka, 560002
Novartis Investigative Site
Bikaner, Rajasthan, 334 001
Novartis Investigative Site
Coimbatore, Tamil Nadu, 641 045.
Novartis Investigative Site
Hyderabad, A.p., 500 001
Novartis Investigative Site
Hyderabad, Andhra Pradesh, 500004
Novartis Investigative Site
Jaipur, Rajasthan, 302 039
Novartis Investigative Site
Jaipur, Rajasthan, 302023
Novartis Investigative Site
Mysore, Karnataka, 570004
Novartis Investigative Site
Nagpur, Maharashtra, 440033
Novartis Investigative Site
Nagpur - Maharashtra, India, 440012
Novartis Investigative Site
Panjim, Goa, 403 002
Novartis Investigative Site
Trivandrum, Kerala, 695 011
Novartis Investigative Site
Vellore, Tamil Nadu, 632004
Hungary11 sites
Novartis Investigative Site
Budapest, HUN, 1204
Novartis Investigative Site
Cegléd, Hungary, 2700
Novartis Investigative Site
Csorna, H-9300
Novartis Investigative Site
Debrecen, Hungary, 4032
Novartis Investigative Site
Eger, 3300
Novartis Investigative Site
Érd, Hungary, H-2030
Novartis Investigative Site
Gödöllő, 2100
Novartis Investigative Site
Monor, Hungary, 2200
Novartis Investigative Site
Mosonmagyaróvár, 9200
Novartis Investigative Site
Siófok, Hungary, 8600
Novartis Investigative Site
Szarvas, Hungary, 5540
United Kingdom11 sites
Novartis Investigative Site
Birmingham, B15 2WB
Novartis Investigative Site
Birmingham, B9 5SS
Novartis Investigative Site
Bradford, West Yorkshire, BD9 6RJ
Novartis Investigative Site
Cheshire, CW1 4QJ
Novartis Investigative Site
Doncaster, DN2 5LT
Novartis Investigative Site
Leeds, LS9 7TF
Novartis Investigative Site
Merseyside, CH49 5PE
Novartis Investigative Site
Newport, P030 5TG
Novartis Investigative Site
Portsmouth, PO6 3AD
Novartis Investigative Site
Royal Leamington Spa, Warwickshire, CV32 4RA
Novartis Investigative Site
Wolverhampton, WV10 0QP
Russia10 sites
Novartis Investigative Site
Moscow, 115280
Novartis Investigative Site
Moscow, 125315
Novartis Investigative Site
N.Novgorod, 603126
Novartis Investigative Site
Nizhny Novgorod, 603018
Novartis Investigative Site
Ryazan, 390026
Novartis Investigative Site
Saint Petersburg, 193231
Novartis Investigative Site
Saint Petersburg, 193312
Novartis Investigative Site
Saint Petersburg, 194354
Novartis Investigative Site
Saratov, 410012
Novartis Investigative Site
Yaroslavl, 150003
South Korea8 sites
Novartis Investigative Site
Bucheon-si, Gyeonggi-do, 14584
Novartis Investigative Site
Daegu, 705-703
Novartis Investigative Site
Incheon, 403-720
Novartis Investigative Site
Incheon, 405-760
Novartis Investigative Site
Seoul, Korea, 03080
Novartis Investigative Site
Seoul, Korea, 130-709
Novartis Investigative Site
Seoul, Seoul, 156-755
Novartis Investigative Site
Seoul, 130-872
Poland5 sites
Novartis Investigative Site
Bialystok, 15-044
Novartis Investigative Site
Katowice, 40-752
Novartis Investigative Site
Krakow, 31-159
Novartis Investigative Site
Lodz, 90-153
Novartis Investigative Site
Lodz, 90-302
Turkey (Türkiye)5 sites
Novartis Investigative Site
Kartal, 34890
Novartis Investigative Site
Kocaeli, 41380
Novartis Investigative Site
Mersin, 33079
Novartis Investigative Site
Pendik / Istanbul, Turkey, 1330
Novartis Investigative Site
Yenisehir/Izmir, 35110
Colombia4 sites
Novartis Investigative Site
Armenia
Novartis Investigative Site
Barranquilla
Novartis Investigative Site
Bogota, Cundinamarca
Novartis Investigative Site
Bogotá
Croatia4 sites
Novartis Investigative Site
Osijek, 31000
Novartis Investigative Site
Sisak, Croatia, 44000
Novartis Investigative Site
Zagreb, Croatia, 10 000
Novartis Investigative Site
Zagreb, 10000
Israel4 sites
Novartis Investigative Site
Jerusalem, 91031
Novartis Investigative Site
Jerusalem, 9112001
Novartis Investigative Site
Petah Tikva, 49100
Novartis Investigative Site
Rehovot, 76100
Mexico4 sites
Novartis Investigative Site
León, Guanajuato, 37000
Novartis Investigative Site
Mexico City, Mexico City, 06726
Novartis Investigative Site
Mexico City, Mexico City, 14050
Novartis Investigative Site
Pachuca, Hidalgo, 42090
Estonia3 sites
Novartis Investigative Site
Tallinn, 13419
Novartis Investigative Site
Tallinn, 13619
Novartis Investigative Site
Tartu, Estonia, 51014
Latvia3 sites
Novartis Investigative Site
Daugavpils, LV-5401
Novartis Investigative Site
Riga, 1002
Novartis Investigative Site
Riga, LV-1038
Panama2 sites
Novartis Investigative Site
Panama City, Provincia de Panamá, 0834-00363
Novartis Investigative Site
Panama City, Provincia de Panamá
Serbia2 sites
Novartis Investigative Site
Knez-Selo, 18204
Novartis Investigative Site
Kragujevac, 34000
About this study
Official title: A Placebo and Active Controlled Study to Assess the Long-term Safety of Once Daily QVA149 for 52 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients With Moderate to Severe Airflow Limitation
The study will assess the long-term safety of the fixed combination product QVA149 versus placebo and a standard of care treatment (tiotropium) in Chronic Obstructive Pulmonary Disease (COPD) patients with moderate to severe airflow limitation.
- Being tested
- QVA149, Tiotropium, placebo
- Keywords
- chronic obstructive pulmonary disease, COPD, QVA149, QAB149, NVA237, Indacaterol maleate, Glycopyronnium bromide
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QVA149Drug
QVA149 110/50 µg will be supplied as capsules in blister packs for once daily inhalation using the Novartis Concept1 SDDPI
TiotropiumDrug
Tiotropium 18 µg will be supplied as capsules in blister packs for once daily inhalation using the HandiHaler SDDPI
placeboDrug
placebo to QVA149A and Tiotropium will be supplied in the appropriate capsule in blister packs for use in either the Novartis Concept1 SDDPI or the HandiHaler SDDPI
| Study group | Role | What they receive |
|---|---|---|
| QVA149 | Experimental | Not described Receives: Drug: QVA149 |
| Tiotropium | Active comparator | Not described Receives: Drug: Tiotropium |
| 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.
Number of Patients With Serious Adverse Events
The overall rate of serious adverse events reported from initiation through 30 days post last dose.
Measured: Week 52
Secondary outcomes (11)
Percentage of Patients With Composite Endpoint of All-cause Mortality, and Serious Cardio- and Cerebrovascular (CCV) Events.
The endpoint of all-cause mortality and serious CCV events (composite) was chosen to further characterize any discernible risks. The patients with an event in the analysis were those who had at least one of the 2 events namely, all-cause mortality and serious CCV, during treatment or within 30 days after the date of last dose of study drug.
Measured: 52 weeks
Post-hoc Analysis: Percentage of Patients With Composite Endpoint of Cardiovascular Death and MACE
The composite endpoint included all deaths and all serious CCV events, including MACE and events which were not considered MACE. A rigorous post hoc analysis was done on composite endpoint of CV deaths and major adverse cardiovascular events (MACE). The patients with an event in the analysis were those who had at least one of the 2 events namely, CV deaths and MACE, during treatment or within 30 days after the date of last dose of study drug.
Measured: 52 weeks
Change From Baseline in Pre-Dose Forced Expiratory Volume Over in Second (FEV1)
Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1.
Measured: Day 22, 43, 85, 183, 274 and 364
Change From Baseline in Health Status as Measured by St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C)
The SGRQ-C contains 40 items divided into two parts covering three aspects of health related to COPD: Part I covers "Symptoms" and is concerned with respiratory symptoms, their frequency and severity; Part II covers "Activity" and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with "Impacts" which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score will be calculated for each of these three subscales and a "Total" score will also be calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status.
Measured: Measurment at day 364
Change From Baseline in Daily, Morning and Evening Symptom Scores
Patients will be provided with an electronic diary (eDiary) to record daily clinical symptoms, or rescue medication. The patients will be instructed to routinely complete the patient diary twice daily. There are 9 total symptom questions for a total possible score of 27 at each timepoint. A higher score means the patient is reporting more symptoms related to Chronic Obstructive Pulmonary Disease. The mean daily total symptom score, the mean daytime total symptom score and the mean nighttime total symptom score were calculated for each patient over 52 weeks. Diary data recorded during the 14 day run-in period were used to calculate the baseline.
Measured: 52 weeks
Change From Baseline in Percentage of Nights With 'no Nighttime Awakenings
A night with 'no nighttime awakenings' is defined from diary data as any night where the patient did not wake up due to symptoms.
Measured: 52 weeks
Change From Baseline in Percentage of no Daytime Symptoms
A day with 'no daytime symptoms' is defined from the diary data as any day where the patient has recorded in the evening no cough, no wheeze, no production of sputum and no feeling of breathlessness (other than when running) during the past 12 hours (approx. 8 am to 8 pm).
Measured: 52 weeks
Change From Baseline in Percentage of Days Able to Perform Usual Daily Activities.
A day able to perform usual daily activities' is defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms.
Measured: 52 weeks
Change From Baseline in 1 Hour Post-dose Forced Vital Capacity (FVC) Measurements
Pulmonary function assessments were performed using centralized spirometry according to international standards
Measured: Day 1, 22, 43, 85, 183, 274 and 364
Time to Premature Discontinuation
Time to premature treatment discontinuation for each treatment group was displayed using a Kaplan-Meier curve. The date of last dose of study medication was considered as the event date and also as the censoring date for those patients who did not discontinue treatment early. The range of the 'time to treatment discontinuation' varied from 5-407 days in the Tiotropium group. Hence the model estimated lower limit of the median time to treatment discontinuation is greater than the scheduled treatment period of 52 weeks.
Measured: Time varied from 5 - 407 days
Change From Baseline in 1 Hour Post-dose FEV1 Measurements
The avg 60 min post dose forced expiratory volume in 1 second (FEV1) at visit 4, 5, 6, 7, 8 and 9 will be analyzed.
Measured: Day 1, 22, 43, 85, 183, 274 and 364
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2015
- Study completionFeb 2015
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 Chronic Obstructive Pulmonary Disease (COPD)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,215 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
- NCT01610037
- Sponsor's protocol ID
- CQVA149A2339
- Other IDs
- 2012-002057-38
- Status last verified
- May 2016
- First submitted
- 30 May 2012
- Last updated
- 15 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo and Active Controlled Study to Assess the Long-term Safety of Once Daily QVA149 for 52 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients With Moderate to Severe Airflow Limitation
- ClinicalTrials.gov ID
- NCT01610037
- Acronym / sponsor ID
- CQVA149A2339
- Keywords
- chronic obstructive pulmonary disease, COPD, QVA149, QAB149, NVA237, Indacaterol maleate, Glycopyronnium bromide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,215 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 1 Jun 2012 (estimated)
- Results
- Posted 15 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will assess the long-term safety of the fixed combination product QVA149 versus placebo and a standard of care treatment (tiotropium) in Chronic Obstructive Pulmonary Disease (COPD) patients with moderate to severe airflow limitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QVA149 | Experimental | Drug: QVA149 |
| Tiotropium | Active comparator | Drug: Tiotropium |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female adults aged ≥40 years.
- Patients with stable COPD according to GOLD strategy (GOLD 2011).
- Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and <80% of the predicted normal, and a post-bronchodilator.
- FEV1/FVC < 0.70.
- Current or ex-smokers who have a smoking history of at least 10 pack years.
Key exclusion criteria (6 listed)
- History of long QT syndrome or prolonged QTc.
- Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit 1.
- Patients with Type I or uncontrolled Type II diabetes.
- Patients with a history of asthma or have concomitant pulmonary disease.
- Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible.
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 |
|---|---|---|
| QVA149QVA149 110/50 µg will be supplied as capsules in blister packs for once daily inhalation using the Novartis Concept1 SDDPI | Drug | QVA149 |
| TiotropiumTiotropium 18 µg will be supplied as capsules in blister packs for once daily inhalation using the HandiHaler SDDPI | Drug | Tiotropium |
| placeboplacebo to QVA149A and Tiotropium will be supplied in the appropriate capsule in blister packs for use in either the Novartis Concept1 SDDPI or the HandiHaler SDDPI | Drug | placebo |
Primary outcome
Number of Patients With Serious Adverse Events
Time frame: Week 52
The overall rate of serious adverse events reported from initiation through 30 days post last dose.
11 secondary outcomes
Percentage of Patients With Composite Endpoint of All-cause Mortality, and Serious Cardio- and Cerebrovascular (CCV) Events.
Time frame: 52 weeks
Post-hoc Analysis: Percentage of Patients With Composite Endpoint of Cardiovascular Death and MACE
Time frame: 52 weeks
Change From Baseline in Pre-Dose Forced Expiratory Volume Over in Second (FEV1)
Time frame: Day 22, 43, 85, 183, 274 and 364
Change From Baseline in Health Status as Measured by St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C)
Time frame: Measurment at day 364
Change From Baseline in Daily, Morning and Evening Symptom Scores
Time frame: 52 weeks
Change From Baseline in Percentage of Nights With 'no Nighttime Awakenings
Time frame: 52 weeks
Change From Baseline in Percentage of no Daytime Symptoms
Time frame: 52 weeks
Change From Baseline in Percentage of Days Able to Perform Usual Daily Activities.
Time frame: 52 weeks
Change From Baseline in 1 Hour Post-dose Forced Vital Capacity (FVC) Measurements
Time frame: Day 1, 22, 43, 85, 183, 274 and 364
Time to Premature Discontinuation
Time frame: Time varied from 5 - 407 days
Change From Baseline in 1 Hour Post-dose FEV1 Measurements
Time frame: Day 1, 22, 43, 85, 183, 274 and 364
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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
116 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QVA149 and Tiotropium in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 116 sites in 17 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 6 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 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 116 sites in Argentina, India, Hungary, United Kingdom, Russia and 12 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 15 Jun 2016). 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?
Number of Patients With Serious Adverse Events (time frame: Week 52). 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 15 Jun 2016.