Chronic Obstructive Pulmonary DiseasePhase 3BLAZENCT01490125
The Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing QVA149, Tiotropium and Salbutamol/albuterol in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 43 sites in 5 countries.
Trial summary
This study assessed the effect of QVA149 on patient-reported dyspnea in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- QVA149, Tiotropium and Salbutamol/albuterol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 247 participants
- Where
- 43 sitesin 5 countries
- Study dates
- Oct 2011to Aug 2012
- 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
- Patients with moderate to severe stable chronic obstructive pulmonary disease
- Smoking history of 10 pack years
- Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) between 30 - 80%
- Patients must be able to use computer mouse and display
- mMRC grade>2
Who cannot join
- Patients with a history of long QT syndrome
- Patients with Type I or uncontrolled Type II diabetes
- Patients who have had a COPD exacerbation or respiratory tract infection within 6 weeks prior to screening
- Patients with any history of asthma
- Patients with pulmonary lobectomy, lung volume reduction surgery, or lung transplantation
- Patients with concomitant pulmonary disease
- Patients requiring long term oxygen therapy (>15 h a day)
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
43 sites in 5 countries.
43 sites in 5 countries
Germany18 sites
Novartis Investigative Site
Aschaffenburg, 63739
Novartis Investigative Site
Berlin, Germany, 12099
Novartis Investigative Site
Berlin, 10789
Novartis Investigative Site
Berlin, 12203
Novartis Investigative Site
Berlin, 13156
Novartis Investigative Site
Cottbus, Saxony, 03050
Novartis Investigative Site
Frankfurt, 60389
Novartis Investigative Site
Halle, 06108
Novartis Investigative Site
Hanover, 30317
Novartis Investigative Site
Leipzig, Germany, 04207
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
Leipzig, 04275
Novartis Investigative Site
Leipzig, 04357
Novartis Investigative Site
Mainz, Germany, D-55101
Novartis Investigative Site
Potsdam, Germany, 14467
Novartis Investigative Site
Potsdam, 14478
Novartis Investigative Site
Rheine, 48431
Novartis Investigative Site
Rüdersdorf, 15562
Belgium8 sites
Novartis Investigative Site
Brussels, 1000
Novartis Investigative Site
Gilly, 6060
Novartis Investigative Site
Jambes, 5100
Novartis Investigative Site
Jette, 1090
Novartis Investigative Site
Leuven, 3000
Novartis Investigative Site
Liège, 4000
Novartis Investigative Site
Ostend, 8400
Novartis Investigative Site
Wavre, 1301
Canada7 sites
Novartis Investigative Site
Burlington, Ontario, L7N 3V2
Novartis Investigative Site
Laval, Quebec, H7S 2M5
Novartis Investigative Site
Mirabel, Quebec, J7J 2K8
Novartis Investigative Site
Mississauga, Ontario, L5M 2V8
Novartis Investigative Site
Saint-Charles-Borromée, Quebec, J6E 6J2
Novartis Investigative Site
Toronto, Ontario, M5G1N8
Novartis Investigative Site
Toronto, Ontario, M6H 3M2
Spain5 sites
Novartis Investigative Site
Badalona, Barcelona, 08914
Novartis Investigative Site
Madrid, Madrid, 28007
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Mérida, Badajoz, 06800
Novartis Investigative Site
Ponferrada, Leon, 24400
United Kingdom5 sites
Novartis Investigative Site
Bradford, BD9 6RJ
Novartis Investigative Site
Glasgow, G11 6NT
Novartis Investigative Site
Newcastle upon Tyne, NE7 7DN
Novartis Investigative Site
Portsmouth, PO6 3AD
Novartis Investigative Site
Salford, Manchester, M6 8HD
About this study
Official title: A Multicenter, Randomized, Blinded, Double-dummy, Placebo-controlled, 3-period Cross-over Study to Evaluate the Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control
This study assessed the effect of QVA149 on patient-reported dyspnea in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.
Read the detailed description
This study used a multi-center, randomized, blinded, double-dummy placebo controlled, three-period crossover design to assess the effect of once daily QVA149 q.d vs. placebo and tiotropium 18 μg q.d. in terms of patient reported dyspnea as assessed by Baseline Dyspnea Index (BDI)/Transient Dyspnea Index (TDI)(SAC version) in patients with moderate to severe COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- QVA149, Tiotropium, Placebo to QVA149, Placebo to tiotropium, Salbutamol/albuterol
- Keywords
- COPD, Dyspnea, QVA149, tiotropium
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QVA149Drug
QVA149 110/50 μg hard non-gelatin capsule, inhalation/blister once a day via SDDPI
TiotropiumDrug
Tiotropium 18 ug hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device
Placebo to QVA149Drug
Placebo 0 mg hard non-gelatin capsule, inhalation/ blister once a day via SDDPI
Placebo to tiotropiumDrug
Placebo 0 mg hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device
Salbutamol/albuterolDrug
salbutamol/albuterol (containing CFC-free propellant -HFA 134a) inhaler used as rescue medication when needed.
| Study group | Role | What they receive |
|---|---|---|
| QVA149 + placebo to tiotropium | Experimental | Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication. Receives: Drug: QVA149; Drug: Placebo to tiotropium; Drug: Salbutamol/albuterol |
| Tiotropium + placebo to QVA149 | Active comparator | Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication. Receives: Drug: Tiotropium; Drug: Placebo to QVA149; Drug: Salbutamol/albuterol |
| Placebo | Placebo comparator | Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication. Receives: Drug: Placebo to QVA149; Drug: Placebo to tiotropium; Drug: Salbutamol/albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo
Total Transient Dyspnea Index (TDI) is part of the BDI/TDI questionnaire where participants indicated whether they improved or deteriorated since their Baseline Dyspnea Index (BDI). The BDI and TDI each had 3 domains: activities, tasks, and effort. BDI domains were rated from 0 (very severe) to 4 (none) and the rates summed for the total BDI score ranging from 0 to 12; the lower the score the worse the severity of dyspnea. TDI domains were rated from -6 (major deterioration) to 6 (major improvement) and the rates summed for the total TDI score ranging from -18 to 18. However, to ensure comparability with the TDI paper version, all TDI values were divided by 2 before the analysis. If data was missing or insufficient for any one of the domains a BDI/TDI was calculated. BDI = Baseline Dyspnea Index taken 75 min prior to the first dose in each treatment period. TDI = Transition Dyspnea Index taken after 6 weeks of treatment 75 min prior to the last dose in each treatment period.
Measured: Baseline and 6 weeks
Secondary outcomes (5)
Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Tiotropium
Total Transient Dyspnea Index (TDI) is part of the BDI/TDI questionnaire where participants indicated whether they improved or deteriorated since their Baseline Dyspnea Index (BDI). The BDI and TDI each had 3 domains: activities, tasks, and effort. BDI domains were rated from 0 (very severe) to 4 (none) and the rates summed for the total BDI score ranging from 0 to 12; the lower the score the worse the severity of dyspnea. TDI domains were rated from -6 (major deterioration) to 6 (major improvement) and the rates summed for the total TDI score ranging from -18 to 18. However, to ensure comparability with the TDI paper version, all TDI values were divided by 2 before the analysis. If data was missing or insufficient for any one of the domains a BDI/TDI was calculated. BDI = Baseline Dyspnea Index taken 75 min prior to the first dose in each treatment period. TDI = Transition Dyspnea Index taken after 6 weeks of treatment 75 min prior to the last dose in each treatment period.
Measured: Baseline and 6 weeks
Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 5min-4h After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium
Forced Expiratory Volume in 1 second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were taken at 5 min- 4hr post-dose of day 1 and week 6. The standardized FEV1 Area under the curve (AUC) was calculated as the sum of trapezoids divided by the length of time.
Measured: 5min-4hr at day 1 and week 6 post-dose
Standardized Forced Vital Capacity (FVC) Area Under the Curve (AUC) 5min-4 Hrs After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium
Forced Vital Capacity (FVC) is the total amount of air that can be exhaled by the patient after a full inhalation. The FVC was measured via spirometry conducted according to internationally accepted standards at 5 min-4 hr post dose of day 1 and week 6.
Measured: 5min-4hr at day 1 and week 6 post-dose
Change From Baseline in The Capacity of Daily Living During the Morning (CDLM) Score Averaged Over 6 Weeks of Treatment
The Capacity of Daily Living during the Morning (CDLM) is a self-administered daily assessment. The CDLM asks COPD patients to (i) report their ability to carry out 6 morning activities and (ii) rate the difficulty in performing those activities on a five point Likert-type scale ranging from "not at all difficult" to "extremely difficult". For each of the six morning activities a score ranging from 0 (=so difficult that they could not carry out the activity by themselves) to 5 (not at all difficult to carry out the activity by themselves) is calculated by using the responses from the two questions for each activity. Daily CDLM is calculated using the scores average from the 6 morning activities. CDLM is calculated as the average daily CDLM score over 6 weeks of treatment. The change from baseline in CDLM score over 6 weeks is analyzed using a MIXED model with baseline CDLM score as a covariate. A CDLM score of 0.20 is considered to be a minimal clinically important difference.
Measured: Baseline and 6 weeks
Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Used Over the 6 Weeks of Treatment
The number of puffs of rescue medication taken by participants, were collected each day during the study via entries in e-diaries
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2012
- Study completionAug 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 247 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
- NCT01490125
- Sponsor's protocol ID
- CQVA149A2322
- Other IDs
- 2011-000229-63
- Acronym
- BLAZE
- Status last verified
- Nov 2013
- First submitted
- 15 Nov 2011
- Last updated
- 24 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mahler DA, Decramer M, D'Urzo A, Worth H, White T, Alagappan VK, Chen H, Gallagher N, Kulich K, Banerji D. Dual bronchodilation with QVA149 reduces patient-reported dyspnoea in COPD: the BLAZE study. Eur Respir J. 2014 Jun;43(6):1599-609. doi: 10.1183/09031936.00124013. Epub 2013 Oct 31.
PubMed 24176997
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Blinded, Double-dummy, Placebo-controlled, 3-period Cross-over Study to Evaluate the Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control
- ClinicalTrials.gov ID
- NCT01490125
- Acronym / sponsor ID
- BLAZE / CQVA149A2322
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Dyspnea, QVA149, tiotropium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 12 Dec 2011 (estimated)
- Results
- Posted 24 Dec 2013
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 of QVA149 on patient-reported dyspnea in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.
Detailed description
This study used a multi-center, randomized, blinded, double-dummy placebo controlled, three-period crossover design to assess the effect of once daily QVA149 q.d vs. placebo and tiotropium 18 μg q.d. in terms of patient reported dyspnea as assessed by Baseline Dyspnea Index (BDI)/Transient Dyspnea Index (TDI)(SAC version) in patients with moderate to severe COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QVA149 + placebo to tiotropium | Experimental | Drug: QVA149, Drug: Placebo to tiotropium, Drug: Salbutamol/albuterolParticipants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication. |
| Tiotropium + placebo to QVA149 | Active comparator | Drug: Tiotropium, Drug: Placebo to QVA149, Drug: Salbutamol/albuterolParticipants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication. |
| Placebo | Placebo comparator | Drug: Placebo to QVA149, Drug: Placebo to tiotropium, Drug: Salbutamol/albuterolParticipants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with moderate to severe stable chronic obstructive pulmonary disease
- Smoking history of 10 pack years
- Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) between 30 - 80%
- Patients must be able to use computer mouse and display
- mMRC grade>2
Key exclusion criteria (8 listed)
- Patients with a history of long QT syndrome
- Patients with Type I or uncontrolled Type II diabetes
- Patients who have had a COPD exacerbation or respiratory tract infection within 6 weeks prior to screening
- Patients with any history of asthma
- Patients with pulmonary lobectomy, lung volume reduction surgery, or lung transplantation
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 hard non-gelatin capsule, inhalation/blister once a day via SDDPI | Drug | QVA149 + placebo to tiotropium |
| TiotropiumTiotropium 18 ug hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device | Drug | Tiotropium + placebo to QVA149 |
| Placebo to QVA149Placebo 0 mg hard non-gelatin capsule, inhalation/ blister once a day via SDDPI | Drug | Placebo, Tiotropium + placebo to QVA149 |
| Placebo to tiotropiumPlacebo 0 mg hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device | Drug | Placebo, QVA149 + placebo to tiotropium |
| Salbutamol/albuterolsalbutamol/albuterol (containing CFC-free propellant -HFA 134a) inhaler used as rescue medication when needed. | Drug | Placebo, QVA149 + placebo to tiotropium, Tiotropium + placebo to QVA149 |
Primary outcome
Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo
Time frame: Baseline and 6 weeks
Total Transient Dyspnea Index (TDI) is part of the BDI/TDI questionnaire where participants indicated whether they improved or deteriorated since their Baseline Dyspnea Index (BDI). The BDI and TDI each had 3 domains: activities, tasks, and effort. BDI domains were rated from 0 (very severe) to 4 (none) and the rates summed for the total BDI score ranging from 0 to 12; the lower the score the worse the severity of dyspnea. TDI domains were rated from -6 (major deterioration) to 6 (major improvement) and the rates summed for the total TDI score ranging from -18 to 18. However, to ensure comparability with the TDI paper version, all TDI values were divided by 2 before the analysis. If data was missing or insufficient for any one of the domains a BDI/TDI was calculated. BDI = Baseline Dyspnea Index taken 75 min prior to the first dose in each treatment period. TDI = Transition Dyspnea Index taken after 6 weeks of treatment 75 min prior to the last dose in each treatment period.
5 secondary outcomes
Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Tiotropium
Time frame: Baseline and 6 weeks
Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 5min-4h After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium
Time frame: 5min-4hr at day 1 and week 6 post-dose
Standardized Forced Vital Capacity (FVC) Area Under the Curve (AUC) 5min-4 Hrs After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium
Time frame: 5min-4hr at day 1 and week 6 post-dose
Change From Baseline in The Capacity of Daily Living During the Morning (CDLM) Score Averaged Over 6 Weeks of Treatment
Time frame: Baseline and 6 weeks
Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Used Over the 6 Weeks of Treatment
Time frame: Baseline and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24176997Mahler DA, Decramer M, D'Urzo A, Worth H, White T, Alagappan VK, Chen H, Gallagher N, Kulich K, Banerji D. Dual bronchodilation with QVA149 reduces patient-reported dyspnoea in COPD: the BLAZE study. Eur Respir J. 2014 Jun;43(6):1599-609. doi: 10.1183/09031936.00124013. Epub 2013 Oct 31.
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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
43 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QVA149, Tiotropium and Salbutamol/albuterol in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 43 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 5 inclusion and 8 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 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in Germany, Belgium, Canada, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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 24 Dec 2013). 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?
Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo (time frame: Baseline and 6 weeks). 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 NCT01490125, 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 24 Dec 2013.