Chronic Obstructive Pulmonary Disease, COPDPhase 2NCT02449018
A Safety, Tolerability and Efficacy Study With QBW251 in COPD Patients With QBW251
A Phase 2 study testing QBW251 in people with Chronic Obstructive Pulmonary Disease, COPD, run by Novartis Pharmaceuticals at 16 sites in 2 countries.
Trial summary
To evaluate the efficacy, safety and tolerability of multiple doses of QBW251 vs placebo administered orally, on airway function, lung volume, and quality of life in patients with chronic obstructive pulmonary disease (COPD) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD
- What is being tested?
- QBW251
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 30 Apr 2015to 23 Jan 2017
- 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
Inclusion Criteria: Must have a diagnosis of GOLD II-III chronic obstructive pulmonary disease (COPD); Must have clinical diagnosis of chronic bronchitis; Must be either a current smoker (smoked ≤ 1 pack per day on average for the last 3 months with at least a 10 pack year smoking history) OR an ex-smoker with at least a 10 pack year smoking history; Exclusion Criteria: Must not be receiving chronic, daily, systemic steroids; Must not have severe emphysema (determined by HRCT); Must not have had a COPD exacerbation or respiratory tract infection requiring antibiotics or oral steroids or hospitalization within 6 weeks of screening; Must not be pregnant or nursing or a woman of child bearing potential; Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States14 sites
Novartis Investigative Site
Birmingham, Alabama, 35294
Novartis Investigative Site
Clearwater, Florida, 33765
Novartis Investigative Site
Fullerton, California, 92835
Novartis Investigative Site
Huntersville, North Carolina, 28078
Novartis Investigative Site
Medford, Oregon, 97504
Novartis Investigative Site
Normal, Illinois, 61761
Novartis Investigative Site
Port Orange, Florida, 32127
Novartis Investigative Site
Shelby, North Carolina, 28152
Novartis Investigative Site
Simpsonville, South Carolina, 29681
Novartis Investigative Site
Spartanburg, South Carolina, 29303
Novartis Investigative Site
St Louis, Missouri, 63141
Novartis Investigative Site
Tampa, Florida, 33603
Novartis Investigative Site
Union, South Carolina, 29379
Novartis Investigative Site
Waterbury, Connecticut, 06708
Poland2 sites
Novartis Investigative Site
Lodz, 90-153
Novartis Investigative Site
Sobótka, 55-050
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Multiple Doses of QBW251 in Patients With COPD
To evaluate the efficacy, safety and tolerability of multiple doses of QBW251 vs placebo administered orally, on airway function, lung volume, and quality of life in patients with chronic obstructive pulmonary disease (COPD)
- Being tested
- QBW251, Placebo
- Keywords
- COPD,, chronic bronchitis,, inflammation,, airway,, LCI,, pulmonary function test,, lung function,, controlled clinical trial,, randomized,, airflow,, smoker
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QBW251Drug
QBW251 capsule(s) taken orally twice per day
PlaceboDrug
Matching placebo capsule(s) taken orally twice per day
| Study group | Role | What they receive |
|---|---|---|
| QBW251 | Experimental | QBW251 will be provided to participants during 70 days Receives: Drug: QBW251 |
| Placebo | Placebo comparator | Placebo will be provided to participants during 70 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Lung Clearance Index (LCI)
Change from baseline to Day 29 in LCI as measured by multiple breath nitrogen washout (MBNW) technique. MBNW is the time taken to wash out nitrogen while breathing 100% oxygen.
Measured: Baseline and Day 29
Secondary outcomes (12)
Change From Baseline in FEV1 Pre-bronchodilator
Change From Baseline to Day 29 in FEV1 will be measured by spirometer before bronchodilator administration. Forced Expiratory Volume in 1 Second (FEV1) is the amount of air that can be exhaled in 1 second. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.
Measured: Day 29
Change From Baseline in FEV1 Post-bronchodilator
Change From Baseline to Day 29 in FEV1 will be measured by spirometer after bronchodilator administration. Forced Expiratory Volume in 1 Second (FEV1) is the amount of air that can be exhaled in 1 second. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.
Measured: Day 29
Change From Baseline in FVC Pre Bronchodilator
Change From Baseline to Day 29 in FVC will be measured by spirometer before bronchodilator administration. Forced Vital Capacity (FVC) is the maximum amount of air a person can expel from the lungs after a maximum inhalation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. Forced vital capacity (FVC) as a measure of lung function, measured before bronchodilator
Measured: Day 29
Change From Baseline in FVC Post- Bronchodilator
Change From Baseline to Day 29 in FVC will be measured by spirometer after bronchodilator administration. Forced Vital Capacity (FVC) is the maximum amount of air a person can expel from the lungs after a maximum inhalation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. Forced vital capacity (FVC) as a measure of lung function, measured after bronchodilator
Measured: Day 29
Change From Baseline in TLC
Change From Baseline to Day 29 in TLC will be measured by spirometry. Total lung capacity (TLC) is the volume in the lungs at maximal inflation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.
Measured: Day 29
Change From Baseline in RV
Change From Baseline to Day 29 in RV will be measured by spirometry. Residual volume (RV) is the volume of air remaining in the lungs after a maximal exhalation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.
Measured: Day 29
Change From Baseline in FRC
Change From Baseline to Day 29 in FRC will be measured by spirometry. Functional residual capacity (FRC) is the volume in the lungs at the end-expiratory position. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.
Measured: Day 29
Change From Baseline in DLCO
Diffusing capacity of the lung for carbon monoxide (DLCO) is the extent to which oxygen passes from the lung to the blood.
Measured: Day 29
Plasma Concentration of QBW251 by TMax (0-8hours)
Tmax is the time to reach the maximum concentration after drug administration.
Measured: Day 1, Day 28
Plasma Concentration of QBW251 by CMax (0-8hours)
Cmax is the observed maximum plasma concentration following drug administration.
Measured: Day 1, Day 28
Plasma Concentration of QBW251 by AUClast (0-8hours)
AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.
Measured: Day 1, Day 28
Plasma Concentration of QBW251 by AUC0-12h
AUC 0-12h is the area under the plasma concentration-time curve from time zero to 12 hours.
Measured: Day 1, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study start30 Apr 2015
- Primary completion27 Dec 2016
- Study completion23 Jan 2017
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, COPDStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 92 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
- NCT02449018
- Sponsor's protocol ID
- CQBW251X2201
- Status last verified
- Apr 2018
- First submitted
- 30 Mar 2015
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Multiple Doses of QBW251 in Patients With COPD
- ClinicalTrials.gov ID
- NCT02449018
- Acronym / sponsor ID
- CQBW251X2201
- Keywords
- COPD,, chronic bronchitis,, inflammation,, airway,, LCI,, pulmonary function test,, lung function,, controlled clinical trial,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2015 (actual)
- Primary completion
- 27 Dec 2016 (actual)
- Study completion
- 23 Jan 2017 (actual)
- First posted
- 20 May 2015 (estimated)
- Results
- Posted 2 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy, safety and tolerability of multiple doses of QBW251 vs placebo administered orally, on airway function, lung volume, and quality of life in patients with chronic obstructive pulmonary disease (COPD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QBW251 | Experimental | Drug: QBW251QBW251 will be provided to participants during 70 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be provided to participants during 70 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| QBW251QBW251 capsule(s) taken orally twice per day | Drug | QBW251 |
| PlaceboMatching placebo capsule(s) taken orally twice per day | Drug | Placebo |
Primary outcome
Change From Baseline in Lung Clearance Index (LCI)
Time frame: Baseline and Day 29
Change from baseline to Day 29 in LCI as measured by multiple breath nitrogen washout (MBNW) technique. MBNW is the time taken to wash out nitrogen while breathing 100% oxygen.
12 secondary outcomes
Change From Baseline in FEV1 Pre-bronchodilator
Time frame: Day 29
Change From Baseline in FEV1 Post-bronchodilator
Time frame: Day 29
Change From Baseline in FVC Pre Bronchodilator
Time frame: Day 29
Change From Baseline in FVC Post- Bronchodilator
Time frame: Day 29
Change From Baseline in TLC
Time frame: Day 29
Change From Baseline in RV
Time frame: Day 29
Change From Baseline in FRC
Time frame: Day 29
Change From Baseline in DLCO
Time frame: Day 29
Plasma Concentration of QBW251 by TMax (0-8hours)
Time frame: Day 1, Day 28
Plasma Concentration of QBW251 by CMax (0-8hours)
Time frame: Day 1, Day 28
Plasma Concentration of QBW251 by AUClast (0-8hours)
Time frame: Day 1, Day 28
Plasma Concentration of QBW251 by AUC0-12h
Time frame: Day 1, Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on novartisclinicatrials.comLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QBW251 in people with Chronic Obstructive Pulmonary Disease, COPD, run by Novartis Pharmaceuticals at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Poland. 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 2 Apr 2018). 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 Lung Clearance Index (LCI) (time frame: Baseline and Day 29). 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 5 Jan 2021.