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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04072887
Registration number
NCT04072887
Ethics application status
Date submitted
7/08/2019
Date registered
28/08/2019
Date last updated
28/04/2023
Titles & IDs
Public title
Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients
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Scientific title
A 24-week Multi-center, Double-blind, Placebo Controlled Dose-range Finding Study to Investigate the Efficacy and Safety of Oral QBW251 in COPD Patients on Triple Inhaled Therapy (LABA / LAMA / ICS)
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Secondary ID [1]
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2018-003197-28
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Secondary ID [2]
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CQBW251B2201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - QBW251
Treatment: Drugs - Placebo
Treatment: Drugs - COPD maintenance background therapy
Experimental: QBW251 450 mg - QBW251 was orally administered 450 mg b.i.d for 24 weeks
Experimental: QBW251 300 mg - QBW251 was orally administered 300 mg b.i.d for 24 weeks
Experimental: QBW251 150 mg - QBW251 was orally administered 150 mg b.i.d for 24 weeks
Experimental: QBW251 75 mg - QBW251 was orally administered 75 mg b.i.d for 24 weeks
Experimental: QBW251 25 mg - QBW251 was orally administered 25 mg b.i.d for 24 weeks
Placebo Comparator: Placebo - Placebo was orally administered b.i.d for 24 weeks
Treatment: Drugs: QBW251
QBW251 oral capsules (450, 300, 150, 75 and 25 mg) of identical appearance to ensure blinding administered twice a day (b.i.d) for 24 weeks
Treatment: Drugs: Placebo
Placebo oral capsules administered twice a day for 24 weeks
Treatment: Drugs: COPD maintenance background therapy
Combination of fluticasone furoate, vilanterol and umeclidinium bromide
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12
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Assessment method [1]
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The primary efficacy analysis assessed the effect of QBW251 on the absolute change from baseline in trough FEV1 in liters on Week 12. Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline measurement was defined as the baseline visit pre-bronchodilator spirometry assessment.
Change from baseline in the FEV1 mean scores were analyzed using a Mixed Model for Repeated Measures (MMRM): treatment + baseline score + smoking status at screening + run-in FEV1 + airflow limitation severity + region + time interval + treatment*time interval interaction + baseline score*time interval interaction.
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Timepoint [1]
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Baseline and Week 12
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Secondary outcome [1]
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Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
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Assessment method [1]
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The primary efficacy analysis assessed the effect of QBW251 on the absolute change from baseline in trough FEV1 in liters compared to placebo on Weeks 4, 8, 16, 20 and 24. Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline measurement was defined as the baseline visit pre-bronchodilator spirometry assessment. A positive trend for change from baseline in FEV1 across the dose range is considered a favorable outcome.
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Timepoint [1]
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Baseline, weeks 4, 8, 16, 20 and 24
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Secondary outcome [2]
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Change From Baseline in Evaluating Respiratory Symptoms (E-RS); Total Score
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Assessment method [2]
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The E-RS assesses overall daily respiratory COPD symptoms (Total score) and it is derived as the sum of 11 severity items; a higher scores indicate more severe symptoms. E-RS total score has a range of 0 to 40.
Change from baseline in the E-RS Total weekly mean scores were analyzed using a Mixed Model for Repeated Measures (MMRM): treatment + baseline score + smoking status at screening + run-in E-RS + airflow limitation severity + region + time interval + treatment*time interval interaction + baseline score*time interval interaction.
The mean baseline E-RS Total score was the average of the corresponding daily scores from the run-in period.
A negative change from baseline corresponds to improvement in symptoms severity.
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Timepoint [2]
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Baseline, weeks 12 and 24
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Secondary outcome [3]
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Change From Baseline in Evaluating Respiratory Symptoms (E-RS); Cough and Sputum Score
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Assessment method [3]
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The E-RS assesses both overall daily respiratory COPD symptoms (Total score) and specific respiratory symptoms using 3 subscales (Breathlessness, Cough & Sputum, and Chest Symptoms). The E-RS comprises 11 severity items and higher scores indicate more severe symptoms. The Cough and Sputum subscale score has a range of 0 to 11 and was derived as the sum of items 2 - 4.
Change from baseline in the E-RS Cough and Sputum weekly mean scores were analyzed using a Mixed Model for Repeated Measures (MMRM): treatment + baseline score + smoking status at screening + run-in E-RS + airflow limitation severity + region + time interval + treatment*time interval interaction + baseline score*time interval interaction.
The mean baseline E-RS Cough & Sputum subscale score was the average of the corresponding daily scores from the run-in period. Lower scores in the change from baseline correspond to lower symptom severity.
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Timepoint [3]
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Baseline, weeks 12 and 24
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Secondary outcome [4]
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Number of Participants With a "Better" Change in the Patient Global Impression of Severity (PGI-S) From Baseline
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Assessment method [4]
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The PGI-S questionnaire is a patient-reported outcomes score that rates the severity of the respiratory symptoms and of cough and mucus. The change in severity scores (Better, No change and Worse) from baseline were reported at weeks 12 and 24. Thus, the number of participants with a Better change in the severity score are reported in the table below.
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Timepoint [4]
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Baseline, weeks 12 and 24
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Secondary outcome [5]
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Change From Baseline in the Cough and Sputum Assessment Questionnaire (CASA-Q)
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Assessment method [5]
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The CASA-Q is a validated questionnaire instrument used to measure cough and sputum production, and their impact in patients COPD and/or chronic bronchitis. It contains a total of 20 items on a 5-step scale distributed in 4 domains: Cough symptoms, Cough impact, Sputum symptoms and Sputum impact. All items are rescored from 1-5 to 0-4 and then reverse scored such that better responses have higher scores. The four domains are ranged from 0-100 where higher scores associated with fewer symptoms/less impact due to cough or sputum.
Change from baseline in the CASA-Q cough and symptoms scores were analyzed using a Mixed Model for Repeated Measures (MMRM): treatment + baseline score + smoking status at screening + run-in E-RS + airflow limitation severity + region + time interval + treatment*time interval interaction + baseline score*time interval interaction.
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Timepoint [5]
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Baseline, weeks 12 and 24
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Secondary outcome [6]
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Change From Baseline in St. George's Respiratory Questionnaire (SGRQ)
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Assessment method [6]
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SGRQ measures health impairment and contains 50 items divided into three components: Symptoms, Activity and Impacts. A score was calculated for each component and a "Total" score was also calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of quality of life.
Change from baseline in the SGRQ scores were analyzed using a Mixed Model for Repeated Measures (MMRM): treatment + baseline score + smoking status at screening + baseline SGRQ score + airflow limitation severity + region + time interval + treatment*time interval interaction + baseline score*time interval interaction.
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Timepoint [6]
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Baseline, weeks 12 and 24
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Secondary outcome [7]
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Minimum Plasma Concentration (Cmin) for QBW251
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Assessment method [7]
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Venous whole blood samples were collected for pharmacokinetics characterization. Cmin was measured pre dose at all visits and was summarized using descriptive statistics. All concentrations below the lower limit of quantification (LLOQ) were treated as zero.
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Timepoint [7]
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Pre-dose on Days 15, 29, 57, 85, 113, 141 and 169
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Secondary outcome [8]
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Maximum Plasma Concentration (Cmax) for QBW251
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Assessment method [8]
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Venous whole blood samples were collected for pharmacokinetics characterization. Cmax was calculated from plasma concentration data using non-compartmental methods and summarized using descriptive statistics. Cmax was measured in the samples taken at 3 hours post-dose with the exception of the participants included in the Serial PK set on Days 1 and 15 for whom all samples (1, 2, 4, 6, and 8 hours post-dose) were taken into consideration for the measurement of Cmax. All concentrations below the lower limit of quantification (LLOQ) were treated as zero.
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Timepoint [8]
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Days 1, 15 and 169
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Secondary outcome [9]
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Maximum Plasma Concentration (Cmax) for QBW251 in Serial PK Set
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Assessment method [9]
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Venous whole blood samples were collected for pharmacokinetics characterization. Cmax was calculated from plasma concentration data using non-compartmental methods and summarized using descriptive statistics. All concentrations below the lower limit of quantification (LLOQ) were treated as zero.
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Timepoint [9]
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1, 2, 4, 6, and 8 hours post-dose on Days 1 and 15
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Secondary outcome [10]
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Area Under the Curve From Time 0 to 24 Hours (AUC0-24h) of QBW251 in Serial PK Set
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Assessment method [10]
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Venous whole blood samples were collected for pharmacokinetics characterization. AUC0-24h was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. All concentrations below the lower limit of quantification (LLOQ) were treated as zero.
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Timepoint [10]
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1, 2, 4, 6, and 8 hours post-dose on Days 1 and 15
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Eligibility
Key inclusion criteria
- Male and female COPD patients aged =40 years, who have signed an Informed Consent Form
prior to initiation of any study-related procedure.
- Current or ex-smokers who have a smoking history of at least 10 pack years.
- Patients who have been treated with a triple combination of LABA/LAMA/ICS for the last
3 months prior to screening.
- Patients featuring chronic bronchitis
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients who have had a COPD exacerbation that required treatment with antibiotics
and/or oral corticosteroids and/or hospitalization, or a respiratory tract infection
in the 4 weeks prior to screening, or between screening and randomization.
- Patients with any documented history of asthma, or with an onset of chronic
respiratory symptoms, including a COPD diagnosis, prior to age 40 years.
- Patients with a body mass index (BMI) of more than 40 kg/m2.
- Use of other investigational drugs (approved or unapproved) within 30 days or 5
half-lives prior to screening, or until the expected pharmacodynamic effect has
returned to baseline (e.g., biologics), whichever is longer; or longer if required by
local regulations.
- Pregnant or nursing (lactating) women, and women of childbearing potential not willing
to use acceptable effective methods of contraception during study participation.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/09/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2022
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Sample size
Target
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Accrual to date
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Final
974
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Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
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Recruitment hospital [1]
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Novartis Investigative Site - South Brisbane
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Recruitment hospital [2]
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Novartis Investigative Site - Clayton
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Recruitment hospital [3]
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Novartis Investigative Site - Footscray
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Recruitment hospital [4]
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Novartis Investigative Site - Spearwood
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Recruitment postcode(s) [1]
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4101 - South Brisbane
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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3011 - Footscray
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Recruitment postcode(s) [4]
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6163 - Spearwood
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Recruitment outside Australia
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Alabama
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Spain
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State/province [92]
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Andalucia
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Country [93]
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Spain
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State/province [93]
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Comunidad Valenciana
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Country [94]
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Spain
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State/province [94]
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Girona
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Country [95]
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Thailand
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State/province [95]
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Hat Yai
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Country [96]
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Thailand
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State/province [96]
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THA
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Country [97]
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Thailand
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State/province [97]
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Bangkok
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Country [98]
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Turkey
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State/province [98]
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Adana
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Country [99]
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Turkey
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State/province [99]
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Mersin
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Country [100]
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United Kingdom
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State/province [100]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
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Summary
Brief summary
This clinical study was designed to support the dose selection for future studies by
evaluating efficacy and safety of different QBW251 doses in Chronic obstructive pulmonary
disease (COPD) patients with chronic bronchitis and a history of exacerbations, compared to
placebo, when added to a triple inhaled therapy of LABA, LAMA and ICS.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04072887
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04072887
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