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Pulmonary Disease, Chronic ObstructivePhase 2NCT04072887

Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients

A Phase 2 study testing QBW251 and COPD maintenance background therapy in people with Pulmonary Disease, Chronic Obstructive, run by Novartis Pharmaceuticals at 148 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
QBW251 and COPD maintenance background therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
974 participants
Where
148 sitesin 26 countries
Study dates
12 Sep 2019to 1 Feb 2022
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

148 sites in 26 countries.

148 sites in 26 countries

Japan29 sites

  • Novartis Investigative Site

    Asahikawa, Hokkaido, 070-8644

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 104-0031

  • Novartis Investigative Site

    Chuo-ku, Tokyo, 103-0003

  • Novartis Investigative Site

    Chuo-ku, Tokyo, 103-0028

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 811-1394

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 819-8555

  • Novartis Investigative Site

    Kasuga, Fukuoka, 816-0813

  • Novartis Investigative Site

    Kawachi-Nagano, Osaka, 586-8521

  • Novartis Investigative Site

    Kawasaki, Kanagawa, 210-0852

  • Novartis Investigative Site

    Kishiwada, Osaka, 596-8501

  • Novartis Investigative Site

    Kodaira, Tokyo, 187-0024

  • Novartis Investigative Site

    Koga, Fukuoka, 811 3195

  • Novartis Investigative Site

    Matsusaka, Mie-ken, 515-8544

  • Novartis Investigative Site

    Mizunami, Gifu, 509 6134

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 457 8510

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 457-8511

  • Novartis Investigative Site

    Naka-gun, Ibaraki, 319-1113

  • Novartis Investigative Site

    Osaka, 531-0073

  • Novartis Investigative Site

    Sagamihara, Kanagawa, 252-0392

  • Novartis Investigative Site

    Sapporo, Hokkaido, 062-8618

  • Novartis Investigative Site

    Sendai, Miyagi, 983 8520

  • Novartis Investigative Site

    Setagaya-ku, Tokyo, 158-8531

  • Novartis Investigative Site

    Setagaya-Ku, Tokyo, 157-0072

  • Novartis Investigative Site

    Shinagawa, Tokyo, 140-8522

  • Novartis Investigative Site

    Toshima Ku, Tokyo, 170 0003

  • Novartis Investigative Site

    Toyonaka, Osaka, 560-8552

  • Novartis Investigative Site

    Yamagata, Yamagata, 990-8533

  • Novartis Investigative Site

    Yanagawa, Fukuoka, 832-0059

  • Novartis Investigative Site

    Yokohama, Kanagawa, 223-0059

Other trials in Japan

United States25 sites

  • Novartis Investigative Site

    Andalusia, Alabama, 36420

  • Novartis Investigative Site

    Charlotte, North Carolina, 28207

  • Novartis Investigative Site

    Columbus, Ohio, 43215

  • Novartis Investigative Site

    Crowley, Louisiana, 70526

  • Novartis Investigative Site

    Edina, Minnesota, 55435

  • Novartis Investigative Site

    El Paso, Texas, 79903

  • Novartis Investigative Site

    Florence, Kentucky, 41042

  • Novartis Investigative Site

    Gastonia, North Carolina, 28054

  • Novartis Investigative Site

    Houston, Texas, 77030

  • Novartis Investigative Site

    Livonia, Michigan, 48152

  • Novartis Investigative Site

    Los Angeles, California, 90025

  • Novartis Investigative Site

    McKinney, Texas, 75069

  • Novartis Investigative Site

    Medford, Oregon, 97504

  • Novartis Investigative Site

    Midlothian, Virginia, 23114

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55407

  • Novartis Investigative Site

    New Orleans, Louisiana, 70115

  • Novartis Investigative Site

    Omaha, Nebraska, 68134

  • Novartis Investigative Site

    Ormond Beach, Florida, 32174

  • Novartis Investigative Site

    Saint Charles, Missouri, 63301

  • Novartis Investigative Site

    Sarasota, Florida, 34233

  • Novartis Investigative Site

    Shelby, North Carolina, 28150

  • Novartis Investigative Site

    St Louis, Missouri, 63141

  • Novartis Investigative Site

    Westminster, California, 92683

  • Novartis Investigative Site

    Winter Park, Florida, 32789

  • Novartis Investigative Site

    Zachary, Louisiana, 70791

Other trials in United States

Germany14 sites

  • Novartis Investigative Site

    Berlin, 10119

  • Novartis Investigative Site

    Berlin, 12157

  • Novartis Investigative Site

    Berlin, 12159

  • Novartis Investigative Site

    Frankfurt, 60596

  • Novartis Investigative Site

    Halle, 06108

  • Novartis Investigative Site

    Hamburg, 20354

  • Novartis Investigative Site

    Landsberg, 86899

  • Novartis Investigative Site

    Leipzig, 04207

  • Novartis Investigative Site

    Leipzig, D-04299

  • Novartis Investigative Site

    Leipzig, D-04347

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Marburg, 35037

  • Novartis Investigative Site

    Mittweida, 09648

  • Novartis Investigative Site

    Witten, 58452

Other trials in Germany

Argentina10 sites

  • Novartis Investigative Site

    Berazategui, Buenos Aires, 1888

  • Novartis Investigative Site

    Ciudad Autonoma de Bs As, C1425FVH

  • Novartis Investigative Site

    Concepción del Uruguay, Entre Ríos Province, 3260

  • Novartis Investigative Site

    Mar del Plata, Buenos Aires, 7600

  • Novartis Investigative Site

    Mendoza, 5500

  • Novartis Investigative Site

    Mendoza, M5500CBA

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000AII

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DBS

  • Novartis Investigative Site

    Salta, 4000

  • Novartis Investigative Site

    Santa Fe, S3000FIL

Other trials in Argentina

Slovakia7 sites

  • Novartis Investigative Site

    Bardejov, Slovak Republic, 085 01

  • Novartis Investigative Site

    Bojnice, Slovak Republic, 972 01

  • Novartis Investigative Site

    Humenné, Slovak Republic, 066 01

  • Novartis Investigative Site

    Poprad, 058 01

  • Novartis Investigative Site

    Prešov, 080 01

  • Novartis Investigative Site

    Spišská Nová Ves, 052 01

  • Novartis Investigative Site

    Vyšné Hágy, 5984

Other trials in Slovakia

Hungary5 sites

  • Novartis Investigative Site

    Budapest, 1106

  • Novartis Investigative Site

    Gödöllő, 2100

  • Novartis Investigative Site

    Komárom, 2900

  • Novartis Investigative Site

    Makó, 6900

  • Novartis Investigative Site

    Pécs, 7635

Other trials in Hungary

Philippines5 sites

  • Novartis Investigative Site

    Bulacan, 3020

  • Novartis Investigative Site

    Iloilo City, Iloilo, 5000

  • Novartis Investigative Site

    Iloilo City, 5000

  • Novartis Investigative Site

    Lipa City, Batangas, 4217

  • Novartis Investigative Site

    Manila, 1000

Other trials in Philippines

Australia4 sites

  • Novartis Investigative Site

    Clayton, Victoria, 3168

  • Novartis Investigative Site

    Footscray, Victoria, 3011

  • Novartis Investigative Site

    South Brisbane, Queensland, 4101

  • Novartis Investigative Site

    Spearwood, Western Australia, 6163

Other trials in Australia

Czechia4 sites

  • Novartis Investigative Site

    Liberec, Czech Republic, 460 05

  • Novartis Investigative Site

    Ostrava Poruba, Czech Republic, 708 68

  • Novartis Investigative Site

    Teplice, Czech Republic, 415 01

  • Novartis Investigative Site

    Varnsdorf, 40747

Other trials in Czechia

France4 sites

  • Novartis Investigative Site

    Lyon, 69317

  • Novartis Investigative Site

    Montpellier, Herault, 34059

  • Novartis Investigative Site

    Pessac, 33604

  • Novartis Investigative Site

    Reims, 51092

Other trials in France

Thailand4 sites

  • Novartis Investigative Site

    Bangkok, 10330

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Khon Kaen, THA, 40002

  • Novartis Investigative Site

    Songkhla, Hat Yai, 90110

Other trials in Thailand

Austria3 sites

  • Novartis Investigative Site

    Feldbach, 8330

  • Novartis Investigative Site

    Grieskirchen, 4710

  • Novartis Investigative Site

    Thalheim bei Wels, 4600

Other trials in Austria

Belgium3 sites

  • Novartis Investigative Site

    Erpent, 5100

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Liège, 4000

Other trials in Belgium

Canada3 sites

  • Novartis Investigative Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • Novartis Investigative Site

    Sainte-Foy, Quebec, G1V 4G5

  • Novartis Investigative Site

    Sherwood Park, Alberta, T8H 0N2

Other trials in Canada

Denmark3 sites

  • Novartis Investigative Site

    Aalborg, DK 9000

  • Novartis Investigative Site

    Copenhagen, DK-2400

  • Novartis Investigative Site

    Hvidovre, 2650

Other trials in Denmark

Guatemala3 sites

  • Novartis Investigative Site

    Guatemala City, GTM, 01010

  • Novartis Investigative Site

    Guatemala City, GTM, 01011

  • Novartis Investigative Site

    Guatemala City, 01011

Other trials in Guatemala

Italy3 sites

  • Novartis Investigative Site

    Genova, GE, 16132

  • Novartis Investigative Site

    Negrar, VR, 37024

  • Novartis Investigative Site

    Siena, SI, 53100

Other trials in Italy

Poland3 sites

  • Novartis Investigative Site

    Grudziądz, 86-300

  • Novartis Investigative Site

    Katowice, 40-648

  • Novartis Investigative Site

    Zawadzkie, 47-120

Other trials in Poland

South Korea3 sites

  • Novartis Investigative Site

    Daegu, 705703

  • Novartis Investigative Site

    Incheon, 21431

  • Novartis Investigative Site

    Seoul, Seocho Gu, 06591

Other trials in South Korea

Spain3 sites

  • Novartis Investigative Site

    Alzira, Valencia, 46600

  • Novartis Investigative Site

    Girona, 17005

  • Novartis Investigative Site

    Marbella, Andalusia, 29603

Other trials in Spain

Greece2 sites

  • Novartis Investigative Site

    Heraklion Crete, Greece, 711 10

  • Novartis Investigative Site

    Thessaloniki, GR, 570 10

Other trials in Greece

Hong Kong2 sites

  • Novartis Investigative Site

    New Territories, Hong Kong

  • Novartis Investigative Site

    Pokfulam, Hong Kong

Other trials in Hong Kong

Netherlands2 sites

  • Novartis Investigative Site

    Eindhoven, 5623 EJ

  • Novartis Investigative Site

    Harderwijk, 3840 AC

Other trials in Netherlands

Turkey (Türkiye)2 sites

  • Novartis Investigative Site

    Adana, 01330

  • Novartis Investigative Site

    Mersin, 33079

Other trials in Turkey (Türkiye)

Colombia1 site

  • Novartis Investigative Site

    Zipaquirá, Cundinamarca, 250252

Other trials in Colombia

United Kingdom1 site

  • Novartis Investigative Site

    London, EC1A 7BE

Other trials in United Kingdom

About this study

Official 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)

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.

Read the detailed description

This study used a 6 treatment arm, parallel-group, randomized, double-blind study design. 974 male and female COPD patients were randomized into the trial. The study consisted of four distinct study periods:

  • Screening (Weeks -3 to -2): Participants underwent a screening period of 1 week where were assessed for eligibility and tapered off disallowed medications.
  • Run-in (Days -14 to 1): Subsequently, participants entered the run-in period of up to 2 weeks to establish baseline values for symptom assessments, to standardize the COPD background therapy (triple combination LABA/LAMA/ICS), and to complete eligibility assessments.
  • Treatment (Day 1 to Week 24): Eligible participants moved into the Day 1 visit where they were stratified according to their smoking status (current or ex-smoker) and severity of airflow limitation (FEV1 ≥ 30% to < 50% and ≥ 50% to < 80%) and then randomized into 1 of 6 treatment arms with a randomization ratio of 2:2:1:1:1:2 (450 mg b.i.d., 300 mg b.i.d., 150 mg b.i.d., 75 mg b.i.d., 25 mg b.i.d., placebo). The treatment period consisted of 24 weeks, during which the participant returned to the site for regular visits (Day 1 - Week 24). QBW251 450 mg arm was discontinued early based on a pre-defined pharmacokinetic exposure stopping rule.
  • Follow-up (Weeks 25-28): Upon completion of the treatment period, participants were followed up for safety assessments for 30 days.
Being tested
QBW251, Placebo, COPD maintenance background therapy
Keywords
COPD
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.

  • QBW251Drug

    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

  • PlaceboDrug

    Placebo oral capsules administered twice a day for 24 weeks

  • COPD maintenance background therapyDrug

    Combination of fluticasone furoate, vilanterol and umeclidinium bromide

Study groups in NCT04072887
Study groupRoleWhat they receive
QBW251 450 mgExperimentalQBW251 was orally administered 450 mg b.i.d for 24 weeks
Receives: Drug: QBW251; Drug: COPD maintenance background therapy
QBW251 300 mgExperimentalQBW251 was orally administered 300 mg b.i.d for 24 weeks
Receives: Drug: QBW251; Drug: COPD maintenance background therapy
QBW251 150 mgExperimentalQBW251 was orally administered 150 mg b.i.d for 24 weeks
Receives: Drug: QBW251; Drug: COPD maintenance background therapy
QBW251 75 mgExperimentalQBW251 was orally administered 75 mg b.i.d for 24 weeks
Receives: Drug: QBW251; Drug: COPD maintenance background therapy
QBW251 25 mgExperimentalQBW251 was orally administered 25 mg b.i.d for 24 weeks
Receives: Drug: QBW251; Drug: COPD maintenance background therapy
PlaceboPlacebo comparatorPlacebo was orally administered b.i.d for 24 weeks
Receives: Drug: Placebo; Drug: COPD maintenance background therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12

    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.

    Measured: Baseline and Week 12

Secondary outcomes (10)

  1. Change From Baseline in Forced Expiratory Volume in One Second (FEV1)

    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.

    Measured: Baseline, weeks 4, 8, 16, 20 and 24

  2. Change From Baseline in Evaluating Respiratory Symptoms (E-RS); Total Score

    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.

    Measured: Baseline, weeks 12 and 24

  3. Change From Baseline in Evaluating Respiratory Symptoms (E-RS); Cough and Sputum Score

    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.

    Measured: Baseline, weeks 12 and 24

  4. Number of Participants With a "Better" Change in the Patient Global Impression of Severity (PGI-S) From Baseline

    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.

    Measured: Baseline, weeks 12 and 24

  5. Change From Baseline in the Cough and Sputum Assessment Questionnaire (CASA-Q)

    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.

    Measured: Baseline, weeks 12 and 24

  6. Change From Baseline in St. George's Respiratory Questionnaire (SGRQ)

    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.

    Measured: Baseline, weeks 12 and 24

  7. Minimum Plasma Concentration (Cmin) for QBW251

    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.

    Measured: Pre-dose on Days 15, 29, 57, 85, 113, 141 and 169

  8. Maximum Plasma Concentration (Cmax) for QBW251

    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.

    Measured: Days 1, 15 and 169

  9. Maximum Plasma Concentration (Cmax) for QBW251 in Serial PK Set

    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.

    Measured: 1, 2, 4, 6, and 8 hours post-dose on Days 1 and 15

  10. Area Under the Curve From Time 0 to 24 Hours (AUC0-24h) of QBW251 in Serial PK Set

    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.

    Measured: 1, 2, 4, 6, and 8 hours post-dose on Days 1 and 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start12 Sep 2019
  3. Primary completion8 Oct 2021
  4. Study completion1 Feb 2022

Resources

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, Care provider, Investigator
Enrolment
974 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04072887
Sponsor's protocol ID
CQBW251B2201
Other IDs
2018-003197-28, 2018
Status last verified
Apr 2023
First submitted
7 Aug 2019
Last updated
28 Apr 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Martinez FJ, Criner GJ, Gessner C, Jandl M, Scherbovsky F, Shinkai M, Siler TM, Vogelmeier CF, Voves R, Wedzicha JA, Bartels C, Bottoli I, Byiers S, Cardenas P, Eckert JH, Gutzwiller FS, Knorr B, Kothari M, Parlikar R, Tanase AM, Franssen FME. Icenticaftor, a CFTR Potentiator, in COPD: A Multicenter, Parallel-Group, Double-Blind Clinical Trial. Am J Respir Crit Care Med. 2023 Aug 15;208(4):417-427. doi: 10.1164/rccm.202303-0458OC.

    PubMed 37411039

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QBW251 and COPD maintenance background therapy in people with Pulmonary Disease, Chronic Obstructive, run by Novartis Pharmaceuticals at 148 sites in 26 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 4 inclusion and 5 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 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 148 sites in Japan, United States, Germany, Argentina, Slovakia and 21 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 28 Apr 2023). 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 Forced Expiratory Volume in One Second (FEV1) at Week 12 (time frame: Baseline and Week 12). 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 NCT04072887, 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 28 Apr 2023.

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