Phase 2
Completed N=974
Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT04072887 ↗
Enrolled (actual)
974
Serious AEs
9.2%
Results posted
Apr 2023
Primary outcomePrimary: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12 — 0.013; 0.013; 0.014; 0.021 Liter — p=0.628
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12 |
0.013; 0.013; 0.014; 0.021; 0.006; 0.001 | 0.628 |
| SECONDARY Change From Baseline in Forced Expiratory Volume in One Second (FEV1) |
0.007; 0.007; 0.009; 0.000; 0.009; 0.005 | — |
| SECONDARY Change From Baseline in Evaluating Respiratory Symptoms (E-RS); Total Score |
-1.75; -1.26; -1.66; -1.30; -1.41; -2.16 | — |
| SECONDARY Change From Baseline in Evaluating Respiratory Symptoms (E-RS); Cough and Sputum Score |
-0.78; -0.63; -0.52; -0.22; -0.44; -0.90 | — |
| SECONDARY Number of Participants With a "Better" Change in the Patient Global Impression of Severity (PGI-S) From Baseline |
66; 27; 35; 33; 64; 72 | — |
| SECONDARY Change From Baseline in the Cough and Sputum Assessment Questionnaire (CASA-Q) |
6.06; 8.82; 6.68; 6.73; 6.06; 10.49 | — |
| SECONDARY Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) |
-0.34; -5.84; -3.14; -6.78; -3.85; -3.36 | — |
| SECONDARY Minimum Plasma Concentration (Cmin) for QBW251 |
1280; 619; 143; 44.0; 12.7; 951 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) for QBW251 |
1280; 751; 251; 68.9; 14.4; 2500 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) for QBW251 in Serial PK Set |
1510; 1280; 478; 96.6; 25.3; 2700 | — |
| SECONDARY Area Under the Curve From Time 0 to 24 Hours (AUC0-24h) of QBW251 in Serial PK Set |
10900; 8480; 2920; 769; 185; 30000 | — |
Eligibility Criteria
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
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.
Data sourced from ClinicalTrials.gov (NCT04072887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.