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)
- Conditions
- Chronic Obstructive Pulmonary DiseaseCOPD10038716
- Registration Number
- NL-OMON50119
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
* 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.
* A COPD Assessment Test (CAT) score of at least 10 at Run-In 1 visit.
* Patients with a post-bronchodilator FEV1/FVC <0.70 at Run-In 1 visit.
* Patients with airflow limitation indicated by EITHER a post-bronchodilator
FEV1 * 30 % and FEV1 < 50 % of the predicted normal at Run-in 1, who must have
had at least 1 documented moderate or severe healthcare resource utilization
(HCRU) exacerbation in the 12 months prior to study entry (screening), OR a
post-bronchodilator FEV1 * 50 % and <80 % of the predicted normal at Run-In 1,
who must have had at least 2 documented moderate or at least 1 documented
severe HCRU exacerbation(s) in the 12 months prior to study entry (screening)
* Patients featuring chronic bronchitis, defined by the presence of cough and
bronchial hypersecretion, that occurs for at least three consecutive months in
each of two consecutive years prior to study entry (screening), documented in
patient history.
* Patients who have a history of long-QT syndrome, a clinically significant ECG
abnormality at
baseline, or whose QTc measured at baseline is prolonged.
* Patients who have clinically significant renal, cardiovascular, neurological,
endocrine,
immunological, psychiatric, gastrointestinal, or hematological abnormalities,
which could interfere
with the assessment of the efficacy and safety of the study treatment, with a
clinically significant laboratory abnormality at baseline, or patients with
Type I diabetes or uncontrolled Type II diabetes.
* 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to characterize the dose-response<br /><br>relationship of QBW251 administered orally over 12 weeks on lung function,<br /><br>compared to placebo, when added to inhaled triple combination therapy<br /><br>(LABA/LAMA/ICS). Trough forced expiratory volume in one second (FEV1) will be<br /><br>assessed at Week 12 and evaluated as change from baseline after 12 weeks of<br /><br>treatment.</p><br>
- Secondary Outcome Measures
Name Time Method