A 24-week study to investigate dose, efficacy and safety of QBW251 in patients with chronic obstructive airways disease, given on top of triple inhaled therapy (LABA/LAMA/inhaled corticosteroids)
- Conditions
- Chronic obstructive pulmonary diseaseMedDRA version: 21.1Level: LLTClassification code 10029972Term: Obstructive airways disease (chronic)System Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2018-003197-28-GR
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 956
• 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 478
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 478
• 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method