A randomized, subject- and investigator-blinded, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in patients with bronchiectasis

ovartis Pharma AG0 sites72 target enrollmentOctober 1, 2020

ConditionsBronchiectasis MedDRA version: 23.0Level: LLTClassification code 10083611Term: Non-cystic fibrosis bronchiectasisSystem Organ Class: 100000004855 Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Bronchiectasis
Sponsor: ovartis Pharma AG
Enrollment: 72
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 1, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ovartis Pharma AG

Eligibility Criteria

Inclusion Criteria

•\-Written informed consent must be obtained before any assessment is performed.
•\-Male or female patients aged \=18 years at screening.
•\-Proven diagnosis of bronchiectasis by chest CT at screening as determined by the investigator. The screening HRCT can be used to
•confirm the diagnosis if no historical chest CT is available.
•\-Evidence of sputum bacterial load of \=10^6 CFU/mL with at least one
•potentially pathogenic microorganism at screening (H. Influenzae, M
•catarrhalis, S aureus, S pneumoniae, Enterobacteriaceae, P aeruginosa, Stenotrophomonous maltophilia, or any potential pathogenic nonfermenting Gram negative bacteria measured by dilution/outgrowth.)
•NOTE: H. parainfluenzae is not considered pathogenic in this study
•and therefore growth of this organism alone does not satisfy this criterion.
•\-Documented history of at least one bronchiectasis exacerbation

Exclusion Criteria

•\-Use of other investigational drugs at the time of enrollment, or within 5 half\-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations. Current or planned participation in another clinical trial during this study
•\- History of hypersensitivity to the study drugs or to drugs of similar chemical classes or excipients
•\-Patients with a history of long\-QT syndrome or the QTcF interval at Screening or baseline is prolonged (QTcF \>450 ms in males, \>460 ms in females)
•\-Patients who have a clinically significant ECG abnormality before randomization, as determined by investigator. Note: Clinically significant abnormalities may include but are not limited to the following: left bundle branch block, Wolff\-Parkinson\-White syndrome, clinically significant arrhythmias (e.g. atrial fibrillation, ventricular tachycardia)
•\-Patients with a history or current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure. A history of resolved Hepatitis A is not exclusionary. Patients with prothrombin time international normalized ratio(PT/INR) of more than 1\.5xULN at screening. Patients excluded for the PT/INR of more than 1\.5xULN can be re\-screened when the values have returned to normal
•\-History of lung transplant or malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Patients with segmentectomy for other reasons than cancer are allowed to be included in the study. Patients with a history of cancer and 5 years or more disease\-free survival time may be included in the study by agreement with Novartis Medical Monitor on a case\-by\-case basis
•\-Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory blood test
•\-Women of child\-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using acceptable effective methods of contraception during study participation
•\-Clinically significant laboratory values abnormalities (including G\-GT, AST, ALT, total bilirubin or creatinine) in the opinion of the investigator at screening
•\-Patients requiring long\-term oxygen therapy for chronic hypoxemia. This is typically patients requiring oxygen therapy \>12 h per day delivered by home oxygen cylinder or concentrator. Note: Nocturnal oxygen therapy for transient oxygen desaturations during sleep is allowed