Safety, Pharmacokinetics and Pharmacodynamics Study of Inhaled QBW276 in Patients With Cystic Fibrosis

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Pulmonary Cystic Fibrosis

In brief

This is a study of multiple doses of inhaled QBW276 in patients with cystic fibrosis on top of standard of care. The study was divided into 3 Cohorts. Cohorts 1 and 2 are designed to be a randomized, double-blind, placebo-controlled, parallel arm, multiple dose study to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of inhaled QBW276 over 1 week (cohort 1) or 2 weeks (cohort 2) in patients with cystic fibrosis regardless of their genotype. The study was terminated after Cohort 2 due to the resource issues.

Key facts

Study ID

NCT02566044

Run by

Novartis Pharmaceuticals

People needed

16

Starts

2017-09-27

Expected to finish

2018-04-24

Last updated by the study team

2020-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cohorts 1 and 2 = any genotype on any standard of care treatment
• Cohort 3 = F508del homozygotes on standard of care at that time
• FEV₁between 40 and 100%
• LCI2.5 ≥ 8 if FEV₁is more than 80%

You may not qualify if…

• Adrenal or electrolyte abnormalities
• Lung transplant
• Autonomic dysfunction (e.g. recurrent episodes of fainting, palpitations, etc.)

Where it is running

• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Cologne, Germany
• Novartis Investigative Site — Essen, Germany

Full record on ClinicalTrials.gov

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