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



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:10/21/2018
Start Date:September 27, 2017
End Date:January 1, 2019
Contact:Novartis Pharmaceuticals
Email:trialandresults.registries@novartis.com
Phone:1-888-669-6682

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A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Inhaled QBW276 in Patients With Cystic Fibrosis

This is a study of multiple doses of inhaled QBW276 in patients with cystic fibrosis on top
of standard of care. The study will be 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.

In contrast, cohort 3 is a randomized, double-blind, placebo-controlled, cross-over design,
multiple dose study to assess the efficacy, safety, tolerability and pharmacokinetics of
inhaled QBW276 over 4 weeks in patients with cystic fibrosis who are homozygous for the
F508del mutation.


Inclusion Criteria:

- 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%

Exclusion Criteria:

- Adrenal or electrolyte abnormalities

- Lung transplant

- Autonomic dysfunction (e.g. recurrent episodes of fainting, palpitations, etc.)
We found this trial at
3
sites
Dallas, Texas 75216
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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