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 |
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.
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.)
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