Phase
Condition
Cystic Fibrosis
Lung Disease
Scar Tissue
Treatment
N/AClinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Homozygous for the F508del CFTR mutation
Confirmed diagnosis of CF
Percent predicted forced expiratory volume (ppFEV1) ≥70% of predicted normal for age,sex, and height during screening.
Stable CF disease as judged by the investigator
Exclusion
Exclusion Criteria:
History of any comorbidity that, in the opinion of the investigator, might confoundthe results of the study or pose an additional risk in administering study drug to thesubject.
An acute upper or lower respiratory infection, pulmonary exacerbation, or changes intherapy (including antibiotics) for pulmonary disease within 28 days before Day 1 (first dose of study drug)
Pregnant or nursing females.
Sexually active subjects of reproductive potential who are not willing to follow thecontraception requirements.
Any contraindication to undergoing chest imaging, as per the site's institutionalguidelines
Study Design
Connect with a study center
Chermside,
AustraliaSite Not Available
Melbourne,
AustraliaSite Not Available
Nedlands,
AustraliaSite Not Available
New Lambton Heights,
AustraliaSite Not Available
Parkville SIC,
AustraliaSite Not Available
Randwick,
AustraliaSite Not Available
South Brisbane,
AustraliaSite Not Available
Subiaco,
AustraliaSite Not Available
Westmead,
AustraliaSite Not Available

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