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Sildenafil Exercise: Role of PDE5 Inhibition

NCT04039087 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-09-19

No results posted yet for this study

Summary

Exercise intolerance is an understudied phenomenon in people with CF. The investigators hypothesized that vascular dysfunction plays a significant role, and can be partially reversed by administration of the phosphodiesterase type 5 (PDE5) inhibitor, sildenafil.

Conditions

Interventions

DRUG

Sildenafil 40mg oral capsule

40 mg, sildenafil capsule taken by mouth thrice daily

DRUG

Placebo Oral capsule

Placebo capsule taken by mouth thrice daily

Sponsors & Collaborators

  • Augusta University

    collaborator OTHER

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • National Jewish Health

    lead OTHER

Principal Investigators

  • Jennifer Taylor-Cousar, MD, MSCS · National Jewish Health

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-05
Primary Completion
2024-06-30
Completion
2024-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04039087 on ClinicalTrials.gov