A Study in Adult and Pediatric Patients With Cystic Fibrosis

The purpose of this ascending dose group study is to assess the safety, tolerability, and effects of multiple dose levels of INS37217 and placebo followed by five days twice daily treatment with maximum tolerated dose administered by inhalation via the Pari LC Star nebulizer in adult and pediatric patients with cystic fibrosis

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

FEV1 40-70% (adults)
FEV1 >/=50% (pediatrics)
oxygen saturation >90%
clinically stable
willing to stay overnight

Exclusion criteria

abnormal renal or liver function
receiving corticosteroids exceeding 10mg/day or 20 mg every other day
received intravenous or aerosolized antibiotics 1 week prior to dosing

Treatment and study plan

Denufosol Tetrasodium (INS37217) Inhalation Solution

Drug

Primary outcomes

assess safety and tolerability

Secondary outcomes

assess effects of INS37217 on sputum weight and symptoms

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Ph 1b/2a Study to Assess Levels of INS37217 and Placebo Treatment With Maximum Tolerated Dose Administered by Inhalation Via the Pari LC Star Nebulizer in Adult and Pediatric CF Patients

Important dates

Study start: 2001
Primary completion: 2002
Study completion: 2002
First posted: Apr 30, 2002
Registry last updated: Feb 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed