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Completed

NCT Number: NCT03229252

An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis

28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects 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

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Calgary Heritage Medical Research Center, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed diagnosis of cystic fibrosis
  • ppFEV1 (percent predicted FEV1) between 50.0% and 80.0%
  • Stable CF Lung Disease
  • Males and non-pregnant, non-lactating females

Exclusion criteria

  • Significant unstable co-morbidities within 28 days of screening
  • Has received an investigational drug within 28 days of screening

Treatment and study plan

Placebo Inhalation Solution

Drug

Normal Saline Inhalation Solution

SPX-101

Drug

SPX-101 Inhalation Solution

Primary outcomes

  1. Change in Percent Predicted FEV1

    Time frame: Baseline and Day 28

Secondary outcomes

  1. Number of Participants With Adverse Events

    Time frame: Day 1 through Day 28

  2. Change From Baseline Through Day 28 in Clinical Laboratory Tests

    Time frame: Day 1 through Day 28

    Chemistry, Hematology, Urinalysis

Sponsors and collaborators

Lead sponsor

Spyryx Biosciences, Inc.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis (HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness)

Acronym: (HOPE-1)

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 25, 2017
Registry last updated
Dec 30, 2019

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.

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