At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 91 enrolled
Drug / intervention
Placebo Inhalation Solution +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Placebo Inhalation Solution and SPX-101 for Cystic Fibrosis. Completed, enrolled 91 participants across 25 sites in 5 countries.
Detailed Summary
28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesCanada, France, Italy, Portugal, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 2017
Enrollment StartAug 2017
Primary CompletionJun 2019
TodayJul 2026
First PostedJul 25, 2017
Enrollment StartAug 1, 2017
Primary CompletionJun 20, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.9 years ago
Interventions
Placebo Inhalation Solutiondrug
Normal Saline Inhalation Solution
SPX-101drug
SPX-101 Inhalation Solution