Cystic FibrosisPhase 2(HOPE-1)NCT03229252
An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
A Phase 2 study testing SPX-101 in people with Cystic Fibrosis, run by Spyryx Biosciences, Inc. at 25 sites in 5 countries.
Trial summary
28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- SPX-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 25 sitesin 5 countries
- Study dates
- 1 Aug 2017to 20 Jun 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Significant unstable co-morbidities within 28 days of screening
- Has received an investigational drug within 28 days of screening
Trial locations and contacts
25 sites in 5 countries.
25 sites in 5 countries
United Kingdom13 sites
Belfast Health and Social Care Trust
Belfast
Heart of England NHS Foundation Trust
Birmingham
University Hospitals Bristol NHS Foundation Trust
Bristol
Western General Hospital - NHS Lothian
Edinburgh
Royal Devon and Exeter NHS Foundation Trust
Exeter
NHS Greater Glasgow and Clyde
Glasgow
The Leeds Teaching Hospitals NHS Trust
Leeds
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool
Barts Health NHS Trust Saint Bartholomews Hospital
London
Royal Brompton and Harefield NHS Foundation Trust
London
University Hospital of South Manchester NHS Foundation Trust
Manchester
Newcastle Upon Tyne Hospitals
Newcastle upon Tyne
Nottingham University Hospitals NHS Trust
Nottingham
France7 sites
CHU de Angers
Angers, Pays de la Loire Region
CHU de Montpellier
Montpellier, Languedoc-Roussillon
Hopital Pasteur
Nice, Provence-Alpes-Côte d'Azur Region
Assistance Publique-Hôpitaux de Paris Hôpital Cochin
Paris
Hospices Civils de Lyon (HCL)
Pierre-Bénite, Auvergne-Rhône-Alpes
Centre Hospitalier Universitaire Brest
Roscoff, Brittany Region
CHU de Rouen
Rouen, Haute-Normandie
Canada3 sites
University of Calgary Heritage Medical Research Center
Calgary, Alberta, T2N 1N4
Ottawa Hospital Research Institute/Institut de Recherche de l'Hospital d'Ottawa
Ottawa, Ontario, K1H 8L6
Saint Michael's Hospital
Toronto, Ontario, M5B1W8
About this study
Official 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)
28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
- Conditions
- Cystic Fibrosis
- Being tested
- Placebo Inhalation Solution, SPX-101
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Inhalation SolutionDrug
Normal Saline Inhalation Solution
SPX-101Drug
SPX-101 Inhalation Solution
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Inhalation solution twice daily for 28 days. Receives: Drug: Placebo Inhalation Solution |
| SPX-101 Low Dose | Experimental | Inhalation solution twice daily for 28 days. Receives: Drug: SPX-101 |
| SPX-101 High Dose | Experimental | Inhalation solution twice daily for 28 days. Receives: Drug: SPX-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percent Predicted FEV1
Measured: Baseline and Day 28
Secondary outcomes (2)
Number of Participants With Adverse Events
Measured: Day 1 through Day 28
Change From Baseline Through Day 28 in Clinical Laboratory Tests
Chemistry, Hematology, Urinalysis
Measured: Day 1 through Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start1 Aug 2017
- Primary completion20 Jun 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spyryx Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229252
- Sponsor's protocol ID
- SPX-101-CF-201
- Acronym
- (HOPE-1)
- Status last verified
- Dec 2019
- First submitted
- 14 Jul 2017
- Last updated
- 30 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT03229252
- Acronym / sponsor ID
- (HOPE-1) / SPX-101-CF-201
- Conditions
- Cystic Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Spyryx Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 25 Jul 2017 (actual)
- Results
- Posted 30 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo Inhalation SolutionPlacebo Inhalation solution twice daily for 28 days. |
| SPX-101 Low Dose | Experimental | Drug: SPX-101Inhalation solution twice daily for 28 days. |
| SPX-101 High Dose | Experimental | Drug: SPX-101Inhalation solution twice daily for 28 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Significant unstable co-morbidities within 28 days of screening
- Has received an investigational drug within 28 days of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo Inhalation SolutionNormal Saline Inhalation Solution | Drug | Placebo |
| SPX-101SPX-101 Inhalation Solution | Drug | SPX-101 High Dose, SPX-101 Low Dose |
Primary outcome
Change in Percent Predicted FEV1
Time frame: Baseline and Day 28
2 secondary outcomes
Number of Participants With Adverse Events
Time frame: Day 1 through Day 28
Change From Baseline Through Day 28 in Clinical Laboratory Tests
Time frame: Day 1 through Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cystic Fibrosis
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Phase 2 Study to Assess the Safety and Efficacy of ANG003
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
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Diagnostic Value of Oropharyngeal Suction and Effect of Respiratory Physiotherapy on the Detection of Microorganisms in the Pediatric Patient
Cystic Fibrosis (CF), Bronchiectasis, Non-Cystic Fibrosis
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Vascular Health and Function in Cystic Fibrosis
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Natural History of Noncirrhotic Portal Hypertension
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPX-101 in people with Cystic Fibrosis, run by Spyryx Biosciences, Inc. at 25 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United Kingdom, France, Canada, Italy, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percent Predicted FEV1 (time frame: Baseline and Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2019.