A Phase 1 interventional study of Inhaled SNSP113 and Inhaled Placebo in Lung Diseases, Pulmonary Disease and Cystic Fibrosis, sponsored by Synspira, Inc.. Terminated at 2 sites in United Kingdom. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-25.
Sponsored by Synspira, Inc. · Phase 1, Interventional, and Treatment
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Among 235 studies in Cystic Fibrosis with a site in United Kingdom — 20 open to participants now, 31 under way, 4 of them phase 3. Cystic Fibrosis · United Kingdom.
Among the 235 studies in Cystic Fibrosis with a site in United Kingdom, this one is the 124th largest by enrollment of the 186 interventional ones that give a count, is one of 21 that started in 2017, is one of 25 in phase 1, and was the 129th registered.
1,621 studies on the registry are indexed under Cystic Fibrosis; 201 are open to participants now.
Browse Cystic Fibrosis studies →20 of the 235 studies in Cystic Fibrosis with a site in United Kingdom are open now. Recruiting first, the newest first:
Aimmune Nestlé Health Science US R&D, LLC · Sites in United Kingdom, United States, Bulgaria and 4 more countries
Ages 18–85
University of Nottingham · Sites in United Kingdom
Ages 18–65 · Healthy volunteers
Alexander Horsley · Sites in United Kingdom
Ages 16+
Papworth Hospital NHS Foundation Trust · Sites in United Kingdom
Ages 18+
Royal Brompton & Harefield NHS Foundation Trust · Sites in United Kingdom
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 156 Cystic Fibrosis studies recruiting now, 95 (61%) set no upper age limit and 45 (29%) stop at 75 or younger; 86 take children under 18; 41 take healthy volunteers.
This study: 18 Years to 50 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
235 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 38 · Phase 2 53 · Phase 3 62 · Phase 4 9
First in 2001; this study’s year is marked. 21 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 32 is below the median of 36 across 1,053 interventional studies indexed under Cystic Fibrosis.
Median enrollment 69 across the 186 interventional studies, 77 across the 48 observational. Of the 186 that completed or were terminated, 83 (45%) have results posted.
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124 of 235 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Synspira, Inc. as lead sponsor.
Synspira, Inc. has 1 study filed under Cystic Fibrosis — fewer than ten, so there is no comparison to draw.
6 of the studies in Cystic Fibrosis with a site in United Kingdom that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06460506Phase 3Vertex Pharmaceuticals IncorporatedEvaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older | 2027-09-30 |
| NCT06237335ReCode TherapeuticsA Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CF | 2026-11 |
| NCT07780344University of NottinghamMRI Parameters as Biomarkers in Cystic Fibrosis (FEMPTO) | 2027-05 |
| NCT07879651Royal Brompton & Harefield NHS Foundation TrustSPutum Induction and Nebuliser deviCEs for Patients With CF | 2027-06 |
| NCT07559175Aimmune Nestlé Health Science US R&D, LLCA Study to Evaluate Safety and Explore Efficacy of New Lipase NHS7108 in Adult Participants With Exocrine Pancreatic Insufficiency. | 2027-06 |
Add all 6 to your calendar (.ics) → With an account.
Among the 235 studies in Cystic Fibrosis with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Although Cystic Fibrosis is a complex genetic disease affecting many organs, lung disease is the primary cause of mortality. The objective of this study is to determine the safety and tolerability of SNSP113 in healthy subjects and subjects with stable cystic fibrosis.
1,621 studies on the registry are indexed under Cystic Fibrosis; 201 are open to participants now.
This study's enrollment of 32 is below the median of 36 across 1,053 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →This is the only study on the registry with Synspira, Inc. as lead sponsor.
Compared within Cystic Fibrosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lung Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Part A
Part B
Exclusion Criteria:
Part A
Part B
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Inhaled SNSP113
Drug: Inhaled Placebo
A single ascending dose of inhaled SNSP113 will be administered to healthy subjects and subjects with stable cystic fibrosis.
A single dose of inhaled placebo control will be administered to healthy subjects and subjects with stable cystic fibrosis.
Incidence of adverse events
To determine the incidence of treatment related adverse events.
Time frame: 8 days
Spirometry
To assess change from baseline spirometry.
Time frame: 8 days
Pulse Oximetry
To assess change in baseline pulse oximetry
Time frame: 8 days
Observed maximum plasma concentration, taken directly from the individual concentration-time curve (Cmax)
To characterize the pharmacokinetics of SNSP113
Time frame: Days 1, 2 and 8
Area under concentration-time curve from time zero extrapolated to infinity (AUC)
To characterize the pharmacokinetics of SNSP113
Time frame: Days 1, 2 and 8
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2017 to primary completion in Dec 2017, 2 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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