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28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo Inhalation solution twice daily for 28 days. |
|
| SPX-101 Low Dose | Experimental | Inhalation solution twice daily for 28 days. |
|
| SPX-101 High Dose | Experimental | Inhalation solution twice daily for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Inhalation Solution | Drug | Normal Saline Inhalation Solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent Predicted FEV1 | Baseline and Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Day 1 through Day 28 | |
| Change From Baseline Through Day 28 in Clinical Laboratory Tests | Chemistry, Hematology, Urinalysis | Day 1 through Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary Heritage Medical Research Center | Calgary | Alberta | T2N 1N4 | Canada | ||
| Ottawa Hospital Research Institute/Institut de Recherche de l'Hospital d'Ottawa |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo Inhalation solution twice daily for 28 days. Placebo Inhalation Solution: Normal Saline Inhalation Solution |
| FG001 | SPX-101 Low Dose (60mg BID) | Inhalation solution twice daily for 28 days. SPX-101: SPX-101 Inhalation Solution |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 14, 2018 | Aug 26, 2019 |
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Double-Blind
| SPX-101 |
| Drug |
SPX-101 Inhalation Solution |
|
| Ottawa |
| Ontario |
| K1H 8L6 |
| Canada |
| Saint Michael's Hospital | Toronto | Ontario | M5B1W8 | Canada |
| Hospices Civils de Lyon (HCL) | Pierre-Bénite | Auvergne-Rhône-Alpes | France |
| Centre Hospitalier Universitaire Brest | Roscoff | Brittany Region | France |
| CHU de Rouen | Rouen | Haute-Normandie | France |
| CHU de Montpellier | Montpellier | Languedoc-Roussillon | France |
| CHU de Angers | Angers | Pays de la Loire Region | France |
| Hopital Pasteur | Nice | Provence-Alpes-Côte d'Azur Region | France |
| Assistance Publique-Hôpitaux de Paris Hôpital Cochin | Paris | France |
| Istituto Giannina Gaslini Ospedale Pediatrico | Genoa | Italy |
| Hospital de Santa Maria | Lisbon | Portugal |
| Belfast Health and Social Care Trust | Belfast | United Kingdom |
| Heart of England NHS Foundation Trust | Birmingham | United Kingdom |
| University Hospitals Bristol NHS Foundation Trust | Bristol | United Kingdom |
| Western General Hospital - NHS Lothian | Edinburgh | United Kingdom |
| Royal Devon and Exeter NHS Foundation Trust | Exeter | United Kingdom |
| NHS Greater Glasgow and Clyde | Glasgow | United Kingdom |
| The Leeds Teaching Hospitals NHS Trust | Leeds | United Kingdom |
| Liverpool Heart and Chest Hospital NHS Foundation Trust | Liverpool | United Kingdom |
| Barts Health NHS Trust Saint Bartholomews Hospital | London | United Kingdom |
| Royal Brompton and Harefield NHS Foundation Trust | London | United Kingdom |
| University Hospital of South Manchester NHS Foundation Trust | Manchester | United Kingdom |
| Newcastle Upon Tyne Hospitals | Newcastle upon Tyne | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | United Kingdom |
| FG002 | SPX-101 High Dose (120mg BID) | Inhalation solution twice daily for 28 days. SPX-101: SPX-101 Inhalation Solution |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo Inhalation solution twice daily for 28 days. Placebo Inhalation Solution: Normal Saline Inhalation Solution |
| BG001 | SPX-101 Low Dose (60mg BID) | Inhalation solution twice daily for 28 days. SPX-101: SPX-101 Inhalation Solution |
| BG002 | SPX-101 High Dose (120mg BID) | Inhalation solution twice daily for 28 days. SPX-101: SPX-101 Inhalation Solution |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Percent Predicted FEV1 | Posted | Mean | Standard Deviation | change from baseline in ppFEV1 | Baseline and Day 28 |
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| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | Posted | Count of Participants | Participants | Day 1 through Day 28 |
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| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline Through Day 28 in Clinical Laboratory Tests | Chemistry, Hematology, Urinalysis | Posted | Count of Participants | Participants | Day 1 through Day 28 |
|
|
28 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo Inhalation solution twice daily for 28 days. Placebo Inhalation Solution: Normal Saline Inhalation Solution | 0 | 31 | 1 | 31 | 20 | 31 |
| EG001 | SPX-101 Low Dose (60mg BID) | Inhalation solution twice daily for 28 days. SPX-101: SPX-101 Inhalation Solution | 0 | 15 | 0 | 15 | 10 | 15 |
| EG002 | SPX-101 High Dose (120mg BID) | Inhalation solution twice daily for 28 days. SPX-101: SPX-101 Inhalation Solution | 0 | 45 | 3 | 45 | 29 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infective Pulmonary Exacerbation of Cystic Fibrosis | Infections and infestations | Systematic Assessment |
| ||
| Intestinal Obstuction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cough and Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sputum Increased | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Lower Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Increased Viscosity of Bronchial Secretion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sputum Discolored | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Infective Pulmonary Exacerbation of Cystic Fibrosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Frequent Bowel Movements | Gastrointestinal disorders | Systematic Assessment |
| ||
| Tongue Coated | Gastrointestinal disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Migraine | Nervous system disorders | Systematic Assessment |
| ||
| Chest Discomfort | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Forced Expiratory Volume Decreased | Investigations | Systematic Assessment |
| ||
| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
No Limitations or Caveats
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rob Tarran | Spyryx Biosciences | 919-966-7052 | rtarran@spyryxbio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 9, 2019 | Aug 26, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Italy |
|
| United Kingdom |
|
| France |
|
| Portugal |
|
|
|