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Gala Early Feasibility Study of RheOx
NA trial testing RheOx in Chronic Bronchitis in 21 participants. Status unknown.
| Lead sponsor | Gala Therapeutics, Inc. |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 6 July 2018 |
| Primary completion | 30 January 2021 |
| Estimated completion | 30 December 2024 |
| Sites | 8 locations across United States |
Gala Therapeutics, Inc.
40 and older, any sex, with Chronic Bronchitis or Copd Bronchitis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Rate of serious adverse events of interest through 12 months. Events of interest are death, COPD exacerbation requiring hospitalization, pneumothrax within 2 days of procedure, pneumonia within 7 days of procedure, respiratory failure or arrhythmia requiring intervention.
| Group | Value | 95% CI |
|---|---|---|
| RheOx Treatment | 0 |
The change from baseline to 6 months in St. George's Respiratory Questionnaire (SGRQ) total score.
| Group | Value | 95% CI |
|---|---|---|
| RheOx Treatment | -13.3 | ± 11.7 |
The change from baseline to12 months in St. George's Respiratory Questionnaire (SGRQ) total score
| Group | Value | 95% CI |
|---|---|---|
| RheOx Treatment | -16.6 | ± 13.3 |
The change from baseline to 6 months in COPD Assessment Test (CAT) total score
| Group | Value | 95% CI |
|---|---|---|
| RheOx Treatment | -7.6 | ± 5.1 |
The change from baseline to 12 months in COPD Assessment Test (CAT) total score
| Group | Value | 95% CI |
|---|---|---|
| RheOx Treatment | -9.0 | ± 6.3 |
Time frame: 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | RheOx Treatment |
|---|---|---|
| pneumonia | Respiratory, thoracic and mediastinal disorders | — |
| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | — |
| hyponatremia | Blood and lymphatic system disorders | — |
| stress cardiomyopathy | Cardiac disorders | — |
| hip fracture | Musculoskeletal and connective tissue disorders | — |
| Reaction | System | RheOx Treatment |
|---|---|---|
| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | — |
| cough | Respiratory, thoracic and mediastinal disorders | — |
| sore throat | Respiratory, thoracic and mediastinal disorders | — |
| wheezing | Respiratory, thoracic and mediastinal disorders | — |
| headache | Nervous system disorders | — |
| lung nodule | Respiratory, thoracic and mediastinal disorders | — |
| Chest pain | General disorders | — |
| hemoptysis | Respiratory, thoracic and mediastinal disorders | — |
| Gastroenteritis | Infections and infestations | — |
| abnormal finding on CT scan | Investigations | — |
| urinary retention | Renal and urinary disorders | — |
Most-reported serious reactions: pneumonia, COPD exacerbation, hyponatremia, stress cardiomyopathy, hip fracture.
Data from ClinicalTrials.gov NCT03631472 adverse events section.
An early feasibility study (EFS) to assess the safety and clinical utility of RheOx on patients with chronic bronchitis in the United States.
5 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing