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Last Updated: December 21, 2024

CLINICAL TRIALS PROFILE FOR KRYPTON, KR-81M


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505(b)(2) Clinical Trials for krypton, kr-81m

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT03906045 ↗ A Scintigraphy Study of PT010 in COPD Patients Completed Simbec Research Phase 1 2019-04-04 This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.
New Combination NCT03906045 ↗ A Scintigraphy Study of PT010 in COPD Patients Completed AstraZeneca Phase 1 2019-04-04 This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for krypton, kr-81m

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02005432 ↗ PASCAL Laser Versus ETDRS Laser Associated With Intravitreal Ranibizumab (IVR) Versus Only IVR for Proliferative Diabetic Retinopathy Unknown status University of Sao Paulo Phase 4 2012-02-01 Objectives: Primary objective: To evaluate the effects on retinal morphophysiology of full scatter single target panretinal photocoagulation (PRP) versus full scatter multiple target panretinal photocoagulation (both combined with intravitreous injections of ranibizumab) versus intravitreous ranibizumab (IVR) alone in patients with proliferative diabetic retinopathy (PDR). Primary outcome: The primary endpoint for this study is the mean change in the total area of active retinal neovessels, as measured by fluorescein angiography leakage area, in mm2, from baseline to week 48. Secondary objectives: - To assess the mean changes in best corrected visual acuity (BCVA), the mean changes in central subfield foveal thickness (CSFT), the mean changes in wave B amplitude and oscillatory potentials on a full-field electroretinogram (ERG), and the mean changes on the peripheral visual field by static perimetry (30:2 strategy), from baseline to week 48. - To assess the incidence of adverse events during the study. Strategic goal: In the era of anti-VEGF treatment for retinal neovascularization 1, 2, 3, 4 , it is time to determine what would be the best association of PRP + anti-VEGF for proliferative diabetic retinopathy (PDR), or still, if just intravitreal anti-VEGF treatment would be even better regarding morphologic (new vessels area and CSFT) and functional parameters (BCVA, ERG response and visual field).
NCT03906045 ↗ A Scintigraphy Study of PT010 in COPD Patients Completed Simbec Research Phase 1 2019-04-04 This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.
NCT03906045 ↗ A Scintigraphy Study of PT010 in COPD Patients Completed AstraZeneca Phase 1 2019-04-04 This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for krypton, kr-81m

Condition Name

Condition Name for krypton, kr-81m
Intervention Trials
Chronic Obstructive Pulmonary Disease 1
Proliferative Diabetic Retinopathy 1
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Condition MeSH

Condition MeSH for krypton, kr-81m
Intervention Trials
Lung Diseases, Obstructive 1
Lung Diseases 1
Retinal Diseases 1
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Clinical Trial Locations for krypton, kr-81m

Trials by Country

Trials by Country for krypton, kr-81m
Location Trials
United Kingdom 1
Brazil 1
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Clinical Trial Progress for krypton, kr-81m

Clinical Trial Phase

Clinical Trial Phase for krypton, kr-81m
Clinical Trial Phase Trials
Phase 4 1
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for krypton, kr-81m
Clinical Trial Phase Trials
Completed 1
Unknown status 1
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Clinical Trial Sponsors for krypton, kr-81m

Sponsor Name

Sponsor Name for krypton, kr-81m
Sponsor Trials
University of Sao Paulo 1
Simbec Research 1
AstraZeneca 1
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Sponsor Type

Sponsor Type for krypton, kr-81m
Sponsor Trials
Industry 2
Other 1
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