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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

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Clinical Trials for Budesonide; Formoterol Fumarate Dihydrate

Trial ID Title Status Sponsor Phase Summary
NCT00569712 Studying Genes in Blood and Lung Fluid Samples From Patients With Chronic Obstructive Pulmonary Disease With or Without a Previous Diagnosis of Lung Cancer or With Asthma Treated With Budesonide and Formoterol Completed Astra Zeneca Canada Phase 1 RATIONALE: Studying the genes expressed in samples of blood and lung fluid in the laboratory from patients receiving budesonide and formoterol may help doctors learn more about the effect of budesonide and formoterol on gene expression and biomarkers. PURPOSE: This clinical trial is studying genes in blood and lung fluid samples from patients with chronic obstructive pulmonary disease, with or without a previous diagnosis of lung cancer, or with asthma treated with budesonide and formoterol.
NCT00569712 Studying Genes in Blood and Lung Fluid Samples From Patients With Chronic Obstructive Pulmonary Disease With or Without a Previous Diagnosis of Lung Cancer or With Asthma Treated With Budesonide and Formoterol Completed British Columbia Cancer Agency Phase 1 RATIONALE: Studying the genes expressed in samples of blood and lung fluid in the laboratory from patients receiving budesonide and formoterol may help doctors learn more about the effect of budesonide and formoterol on gene expression and biomarkers. PURPOSE: This clinical trial is studying genes in blood and lung fluid samples from patients with chronic obstructive pulmonary disease, with or without a previous diagnosis of lung cancer, or with asthma treated with budesonide and formoterol.
NCT00964535 Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics Completed Orion Corporation, Orion Pharma Phase 1/Phase 2 The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbohaler in terms of the drug absorbed into the bloodstream.
NCT01386996 Comparison of Budesonide and Formoterol Absorption From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Completed Orion Corporation, Orion Pharma Phase 1 The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.
NCT01593826 Comparison of Absorption of Budesonide and Formoterol From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Completed Orion Corporation, Orion Pharma Phase 1 The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.
NCT01712854 Effects of Symbicort on the Ventilatory Kinematics Terminated AstraZeneca Phase 4 The purpose of this study is to investigate how budesonide/formoterol fumarate dihydrate (Symbicort ©) affects dynamic hyperinflation in patients with obstructive disease using Optoelectronic Plethysmography (OEP). This study is unique as it will be the first randomized, doubleblind, crossover study with a placebo inhaler and budesonide/formoterol fumarate dihydrate as the intervention which will evaluate the effects on ventilatory mechanics through the use of OEP. The investigators plan to demonstrate that budesonide/formoterol fumarate dihydrate impacts dynamic hyperinflation which can be detected with OEP, and that budesonide/formoterol fumarate dihydrate may have an effect in the short term on exercise capacity during a constant load exercise test. The changes in ventilatory mechanics measured after budesonide/formoterol fumarate dihydrate by OEP will provide a unique evaluation of budesonide/formoterol fumarate dihydrate in a controlled setting also demonstrating the utility of OEP in evaluating of the effects of a medical treatment on hyperinflation in individuals with chronic obstructive lung disease (COPD). 1. Primary Objective/Hypothesis: Our objective is to measure baseline, post treatment and post exercise spirometry and evaluate exercise dynamic hyperinflation before and after treatment using OEP. The investigators hypothesize that budesonide/formoterol fumarate dihydrate will decrease dynamic hyperinflation as measured by OEP. 2. Primary Endpoint: Our primary endpoint is the change in dynamic hyperinflation, specifically end expiratory volumes, dynamic lung volumes and diaphragmatic paradoxical breathing as measured by OEP. 3. Secondary Objective: Our secondary objective is to evaluate duration of steady state exercise and exercise capacity before and after treatment. Our secondary hypothesis is that decreases in dynamic hyperinflation during exercise will lead to improvements in dyspnea with exercise, and allow for increases in exercise capacity. 4. Secondary endpoint: Exercise time, change in Borg scale at rest vs. Borg scale at steady state vs. Borg at end exercise.
NCT01712854 Effects of Symbicort on the Ventilatory Kinematics Terminated Columbia University Phase 4 The purpose of this study is to investigate how budesonide/formoterol fumarate dihydrate (Symbicort ©) affects dynamic hyperinflation in patients with obstructive disease using Optoelectronic Plethysmography (OEP). This study is unique as it will be the first randomized, doubleblind, crossover study with a placebo inhaler and budesonide/formoterol fumarate dihydrate as the intervention which will evaluate the effects on ventilatory mechanics through the use of OEP. The investigators plan to demonstrate that budesonide/formoterol fumarate dihydrate impacts dynamic hyperinflation which can be detected with OEP, and that budesonide/formoterol fumarate dihydrate may have an effect in the short term on exercise capacity during a constant load exercise test. The changes in ventilatory mechanics measured after budesonide/formoterol fumarate dihydrate by OEP will provide a unique evaluation of budesonide/formoterol fumarate dihydrate in a controlled setting also demonstrating the utility of OEP in evaluating of the effects of a medical treatment on hyperinflation in individuals with chronic obstructive lung disease (COPD). 1. Primary Objective/Hypothesis: Our objective is to measure baseline, post treatment and post exercise spirometry and evaluate exercise dynamic hyperinflation before and after treatment using OEP. The investigators hypothesize that budesonide/formoterol fumarate dihydrate will decrease dynamic hyperinflation as measured by OEP. 2. Primary Endpoint: Our primary endpoint is the change in dynamic hyperinflation, specifically end expiratory volumes, dynamic lung volumes and diaphragmatic paradoxical breathing as measured by OEP. 3. Secondary Objective: Our secondary objective is to evaluate duration of steady state exercise and exercise capacity before and after treatment. Our secondary hypothesis is that decreases in dynamic hyperinflation during exercise will lead to improvements in dyspnea with exercise, and allow for increases in exercise capacity. 4. Secondary endpoint: Exercise time, change in Borg scale at rest vs. Borg scale at steady state vs. Borg at end exercise.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Budesonide; Formoterol Fumarate Dihydrate

Condition Name

Condition Name for Budesonide; Formoterol Fumarate Dihydrate
Intervention Trials
Asthma 7
Bioequivalence 1
Precancerous Condition 1
Lung Cancer 1
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Condition MeSH

Condition MeSH for Budesonide; Formoterol Fumarate Dihydrate
Intervention Trials
Pulmonary Disease, Chronic Obstructive 3
Asthma 2
Lung Diseases, Obstructive 2
Lung Diseases 2
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Clinical Trial Locations for Budesonide; Formoterol Fumarate Dihydrate

Trials by Country

Trials by Country for Budesonide; Formoterol Fumarate Dihydrate
Location Trials
United States 24
Finland 3
United Kingdom 2
Austria 1
Sweden 1
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Trials by US State

Trials by US State for Budesonide; Formoterol Fumarate Dihydrate
Location Trials
Washington 1
Minnesota 1
Arkansas 1
California 1
Colorado 1
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Clinical Trial Progress for Budesonide; Formoterol Fumarate Dihydrate

Clinical Trial Phase

Clinical Trial Phase for Budesonide; Formoterol Fumarate Dihydrate
Clinical Trial Phase Trials
Phase 4 1
Phase 3 3
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Budesonide; Formoterol Fumarate Dihydrate
Clinical Trial Phase Trials
Completed 6
Recruiting 1
Terminated 1
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Clinical Trial Sponsors for Budesonide; Formoterol Fumarate Dihydrate

Sponsor Name

Sponsor Name for Budesonide; Formoterol Fumarate Dihydrate
Sponsor Trials
Orion Corporation, Orion Pharma 3
Columbia University 1
AstraZeneca 1
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Sponsor Type

Sponsor Type for Budesonide; Formoterol Fumarate Dihydrate
Sponsor Trials
Industry 8
Other 3
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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
US Department of Justice
Cipla
Fuji
McKinsey
Harvard Business School
AstraZeneca
Chinese Patent Office
Federal Trade Commission

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