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Last Updated: July 5, 2020

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CLINICAL TRIALS PROFILE FOR BECLOMETHASONE DIPROPIONATE

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505(b)(2) Clinical Trials for Beclomethasone Dipropionate

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 NCT00497237 Clinical Trial of the Efficacy and Safety of Beclomethasone Dipropionate Plus Formoterol vs Fluticasone Propionate Plus Salmeterol in the 6 Months Step Down Treatment of Asthma Completed Chiesi Farmaceutici S.p.A. Phase 3 2007-04-01 Asthma is a serious global health problem. People of all ages in countries throughout the world are affected by this chronic airway disorder that can be severe and sometimes fatal. The prevalence of asthma is increasing everywhere, especially among children.According to international guidelines, once control of asthma is achieved and maintained for at least 3 months, a gradual reduction of the maintenance therapy should be tried in order to identify the minimum therapy required to maintain control. This will help reduce the risk of side effects and enhance patient adherence to the treatment plan. Reduction of therapy in patients on combination therapy should begin with a reduction in the dose of inhaled glucocorticosteroid.1 The present study is designed to evaluate if patients with controlled asthma treated with FP 1000 mcg + salmeterol 100 mcg daily can be stepped down. Stepping-down will be attempted with two medications: a new combination of extrafine beclomethasone dipropionate 400 mcg + formoterol 24 mcg daily (test medication, Foster™) and, alternatively, fluticasone propionate 500 mcg + salmeterol 100 mcg daily(reference medication) without losing asthma control.If this hypothesis will be confirmed, the present study will demonstrate that asthma control can be maintained with less than half the dose of inhaled corticosteroid and with less medical costs. Given the aims of this study, the population to be monitored includes adult patients with moderate persistent asthma, which can be defined controlled according to the current guidelines under standard stabilised treatment. The intended treatment duration is therefore designed to ensure that good control of asthma is firmly achieved before stepping down the treatment (8 weeks run-in period), but also that the condition of the patients are followed long enough (24 weeks comparative treatment period) to ensure that a new stable condition is also obtained and properly monitored.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Beclomethasone Dipropionate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000577 Asthma Clinical Research Network (ACRN) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1993-09-01 This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma.
NCT00000752 Preventing Frequent Sinus Infections in HIV-Infected Patients Withdrawn Adams Laboratories Phase 2 1969-12-31 To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant ( Deconsal II ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent paranasal sinus infection. To determine relevant prognostic factors and the microbiologic etiology of maxillary sinusitis in this patient population. Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted.
NCT00000752 Preventing Frequent Sinus Infections in HIV-Infected Patients Withdrawn Glaxo Wellcome Phase 2 1969-12-31 To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant ( Deconsal II ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent paranasal sinus infection. To determine relevant prognostic factors and the microbiologic etiology of maxillary sinusitis in this patient population. Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted.
NCT00000752 Preventing Frequent Sinus Infections in HIV-Infected Patients Withdrawn National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant ( Deconsal II ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent paranasal sinus infection. To determine relevant prognostic factors and the microbiologic etiology of maxillary sinusitis in this patient population. Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted.
NCT00010283 Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon Completed National Cancer Institute (NCI) Phase 1/Phase 2 2000-07-01 RATIONALE: Beclomethasone may be an effective treatment for graft-versus-host disease. PURPOSE: Phase I/II trial to study the effectiveness of beclomethasone in treating patients who have graft-versus-host disease of the esophagus, stomach, small intestine, or colon.
NCT00010283 Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon Completed Fred Hutchinson Cancer Research Center Phase 1/Phase 2 2000-07-01 RATIONALE: Beclomethasone may be an effective treatment for graft-versus-host disease. PURPOSE: Phase I/II trial to study the effectiveness of beclomethasone in treating patients who have graft-versus-host disease of the esophagus, stomach, small intestine, or colon.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Beclomethasone Dipropionate

Condition Name

Condition Name for Beclomethasone Dipropionate
Intervention Trials
Asthma 37
Chronic Obstructive Pulmonary Disease 6
Bronchial Asthma 5
COPD 4
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Condition MeSH

Condition MeSH for Beclomethasone Dipropionate
Intervention Trials
Asthma 31
Rhinitis 12
Pulmonary Disease, Chronic Obstructive 12
Rhinitis, Allergic 12
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Clinical Trial Locations for Beclomethasone Dipropionate

Trials by Country

Trials by Country for Beclomethasone Dipropionate
Location Trials
United States 278
Italy 13
United Kingdom 11
Poland 10
Ukraine 7
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Trials by US State

Trials by US State for Beclomethasone Dipropionate
Location Trials
California 16
Texas 15
New York 13
Washington 12
Pennsylvania 12
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Clinical Trial Progress for Beclomethasone Dipropionate

Clinical Trial Phase

Clinical Trial Phase for Beclomethasone Dipropionate
Clinical Trial Phase Trials
Phase 4 7
Phase 3 49
Phase 2 18
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Clinical Trial Status

Clinical Trial Status for Beclomethasone Dipropionate
Clinical Trial Phase Trials
Completed 64
Recruiting 6
Terminated 6
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Clinical Trial Sponsors for Beclomethasone Dipropionate

Sponsor Name

Sponsor Name for Beclomethasone Dipropionate
Sponsor Trials
Chiesi Farmaceutici S.p.A. 40
Teva Branded Pharmaceutical Products, R&D Inc. 10
Teva Pharmaceutical Industries 6
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Sponsor Type

Sponsor Type for Beclomethasone Dipropionate
Sponsor Trials
Industry 75
Other 25
NIH 7
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