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Last Updated: April 8, 2020

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CLINICAL TRIALS PROFILE FOR DULERA

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All Clinical Trials for DULERA

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00576069 Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma Recruiting Gelb, Arthur F., M.D. Phase 4 2007-10-01 The purpose of this study is to evaluate the site and mechanisms responsible for expiratory airflow limitation in chronic, treated, non-smoking, stable asthmatics with moderate to severe persistent expiratory airflow obstruction. Treatment will include inhaled corticosteroids and long acting beta2agonists and long acting muscarinic antagonists. We are interested in determining whether the large and/or small airways are the predominant site of airflow limitation. We are also interested in determining whether intrinsic small airways obstruction and/or loss of lung elastic recoil is responsible for expiratory airflow limitation and to what extent may be attributed to loss of lung elastic recoil vs decreased airway conductance in peripheral airways. We are also interested to evaluate the role of varying doses of inhaled corticosteroids to suppress large and small airway inflammation using exhaled nitric oxide as surrogate markers of inflammation. For comparison purposes, spirometry and measurements of exhaled nitric oxide will also be obtained if possible during a naturally occurring exacerbation of asthma. High resolution thin section CT of the lung will also be obtained. Analysis will evaluate integrity of the lung parenchyma as to absence and or presence of emphysema and extent of emphysema using voxel quantification. We will also investigate optical coherence tomography to detect clinically unsuspected emphysema. We will also obtain autopsy material when available in asthmatics who expire
NCT01471340 A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241 AM3) Completed Merck Sharp & Dohme Corp. Phase 4 2012-01-01 The purpose of this study is to test the safety of DULERA. DULERA is a pressurized metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and formoterol in a single inhaler. Mometasone is an inhaled corticosteroid (ICS), which reduces the inflammation in the airways. Formoterol is a long-acting beta 2 agonist (LABA), which helps to relax the muscles of the airways in the lungs, making it easier to breathe. In combination, mometasone and formoterol are used for the treatment of asthma. This study will evaluate whether participants taking a LABA in combination with an ICS in a single inhaler have a different risk of having serious asthma events (hospitalization, intubation and death) compared to participants taking an ICS alone.
NCT02045875 Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence Unknown status Merck Sharp & Dohme Corp. Phase 4 2014-01-01 40 subjects with moderate-to-severe asthma will be randomly selected for study in which 20, will be monitored for medication use (Dulera 100/5, Dulera 200/5 and Proventil HFA) over 3 months. These intervention subjects will receive medication use feedback at each visit, while the control group will receive the standard of asthma care. Those interventional subjects with Dulera adherence<60% will receive feedback based on an asthma adherence disease management model protocol, Asthma Adherence Pathway. Intervention clinicians will been trained in Motivational Interviewing to reduce subject ambivalence about medication use. The primary hypothesis is that subjects who receive medication monitoring and Motivational Interviewing adherence strategies will have better asthma control, as measured by the Asthma Control Questionnaire, than the control group.
NCT02045875 Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence Unknown status West Penn Allegheny Health System Phase 4 2014-01-01 40 subjects with moderate-to-severe asthma will be randomly selected for study in which 20, will be monitored for medication use (Dulera 100/5, Dulera 200/5 and Proventil HFA) over 3 months. These intervention subjects will receive medication use feedback at each visit, while the control group will receive the standard of asthma care. Those interventional subjects with Dulera adherence<60% will receive feedback based on an asthma adherence disease management model protocol, Asthma Adherence Pathway. Intervention clinicians will been trained in Motivational Interviewing to reduce subject ambivalence about medication use. The primary hypothesis is that subjects who receive medication monitoring and Motivational Interviewing adherence strategies will have better asthma control, as measured by the Asthma Control Questionnaire, than the control group.
NCT02045875 Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence Unknown status Asthma Management Systems Phase 4 2014-01-01 40 subjects with moderate-to-severe asthma will be randomly selected for study in which 20, will be monitored for medication use (Dulera 100/5, Dulera 200/5 and Proventil HFA) over 3 months. These intervention subjects will receive medication use feedback at each visit, while the control group will receive the standard of asthma care. Those interventional subjects with Dulera adherence<60% will receive feedback based on an asthma adherence disease management model protocol, Asthma Adherence Pathway. Intervention clinicians will been trained in Motivational Interviewing to reduce subject ambivalence about medication use. The primary hypothesis is that subjects who receive medication monitoring and Motivational Interviewing adherence strategies will have better asthma control, as measured by the Asthma Control Questionnaire, than the control group.
NCT02573233 Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma Recruiting Regeneron Pharmaceuticals Phase 2 2016-01-01 Primary Objective: To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in patients with persistent asthma. Secondary Objective: To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.
NCT02573233 Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma Recruiting Sanofi Phase 2 2016-01-01 Primary Objective: To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in patients with persistent asthma. Secondary Objective: To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for DULERA

Condition Name

Condition Name for DULERA
Intervention Trials
Asthma 4
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Condition MeSH

Condition MeSH for DULERA
Intervention Trials
Asthma 4
Inflammation 1
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Clinical Trial Locations for DULERA

Trials by Country

Trials by Country for DULERA
Location Trials
United States 8
Germany 1
Canada 1
United Kingdom 1
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Trials by US State

Trials by US State for DULERA
Location Trials
Pennsylvania 2
North Carolina 1
Missouri 1
Massachusetts 1
Colorado 1
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Clinical Trial Progress for DULERA

Clinical Trial Phase

Clinical Trial Phase for DULERA
Clinical Trial Phase Trials
Phase 4 3
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for DULERA
Clinical Trial Phase Trials
Recruiting 2
Unknown status 1
Completed 1
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Clinical Trial Sponsors for DULERA

Sponsor Name

Sponsor Name for DULERA
Sponsor Trials
Merck Sharp & Dohme Corp. 2
Regeneron Pharmaceuticals 1
Asthma Management Systems 1
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Sponsor Type

Sponsor Type for DULERA
Sponsor Trials
Industry 5
Other 2
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