Research Study Summary
Join our clinical research study for asthmatics who have experienced a serious asthma episode in the past year
We are seeking study volunteers at least 12 years of age who have required treatment with systemic corticosteroids (tablets, suspension or injection) OR who have been hospitalized for 24 hours or more due to a worsening of asthma within the past year.
This clinical study is being undertaken with the purpose of comparing the incidence of serious asthma outcomes in study participants treated during the study primarily with a combination of inhaled steroid and a long-acting beta-agonist (bronchodilator*) medication and those treated primarily with an inhaled steroid medication alone. A serious asthma outcome includes asthma-related hospitalization, intubation (the insertion of a breathing tube), and death.
* A medication that relaxes the involuntary muscles of the airways in the body. When these muscles are tightened, they constrict airflow; when relaxed, they allow the air to move more freely through the airways.
- Study duration: There will be 5 visits to the research office during the study and 4 required telephone contacts between visits. Those who qualify at the end of the screening period, which may last up to 14 days, will receive investigational study medication in a double-blinded manner (neither the study volunteer nor the staff at the research site will know which treatment has been assigned). The treatment period of the study will last 26 weeks.
- Study drug: The investigational study medications include a combination of two types of asthma medications: a inhaled steroid and a long-acting bronchodilator; also included is a medication consisting of a inhaled steroid alone. These investigational study medications will be delivered by means of a metered dose inhaler in fixed doses. Rescue medication will also be provided (a short-acting bronchodilator) for use as needed throughout the study.
- Study Procedures: Procedures for the study include physical exams and a 12-lead electrocardiogram (ECG). Study participants will use an electronic diary system to record information between visits.
- There is no charge for participation. Study medication, study procedures and study visits are provided at no cost.
- Compensation will be provided to qualified participants to help cover study-related time and/or travel.
- Principal Investigator: Jeffrey Rumbyrt, M.D. of Denver Allergy & Asthma Associates
Patient Inclusion Criteria:
KEY INCLUSION CRITERIA:
- Males or females at least 12 years old.
- Diagnosed with asthma for at least one year.
- Currently using one of the following asthma treatments:
- An inhaled corticosteroid alone or with one or more additional therapies (a long-acting bronchodilator; a leukotriene receptor antagonist, such as Singulair® or Accolate®; or theophylline) at a stable dose for at least 4 weeks
- A leukotriene receptor antagonist, such as Singulair® or Accolate®, or a xanthine, such as theophylline, at a stable dose for at least 4 weeks
- Albuterol/salbutamol used on most days without any other asthma controller for at least 4 weeks, but not more than 8 inhalations per day on 2 consecutive days or = 25 inhalations in one day during the past 7 days.
- Experienced at least one asthma exacerbation between the past 4 to 52 weeks. An asthma exacerbation is considered a worsening of asthma to include at least one of the following: use of systemic corticosteroids (tablets, suspension or injection) OR an in-patient hospitalization defined as a hospital stay of at least 24 hours.
- Females of childbearing potential must be willing to undergo a urine pregnancy test, which must have a negative result, at the Screening Visit (Visit 1) and at the Baseline Visit (Visit 2).
- Willing and able to fulfill the study requirements for taking prescribed doses of study medication regularly and keeping study appointments during the approximately 6 month period of study participation.
Patient Exclusion Criteria:
KEY EXCLUSION CRITERIA:
- Experienced more than 4 separate asthma exacerbations (as defined above) within the past 52 weeks (each exacerbation must be separated by more than 7 days to be considered a separate event).
- Experienced more than 2 separate hospitalizations (as defined above) within the past 52 weeks (each hospitalization must be separated by more than 7 days to be considered a separate event).
- Smoking history equivalent to 1 pack of cigarettes a day for 10 years (10 pack-years).
- Diagnosed with COPD, cystic fibrosis or any other significant, non-asthmatic lung disease.
Please contact our clinical research site for further information about this study! Parents should call for minors that are interested in more information.
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Date Last Changed:
August 1, 2014