Birmingham, Alabama (PRWEB) November 19, 2013
*To see if you qualify for this Asthma Clinical Trial in Alabama, visit Achieve Clinical Research on the web (http://www.achieveclinical.com/) or contact us directly at (205) 380-6434. There is no cost to participate, no insurance is required, and you may receive compensation for time and travel.
This study is a randomized, parallel-group, multicenter study, 26 weeks in duration, that is designed to evaluate the non-inferiority of a new combination treatment versus an inhaled asthma medication on the composite endpoint of serious asthmatic outcomes (asthma-related hospitalization, endotracheal intubation, and death) in subjects. This study will be conducted at approximately 1100 centers in approximately 50 countries. Each site will recruit an estimated 10-12 subjects.
BACKGROUND & RATIONALE
Asthma is a chronic disease of the airways characterized by inflammation, bronchoconstriction, and airway hyper-responsiveness. The inhaled medication in this study, a type of corticosteroid, has been shown to be effective in the treatment of the inflammatory component of the disease, and the other asthma medication, a long acting beta2-agonist (LABA), has been shown to be effective in alleviating smooth muscle contraction.
A systematic review of prior clinical trials was conducted in 2008 to summarize the efficacy and risks of asthma control provided by combining these asthma treatments in adults and children. The results from this review demonstrated that treatment with this combination therapy resulted in greater benefit in lung function compared with either on it’s own plus other treatment. Similar results were seen for symptom-free days, rescue-free days and quality of life in adults and children. Concurrent use of these asthma drugs was also shown to significantly reduce exacerbations requiring treatment with systemic corticosteroids.
The primary objective of the study is to evaluate whether the combination therapy is non-inferior to the inhalation therapy alone in terms of the risk of serious asthma related events (asthma-related hospitalization, endotracheal intubation, and death). To declare non-inferiority the relative risk of serious events associated with this combination treatment compared with the inhalation medication alone must be less than 2.0 (a 2-fold increase), based on the upper bound of the 95% confidence interval on the estimate of relative risk.
As similar brand specific studies will be performed by the other manufacturers of these medications, that have an indication for asthma, a further objective is to study asthma-related mortality across the brand specific studies and to evaluate whether the concomitant use of this combination therapy increases asthma mortality compared with inhalation alone.
Each sponsor specific study is statistically powered on the same primary objective.
1. Informed Consent:
a. The subject and/or the subject’s legal guardian (if applicable) must provide written informed assent/consent to take part in the study.
b. Subjects and/or their legal guardians (if applicable) understand that they must comply with study treatment and study assessments including recording of daily information regarding their asthma status and attend scheduled study visits, and be accessible by telephone.
2. Subject: 12 years of age and older.
3. Gender: Male or female.
4. Asthma Diagnosis: Persistent asthma, defined by national and international asthma guidelines for at least 1 year prior to study enrolment. If the subject is naïve to the study site, the diagnosis of asthma must be confirmed by subject history.
5. PEF: A clinic PEF≥50% of predicted normal value. Percent predicted PEF values must be calculated using NHANES III with relevant equations that adjust for race and national origin.
6. Current Asthma Therapy: Subjects must be appropriately using one of the following for the treatment of asthma and meet the criteria outlined below:
a. The inhaled drug on it’s own or combined with one or more adjunctive therapies for at least 4 weeks prior to randomization. Any subject maintained on a stable high dose of this inhaled medication or stable high dose of the combination must have an ACQ-6 < 1.5 (i.e., controlled) at Visit 1.
b. A monotherapy at a stable dose for at least 4 weeks prior to randomization. Subjects on monotherapy are eligible only if they record an ACQ-6 score of ≥ 1.5 (i.e. not well controlled) and in the Investigator’s clinical judgement, the subject’s asthma severity could justify treatment with the inhalation treatment or combination treatment.
c. Daily rescue medication in the 4 weeks prior to randomization. Subjects on this medication are eligible only if they record an ACQ-6 score of ≥ 1.5 and in the investigator’s clinical judgement, the subject’s asthma severity could justify treatment with the inhalation treatment or combination treatment.
7. Exacerbation History: Subject must have a history of one of the following:
a. at least one asthma exacerbation requiring treatment with a systemic corticosteroid (tablets, suspension, or injection) between 30 days and 12 months prior to randomization OR
b. an asthma-related hospitalization (defined as an inpatient stay or a 24-hour stay in an observation area in an emergency room or other equivalent facility) between 30 days and 12 months prior to randomization
8. Questionnaire: Ability to answer questions regarding asthma status and quality of life and ability to use a daily electronic data capture system
Inhaler Usage: Ability to demonstrate proper use of a metered-dose inhaler and dry powder inhaler (DPI) device.
*Achieve Clinical Research conducts Phase II-IV Clinical Trials in Alabama. For more information about participating in an Asthma Clinical Study, please visit our website or contact us directly at (205) 380-6434.