Asthma Clinical Trial
Official title:
A Randomized Cross-Over Design Study Evaluating a Traditional Paper Symptom Diary vs. the VOCEL Mobile Diary in Subjects 12 Years and Older With Mild to Moderate Persistent Asthma Receiving Ciclesonide MDI (Alvesco) 80 ug BID
This study is designed to evaluate a traditional paper symptom diary system versus the VOCEL Mobile Diary. Subjects will be issued in a random order each system and asked their preference at the end of their participation.
Inflammation is the underlying pathophysiologic process causing asthma. Inhaled
corticosteroids are the first drugs of choice for treatment. Monotherapy with an ICS is most
often sufficient and, along with an as needed short acting bronchodilator agent, the most
cost effective method for managing patients with mild-moderate persistent asthma.
Alvesco, the ICS ciclesonide delivered in a solution via a HFA metered dose inhaler, has
been shown to be effective and safe for the treatment of persistent asthma. This study will
attempt to further document these attributes in patients with mild-moderate persistent
asthma.
The collection of patient reported data can be accomplished in a number of ways. The
standard system in asthma trials is daily diaries transcribed on paper forms. While useful
in many studies, this system lacks the ability to remind subject of reporting time, to time
stamp when the report is done and note at the time of report completion to the subject,
areas that are incomplete, and to remind patients when to take their study medication.
Because of these inadequacies, newer electronic data collection systems are being developed.
One of these, the VOCEL Mobile Diary system, will be compared with the standard paper
reporting method for abilities to document efficacy, safety, compliance and convenience.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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