NCT00367263

Evaluation of Traditional Paper Symptom Diary vs. the VOCEL Mobile Diary

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Allergy & Asthma Medical Group & Research Center · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Alvesco (Ciclesonide) 160 ug/day

Timeline

• Start date: 2006-10-01
• Completion: 2006-11-01
• First posted: 2006-08-22
• Last updated: 2007-05-02

Locations

1 site across 1 country: United States