Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00367263
Status:
COMPLETED
Last Update Posted:
2007-05-02
First Post:
2006-08-21
Brief Title:
Evaluation of Traditional Paper Symptom Diary vs the VOCEL Mobile Diary
Sponsor:
Allergy Asthma Medical Group Research Center
Organization:
Allergy Asthma Medical Group Research Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None