Evaluation of Traditional Paper Symptom Diary vs. the VOCEL Mobile Diary
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|ClinicalTrials.gov Identifier: NCT00367263|
Recruitment Status : Completed
First Posted : August 22, 2006
Last Update Posted : May 2, 2007
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Alvesco (Ciclesonide) 160 ug/day||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2006|
|Actual Study Completion Date :||November 2006|
- To determine subject preference of a traditional paper symptom diary vs. the VOCEL® Mobile Diary. [ Time Frame: 1 month ]
- Asthma symptom scores (Daytime/Nighttime), nocturnal awakenings, Peak expiratory flow rate (PEFR) and use of rescue medication (albuterol metered dose inhaler) as recorded by the subject on the traditional paper diary and the VOCEL® Mobile Diary. [ Time Frame: 1 month ]
- Change from baseline to end of treatment of peak expiratory flow. [ Time Frame: 1 month ]
- Change from baseline to end of treatment of FEV1. [ Time Frame: 1 month ]
- Determination of subject compliance with Alvesco® (ciclesonide), study medication dosing, as recorded on a traditional paper symptom diary and the VOCEL® Mobile Diary. [ Time Frame: 1 month ]
- Determination of patient generated assessment of ease of use of Alvesco® (ciclesonide) in regards to learning, daily use and difficulties experienced. [ Time Frame: 1 month ]
- Clinician generated assessment of the traditional paper diary and the VOCEL® Mobile Diary. [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367263
|United States, California|
|Allergy & Asthma Medical Group & Research Center|
|San Diego, California, United States, 92123|
|Principal Investigator:||Eli O Meltzer, MD||Allergy & Asthma Medical Group & Research Center|