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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alvesco (Ciclesonide) 160 ug/day | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To determine subject preference of a traditional paper symptom diary vs. the VOCEL® Mobile Diary. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month | |
| Change from baseline to end of treatment of peak expiratory flow. |
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Inclusion Criteria:
Male or Female, 12 years of age and older. Females will be eligible only if they are:
History of mild to moderate persistent asthma for at least 6 months as defined by NIH NHLBI April 19971.
At Visit 1 (Screening) treatment of subjects for the lat 30 days prior to screening must be:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eli O Meltzer, MD | Allergy & Asthma Medical Group & Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergy & Asthma Medical Group & Research Center | San Diego | California | 92123 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19412327 | Derived | Meltzer EO, Kelley N, Hovell MF. Randomized, cross-over evaluation of mobile phone vs paper diary in subjects with mild to moderate persistent asthma. Open Respir Med J. 2008;2:72-9. doi: 10.2174/1874306400802010072. Epub 2008 Sep 5. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C120481 | ciclesonide |
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| 1 month |
| Change from baseline to end of treatment of FEV1. | 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. | 1 month |
| Determination of patient generated assessment of ease of use of Alvesco® (ciclesonide) in regards to learning, daily use and difficulties experienced. | 1 month |
| Clinician generated assessment of the traditional paper diary and the VOCEL® Mobile Diary. | 1 month |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |