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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
Sponsor:
Information provided by:
Allergy & Asthma Medical Group & Research Center

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Alvesco (Ciclesonide) 160 ug/day Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Ciclesonide




Primary Outcome Measures :
  1. To determine subject preference of a traditional paper symptom diary vs. the VOCEL® Mobile Diary. [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change from baseline to end of treatment of peak expiratory flow. [ Time Frame: 1 month ]
  3. Change from baseline to end of treatment of FEV1. [ Time Frame: 1 month ]
  4. 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 ]
  5. 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 ]
  6. Clinician generated assessment of the traditional paper diary and the VOCEL® Mobile Diary. [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or Female, 12 years of age and older. Females will be eligible only if they are:

    1. Surgically sterilized, post-menopausal (>1 year), abstinent, or practicing adequate method of birth control, and if they have a
    2. Negative urine pregnancy test (females of childbearing potential)
  2. 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:

  1. No inhaled corticosteroid therapy. Previous use of leukotriene receptor antagonists, and/or cromones, in addition to short acting bronchodilators are allowed.) Or,
  2. Inhaled corticosteroid therapy in monotherapy or in combination with a long acting beta agonist (LABA).

Exclusion Criteria:

  1. Female subjects who are pregnant or trying to become pregnant
  2. Breast feeding
  3. Viral or bacterial respiratory tract infection within the last 14 days
  4. Tobacco smoking within the previous 6 months or greater than a lifetime 10 pack-year smoking history
  5. History of glaucoma, cataracts (lens opacities), retinal disease, or blindness
  6. Any serious concomitant disease such as cancer or serious renal, hepatic, cardiac, immunodeficiency, neurological, psychiatric, or other disease
  7. Any medical condition that, in the judgment of the investigator, might interfere with the study, require treatment or make implementation of the protocol or interpretation of the study results difficult
  8. Active or quiescent tuberculosis infections of the respiratory tract
  9. History of chronic bronchitis, COPD or emphysema
  10. History of alcohol abuse (more than 2 drinks/day on average) or drug abuse within the past 2 years
  11. Treatment with any investigational drug within the past 30 days
  12. Subjects can be on maintenance immunotherapy but cannot have begun an immunotherapy regimen or have had a change in their immunotherapy regimen within 30 days prior to screening (Visit 1).
  13. Subjects may be on intranasal steroid if it has been maintained for 4 weeks prior to screen and a constant stable dose is maintained for the duration of the trial.

Information from the National Library of Medicine

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


Locations
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United States, California
Allergy & Asthma Medical Group & Research Center
San Diego, California, United States, 92123
Sponsors and Collaborators
Allergy & Asthma Medical Group & Research Center
Investigators
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Principal Investigator: Eli O Meltzer, MD Allergy & Asthma Medical Group & Research Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00367263    
Other Study ID Numbers: CICLE-L-01335
First Posted: August 22, 2006    Key Record Dates
Last Update Posted: May 2, 2007
Last Verified: April 2007
Keywords provided by Allergy & Asthma Medical Group & Research Center:
Asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ciclesonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents