search
Back to results

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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alvesco (Ciclesonide) 160 ug/day
Sponsored by
Allergy & Asthma Medical Group & Research Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or Female, 12 years of age and older. Females will be eligible only if they are: Surgically sterilized, post-menopausal (>1 year), abstinent, or practicing adequate method of birth control, and if they have a Negative urine pregnancy test (females of childbearing potential) 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: No inhaled corticosteroid therapy. Previous use of leukotriene receptor antagonists, and/or cromones, in addition to short acting bronchodilators are allowed.) Or, Inhaled corticosteroid therapy in monotherapy or in combination with a long acting beta agonist (LABA). Exclusion Criteria: Female subjects who are pregnant or trying to become pregnant Breast feeding Viral or bacterial respiratory tract infection within the last 14 days Tobacco smoking within the previous 6 months or greater than a lifetime 10 pack-year smoking history History of glaucoma, cataracts (lens opacities), retinal disease, or blindness Any serious concomitant disease such as cancer or serious renal, hepatic, cardiac, immunodeficiency, neurological, psychiatric, or other disease 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 Active or quiescent tuberculosis infections of the respiratory tract History of chronic bronchitis, COPD or emphysema History of alcohol abuse (more than 2 drinks/day on average) or drug abuse within the past 2 years Treatment with any investigational drug within the past 30 days 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). 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.

Sites / Locations

  • Allergy & Asthma Medical Group & Research Center

Outcomes

Primary Outcome Measures

To determine subject preference of a traditional paper symptom diary vs. the VOCEL® Mobile Diary.

Secondary Outcome Measures

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.
Change from baseline to end of treatment of peak expiratory flow.
Change from baseline to end of treatment of FEV1.
Determination of subject compliance with Alvesco® (ciclesonide), study medication dosing, as recorded on a traditional paper symptom diary and the VOCEL® Mobile Diary.
Determination of patient generated assessment of ease of use of Alvesco® (ciclesonide) in regards to learning, daily use and difficulties experienced.
Clinician generated assessment of the traditional paper diary and the VOCEL® Mobile Diary.

Full Information

First Posted
August 21, 2006
Last Updated
April 30, 2007
Sponsor
Allergy & Asthma Medical Group & Research Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00367263
Brief Title
Evaluation of Traditional Paper Symptom Diary vs. the VOCEL Mobile Diary
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 Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Allergy & Asthma Medical Group & Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Alvesco (Ciclesonide) 160 ug/day
Primary Outcome Measure Information:
Title
To determine subject preference of a traditional paper symptom diary vs. the VOCEL® Mobile Diary.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
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
Title
Change from baseline to end of treatment of peak expiratory flow.
Time Frame
1 month
Title
Change from baseline to end of treatment of FEV1.
Time Frame
1 month
Title
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
Title
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
Title
Clinician generated assessment of the traditional paper diary and the VOCEL® Mobile Diary.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or Female, 12 years of age and older. Females will be eligible only if they are: Surgically sterilized, post-menopausal (>1 year), abstinent, or practicing adequate method of birth control, and if they have a Negative urine pregnancy test (females of childbearing potential) 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: No inhaled corticosteroid therapy. Previous use of leukotriene receptor antagonists, and/or cromones, in addition to short acting bronchodilators are allowed.) Or, Inhaled corticosteroid therapy in monotherapy or in combination with a long acting beta agonist (LABA). Exclusion Criteria: Female subjects who are pregnant or trying to become pregnant Breast feeding Viral or bacterial respiratory tract infection within the last 14 days Tobacco smoking within the previous 6 months or greater than a lifetime 10 pack-year smoking history History of glaucoma, cataracts (lens opacities), retinal disease, or blindness Any serious concomitant disease such as cancer or serious renal, hepatic, cardiac, immunodeficiency, neurological, psychiatric, or other disease 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 Active or quiescent tuberculosis infections of the respiratory tract History of chronic bronchitis, COPD or emphysema History of alcohol abuse (more than 2 drinks/day on average) or drug abuse within the past 2 years Treatment with any investigational drug within the past 30 days 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). 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eli O Meltzer, MD
Organizational Affiliation
Allergy & Asthma Medical Group & Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergy & Asthma Medical Group & Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19412327
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs