Status:
COMPLETED
Evaluation of Traditional Paper Symptom Diary vs. the VOCEL Mobile Diary
Lead Sponsor:
Allergy & Asthma Medical Group & Research Center
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
NA
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 o...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00367263
Start Date
October 1 2006
End Date
November 1 2006
Last Update
May 2 2007
Active Locations (1)
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1
Allergy & Asthma Medical Group & Research Center
San Diego, California, United States, 92123