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

Completed · Not applicable

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00367263

Run by

Allergy & Asthma Medical Group & Research Center

People needed

12

Starts

2006-10-01

Expected to finish

2006-11-01

Last updated by the study team

2007-05-02

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Allergy & Asthma Medical Group & Research Center — San Diego, California, United States

Full record on ClinicalTrials.gov

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