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

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergy & Asthma Medical Group & Research Center
• Treatments: Ciclesonide

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.