NCT00367263

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Oct 2006

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

May 2, 2007

Status Verified

April 1, 2007

First QC Date

August 21, 2006

Last Update Submit

April 30, 2007

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

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

    1 month

Secondary Outcomes (6)

  • 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.

    1 month

  • Change from baseline to end of treatment of peak expiratory flow.

    1 month

  • Change from baseline to end of treatment of FEV1.

    1 month

  • Determination of subject compliance with Alvesco® (ciclesonide), study medication dosing, as recorded on a traditional paper symptom diary and the VOCEL® Mobile Diary.

    1 month

  • Determination of patient generated assessment of ease of use of Alvesco® (ciclesonide) in regards to learning, daily use and difficulties experienced.

    1 month

  • +1 more secondary outcomes

Interventions

Alvesco (Ciclesonide) 160 ug/dayDRUG

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allergy & Asthma Medical Group & Research Center

San Diego, California, 92123, United States

Location

Related Publications (1)

  • 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.

    PMID: 19412327DERIVED

MeSH Terms

Conditions

Asthma

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Eli O Meltzer, MD

    Allergy & Asthma Medical Group & Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 21, 2006

First Posted

August 22, 2006

Study Start

October 1, 2006

Study Completion

November 1, 2006

Last Updated

May 2, 2007

Record last verified: 2007-04

Locations

US(1)