AsthmaNCT00367263
Evaluation of Traditional Paper Symptom Diary vs. the VOCEL Mobile Diary
A study testing Alvesco (Ciclesonide) 160 ug/day in people with Asthma, run by Allergy & Asthma Medical Group & Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Alvesco (Ciclesonide) 160 ug/day
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Nov 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Allergy & Asthma Medical Group & Research Center
San Diego, California, 92123
About this study
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
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Alvesco (Ciclesonide) 160 ug/day
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alvesco (Ciclesonide) 160 ug/dayDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine subject preference of a traditional paper symptom diary vs. the VOCEL® Mobile Diary.
Measured: 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.
Measured: 1 month
Change from baseline to end of treatment of peak expiratory flow.
Measured: 1 month
Change from baseline to end of treatment of FEV1.
Measured: 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.
Measured: 1 month
Determination of patient generated assessment of ease of use of Alvesco® (ciclesonide) in regards to learning, daily use and difficulties experienced.
Measured: 1 month
Clinician generated assessment of the traditional paper diary and the VOCEL® Mobile Diary.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2006 (estimated)
- Study startOct 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergy & Asthma Medical Group & Research Center
- Sponsor type
- University, hospital or other
- Investigators
- Eli O Meltzer, MD, Principal investigator, Allergy & Asthma Medical Group & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367263
- Sponsor's protocol ID
- CICLE-L-01335
- Status last verified
- Apr 2007
- First submitted
- 21 Aug 2006
- Last updated
- 2 May 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19412327
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00367263
- Acronym / sponsor ID
- CICLE-L-01335
- Conditions
- Asthma
- Keywords
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Allergy & Asthma Medical Group & Research CenterUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Nov 2006 (actual)
- First posted
- 22 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male or Female, 12 years of age and older. Females will be eligible only if they are:
- 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).
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alvesco (Ciclesonide) 160 ug/day | Drug | – |
Primary outcome
To determine subject preference of a traditional paper symptom diary vs. the VOCEL® Mobile Diary.
Time frame: 1 month
6 secondary outcomes
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
Change from baseline to end of treatment of peak expiratory flow.
Time frame: 1 month
Change from baseline to end of treatment of FEV1.
Time frame: 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.
Time frame: 1 month
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
Clinician generated assessment of the traditional paper diary and the VOCEL® Mobile Diary.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2007.
- Derived from this study: PubMed 19412327Meltzer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eli O Meltzer, MD principal investigator
Allergy & Asthma Medical Group & Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alvesco (Ciclesonide) 160 ug/day in people with Asthma, run by Allergy & Asthma Medical Group & Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine subject preference of a traditional paper symptom diary vs. the VOCEL® Mobile Diary. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00367263, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2007.