AsthmaPhase 4OutcomesNCT00739219
Management of Asthma Patients Guided by Exhaled Nitric Oxide (eNO)
A Phase 4 study testing Apieron Insight eNO monitor in people with Asthma, run by Apieron at 12 sites in United States.
Trial summary
This study is designed to show that pharmacotherapy guided by eNO and clinical standard of care produces a superior outcome to trial-based therapy guided by clinical standard of care alone. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Apieron Insight eNO monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 12 sitesUnited States
- Study dates
- Dec 2006to Oct 2008
- Phase
- Phase 4
- 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
- Pre-existing diagnosis of asthma
- Persistent, moderate or severe asthma as classified by NAEPP
- Sub-optimally controlled asthma
- Initiated ICS therapy for at least the past 30 days and a history of improvement of asthma control on steroids
Who cannot join
- Active cigarette smoking or ≥ 10 pack-years smoking history
- Xolair taken in the past 6 months prior to enrollment
- Oral prednisone taken in the last 4 weeks prior to enrollment
- Cystic Fibrosis, COPD, ciliary dyskinesia, chest wall deformities or scoliosis
- Subject is currently enrolled in another investigational drug study
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Chesapeake Clinical Research
Baltimore, Maryland, 21236
Pharmaceutical Research & Consulting, Inc.
Dallas, Texas, 75231
Allergy Associates of Hartford
Glastonbury, Connecticut, 06033
Center for Allergy and Asthma
Highland Park, New Jersey, 08904
Allergy, Asthma & Dermatology Research Center, LLC
Lake Oswego, Oregon, 97035
Southern California Research
Mission Viejo, California, 92691
Asthma and Allergy Center of Chicago, S.C.
River Forest, Illinois, 60305
Allergy & Asthma Associates of Santa Clara Valley Research Center
San Jose, California, 95117
The Asthma- Allergy Clinic& Research Center
Shreveport, Louisiana, 71105
The Clinical Research Center, LLC
St Louis, Missouri, 63141
Pulmonary & Allergy Associates P.A.
Summit, New Jersey, 07901
Asthma & Allergy Research Associates
Upland, Pennsylvania, 19013
About this study
Official title: Management of Asthma Patients Guided by Exhaled Nitric Oxide (eNO) Using the Apieron NO Analyzer
This study is designed to show that pharmacotherapy guided by eNO and clinical standard of care produces a superior outcome to trial-based therapy guided by clinical standard of care alone.
Read the detailed description
Patients with persistent, moderate to severe asthma will be randomized to receive therapy guided by either eNO and clinical standard of care (eNO group) or clinical standard of care (control group). An eNO treatment algorithm will be established for each patient in the eNO group at Baseline (Visit 1). Enrollment is estimated to be six months with a follow up period of twelve months.
- Conditions
- Asthma
- Being tested
- Apieron Insight eNO monitor
- Keywords
- Asthma, inflammation, nitric oxide, eNO, FENO
- Medical subject headings
- Asthma, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apieron Insight eNO monitorDevice
The Apieron Insight(tm) eNO monitor is used to measure exhaled nitric oxide, and asthma is managed to keep eNO below an individualized target.
| Study group | Role | What they receive |
|---|---|---|
| eNO group | Active comparator | eNO measurement is used to inform asthma management decisions Receives: Device: Apieron Insight eNO monitor |
| control group | No intervention | Asthma is managed according to existing standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control days
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startDec 2006
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: Study terminated due to lack of care guidelines in the protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apieron
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William E Berger, MD, MBA, Principal investigator, Southern California Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739219
- Sponsor's protocol ID
- CP00006
- Acronym
- Outcomes
- Status last verified
- Oct 2008
- First submitted
- 19 Aug 2008
- Last updated
- 21 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Asthma Patients Guided by Exhaled Nitric Oxide (eNO) Using the Apieron NO Analyzer
- ClinicalTrials.gov ID
- NCT00739219
- Acronym / sponsor ID
- Outcomes / CP00006
- Conditions
- Asthma
- Keywords
- Asthma, inflammation, nitric oxide, eNO, FENO
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to lack of care guidelines in the protocol.
- Enrolment
- 260 participants (actual)
- Lead sponsor
- ApieronIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 21 Aug 2008 (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 show that pharmacotherapy guided by eNO and clinical standard of care produces a superior outcome to trial-based therapy guided by clinical standard of care alone.
Detailed description
Patients with persistent, moderate to severe asthma will be randomized to receive therapy guided by either eNO and clinical standard of care (eNO group) or clinical standard of care (control group). An eNO treatment algorithm will be established for each patient in the eNO group at Baseline (Visit 1). Enrollment is estimated to be six months with a follow up period of twelve months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eNO group | Active comparator | Device: Apieron Insight eNO monitoreNO measurement is used to inform asthma management decisions |
| control group | No intervention | –Asthma is managed according to existing standard of care |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Pre-existing diagnosis of asthma
- Persistent, moderate or severe asthma as classified by NAEPP
- Sub-optimally controlled asthma
- Initiated ICS therapy for at least the past 30 days and a history of improvement of asthma control on steroids
Key exclusion criteria (5 listed)
- Active cigarette smoking or ≥ 10 pack-years smoking history
- Xolair taken in the past 6 months prior to enrollment
- Oral prednisone taken in the last 4 weeks prior to enrollment
- Cystic Fibrosis, COPD, ciliary dyskinesia, chest wall deformities or scoliosis
- Subject is currently enrolled in another investigational drug study
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 |
|---|---|---|
| Apieron Insight eNO monitorThe Apieron Insight(tm) eNO monitor is used to measure exhaled nitric oxide, and asthma is managed to keep eNO below an individualized target. | Device | eNO group |
Primary outcome
Asthma control days
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Study terminated due to lack of care guidelines in the protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2009.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
William E Berger, MD, MBA principal investigator
Southern California Research
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apieron Insight eNO monitor in people with Asthma, run by Apieron at 12 sites 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 21 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to lack of care guidelines in the protocol.). Results are not available in the source record.
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?
Asthma control days (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2009.