AsthmaNCT00114413
Evaluation of an Asthma Treatment Strategy Based on Exhaled Nitric Oxide Measurements in Adolescents
A study testing Inhaled corticosteroids and eNO measurement in people with Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in United States.
Trial summary
The purpose of ICAC-01 is to determine whether an asthma treatment strategy that measures exhaled nitric oxide (eNO) to indicate disease progression is more effective in treating asthma symptoms when combined with existing asthma treatment guidelines than treatment using the guidelines alone. Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Inhaled corticosteroids and eNO measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 547 participants
- Where
- 12 sitesUnited States
- Study dates
- Aug 2004to 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 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Clinical diagnosis of asthma made by a doctor over a year prior to study entry OR symptoms have been present more than a year if the diagnosis was made less than a year prior to study entry
- Have symptoms consistent with persistent asthma OR have evidence of uncontrolled disease. More information on this criterion can be found in the DAIT ICAC-01 protocol.
- Currently reside in a pre-selected area containing at least 20% of households below the U.S. government poverty level
- Do not smoke and have not used smokeless tobacco products in the year prior to study entry
- Able to perform eNO measurement procedures and spirometry at study screening
- Parent or guardian willing to provide informed consent, if applicable
Show all 12Show fewer
- History of clinical varicella (chicken pox) or have received varicella vaccine
- Planning to stay in the area for the next 12 months
- Primary language is English. Spanish speakers may enroll at centers with Spanish-speaking staff.
- Parent or guardian primarily speaks English (or Spanish at centers with Spanish-speaking staff), for participants with parent or guardian providing informed consent
- Willing to allow the study physician to manage disease for the duration of the study
- Willing to change asthma medications in order to follow the protocol
Who cannot join
- Adherence to controller medication between Visits 1 and 2 is less than 25%. More information on this criterion can be found in the DAIT ICAC-01 protocol.
- Determined to have mild intermittent asthma at Visit 1
- Have had a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure in the 5 years prior to study entry
- Have significant medical illnesses other than asthma. More information on this criterion can be found in the DAIT ICAC-01 protocol.
- Unable to use a metered-dose inhaler for administration of a beta-agonist rescue medication or a dry powder inhaler for the administration of asthma controller regimens
- Known hypersensitivity to any medications commonly used for the treatment of asthma
Show all 14Show fewer
- Have not completed a home evaluation within 4 weeks of study screening
- Currently participating in another asthma-related drug or intervention study, or have participated in another asthma-related drug or intervention study in the month prior to study entry
- Does not sleep at least 4 nights per week in one home
- Lives with a foster parent (not applicable if patient is able to provide informed consent)
- Does not have access to a phone
- Requires certain medications. More information on this criterion can be found in the DAIT ICAC-01 protocol.
- Urine cotinine level above 100 ng/ml at study screening
- Pregnant or breastfeeding
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Johns Hopkins University
Baltimore, Maryland, 21205
Boston University School of Medicine
Boston, Massachusetts, 02118
Rho Federal System Division, Inc- data coordinating center
Chapel Hill, North Carolina, 27517
Children's Memorial Hospital
Chicago, Illinois, 60614
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
University of Texas Southwestern (DAIT-ICAC-01/02)
Dallas, Texas, 75235
National Jewish Medical and Research Center (DAIT-ICAC-01/02)
Denver, Colorado, 80206
University of Wisconsin-an administrative site
Madison, Wisconsin, 53792
Mount Sinai (DAIT-ICAC-01/02)
New York, New York, 10032
Washington University School of Medicine
St Louis, Missouri, 63110
University of Arizona (DAIT-ICAC-01/02)
Tucson, Arizona, 85724
Howard University
Washington D.C., District of Columbia, 20010
About this study
Official title: Asthma Control Evaluation (ACE): A Biomarker-Based Approach to Improving Asthma Control and Mechanistic Studies (DAIT ICAC-02)
The purpose of ICAC-01 is to determine whether an asthma treatment strategy that measures exhaled nitric oxide (eNO) to indicate disease progression is more effective in treating asthma symptoms when combined with existing asthma treatment guidelines than treatment using the guidelines alone.
Read the detailed description
Over the past two decades, the prevalence of asthma has dramatically increased in many parts of the world. The current National Asthma Education and Prevention Program (NAEPP) identifies inhaled corticosteroids (ICS) as the preferred long-term control therapy for all forms of persistent asthma. However, there is still a significant proportion of patients with persistent asthma who are not receiving ICS therapy or do not follow their treatment plan. Individualized asthma treatment plans are needed. The use of biomarkers, in addition to NAEPP guidelines, may help enhance the level of asthma assessment, guide medication regimens, and improve overall asthma control. This study will determine whether NAEPP-recommended treatment, combined with eNO measurement, is more effective in reducing asthma symptoms than NAEPP-recommended treatment alone. ICAC-01 will last 46 weeks and will comprise 8 study visits.
ICAC-01 also includes a mechanistic sub-study (ICAC-02). Its primary objective is to determine whether "highly sensitized", compared to "weakly sensitized" asthmatic subjects have more severe asthma, as defined by the levels at randomization to the completion of ICAC-01. To address the primary objective of ICAC-02, the study will include all the participants enrolled in ICAC-01 with dust mite-, cockroach- and/or alternaria-specific IgE levels within certain parameters.
- Conditions
- Asthma
- Being tested
- Inhaled corticosteroids, eNO measurement
- Keywords
- Exhaled Nitric Oxide, Lung, Urban Health, Child, Adolescent
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled corticosteroidsDrug
Used for both regular asthma control and as a rescue inhaler
eNO measurementProcedure or surgery
measured by Aerocrine® NIOX device
| Study group | Role | What they receive |
|---|---|---|
| Reference Strategy | Active comparator | Participants in the reference strategy group will undergo the eNO procedure but will follow NAEPP guidelines alone for asthma treatment without eNO measurements for the rest of the study. Receives: Drug: Inhaled corticosteroids |
| Biomarker Strategy | Experimental | Participants in the biomarker strategy group will follow NAEPP treatment guidelines, as well as eNO measurements, to determine asthma treatment at each study visit. Receives: Drug: Inhaled corticosteroids; Procedure: eNO measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean maximum symptom days per 2 weeks, as assessed by questionnaire
Measured: At Visits 3 and 8
Secondary outcomes (9)
Days with wheeze
Measured: Throughout study
Days of slowed down or discontinued physical activities due to asthma
Measured: Throughout study
Nights awoken due to asthma
Measured: Throughout study
Days on which plans were changed due to asthma
Measured: Throughout study
Days missed school/work due to asthma
Measured: Throughout study
Unscheduled office/clinic visit due to asthma
Measured: Throughout study
Emergency room/urgent care center due to asthma
Measured: Throughout study
Hospitalization due to asthma
Measured: Throughout study
Number of asthma exacerbations requiring prednisone or prednisone equivalent
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2005 (estimated)
- Study startAug 2004
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 547 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- William Busse, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114413
- Sponsor's protocol ID
- DAIT ICAC-01/DAIT ICAC-02
- Status last verified
- Feb 2017
- First submitted
- 14 Jun 2005
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Publications
Reid DW, Johns DP, Feltis B, Ward C, Walters EH. Exhaled nitric oxide continues to reflect airway hyperresponsiveness and disease activity in inhaled corticosteroid-treated adult asthmatic patients. Respirology. 2003 Dec;8(4):479-86. doi: 10.1046/j.1440-1843.2003.00495.x.
PubMed 14629652Strunk RC, Szefler SJ, Phillips BR, Zeiger RS, Chinchilli VM, Larsen G, Hodgdon K, Morgan W, Sorkness CA, Lemanske RF Jr; Childhood Asthma Research and Education Network of the National Heart, Lung, and Blood Institute. Relationship of exhaled nitric oxide to clinical and inflammatory markers of persistent asthma in children. J Allergy Clin Immunol. 2003 Nov;112(5):883-92. doi: 10.1016/j.jaci.2003.08.014.
PubMed 14610474Langley SJ, Goldthorpe S, Custovic A, Woodcock A. Relationship among pulmonary function, bronchial reactivity, and exhaled nitric oxide in a large group of asthmatic patients. Ann Allergy Asthma Immunol. 2003 Oct;91(4):398-404. doi: 10.1016/S1081-1206(10)61688-2.
PubMed 14582820Jones SL, Herbison P, Cowan JO, Flannery EM, Hancox RJ, McLachlan CR, Taylor DR. Exhaled NO and assessment of anti-inflammatory effects of inhaled steroid: dose-response relationship. Eur Respir J. 2002 Sep;20(3):601-8. doi: 10.1183/09031936.02.00285302.
PubMed 12358335Szefler SJ, Mitchell H, Sorkness CA, Gergen PJ, O'Connor GT, Morgan WJ, Kattan M, Pongracic JA, Teach SJ, Bloomberg GR, Eggleston PA, Gruchalla RS, Kercsmar CM, Liu AH, Wildfire JJ, Curry MD, Busse WW. Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults: a randomised controlled trial. Lancet. 2008 Sep 20;372(9643):1065-72. doi: 10.1016/S0140-6736(08)61448-8.
PubMed 18805335Arroyave WD, Rabito FA, Carlson JC, Sever ML, Lefante J. Asthma severity, not asthma control, is worse in atopic compared with nonatopic adolescents with asthma. Ann Allergy Asthma Immunol. 2016 Jan;116(1):18-25. doi: 10.1016/j.anai.2015.10.015. Epub 2015 Nov 7.
PubMed 26560898
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Control Evaluation (ACE): A Biomarker-Based Approach to Improving Asthma Control and Mechanistic Studies (DAIT ICAC-02)
- ClinicalTrials.gov ID
- NCT00114413
- Acronym / sponsor ID
- DAIT ICAC-01/DAIT ICAC-02
- Conditions
- Asthma
- Keywords
- Exhaled Nitric Oxide, Lung, Urban Health, Child, Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 547 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Aug 2004
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 15 Jun 2005 (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.
The purpose of ICAC-01 is to determine whether an asthma treatment strategy that measures exhaled nitric oxide (eNO) to indicate disease progression is more effective in treating asthma symptoms when combined with existing asthma treatment guidelines than treatment using the guidelines alone.
Detailed description
Over the past two decades, the prevalence of asthma has dramatically increased in many parts of the world. The current National Asthma Education and Prevention Program (NAEPP) identifies inhaled corticosteroids (ICS) as the preferred long-term control therapy for all forms of persistent asthma. However, there is still a significant proportion of patients with persistent asthma who are not receiving ICS therapy or do not follow their treatment plan. Individualized asthma treatment plans are needed. The use of biomarkers, in addition to NAEPP guidelines, may help enhance the level of asthma assessment, guide medication regimens, and improve overall asthma control. This study will determine whether NAEPP-recommended treatment, combined with eNO measurement, is more effective in reducing asthma symptoms than NAEPP-recommended treatment alone. ICAC-01 will last 46 weeks and will comprise 8 study visits.
ICAC-01 also includes a mechanistic sub-study (ICAC-02). Its primary objective is to determine whether "highly sensitized", compared to "weakly sensitized" asthmatic subjects have more severe asthma, as defined by the levels at randomization to the completion of ICAC-01. To address the primary objective of ICAC-02, the study will include all the participants enrolled in ICAC-01 with dust mite-, cockroach- and/or alternaria-specific IgE levels within certain parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference Strategy | Active comparator | Drug: Inhaled corticosteroidsParticipants in the reference strategy group will undergo the eNO procedure but will follow NAEPP guidelines alone for asthma treatment without eNO measurements for the rest of the study. |
| Biomarker Strategy | Experimental | Drug: Inhaled corticosteroids, Procedure: eNO measurementParticipants in the biomarker strategy group will follow NAEPP treatment guidelines, as well as eNO measurements, to determine asthma treatment at each study visit. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Clinical diagnosis of asthma made by a doctor over a year prior to study entry OR symptoms have been present more than a year if the diagnosis was made less than a year prior to study entry
- Have symptoms consistent with persistent asthma OR have evidence of uncontrolled disease. More information on this criterion can be found in the DAIT ICAC-01 protocol.
- Currently reside in a pre-selected area containing at least 20% of households below the U.S. government poverty level
- Do not smoke and have not used smokeless tobacco products in the year prior to study entry
- Able to perform eNO measurement procedures and spirometry at study screening
Key exclusion criteria (14 listed)
- Adherence to controller medication between Visits 1 and 2 is less than 25%. More information on this criterion can be found in the DAIT ICAC-01 protocol.
- Determined to have mild intermittent asthma at Visit 1
- Have had a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure in the 5 years prior to study entry
- Have significant medical illnesses other than asthma. More information on this criterion can be found in the DAIT ICAC-01 protocol.
- Unable to use a metered-dose inhaler for administration of a beta-agonist rescue medication or a dry powder inhaler for the administration of asthma controller regimens
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 |
|---|---|---|
| Inhaled corticosteroidsUsed for both regular asthma control and as a rescue inhaler | Drug | Biomarker Strategy, Reference Strategy |
| eNO measurementmeasured by Aerocrine® NIOX device | Procedure or surgery | Biomarker Strategy |
Primary outcome
Mean maximum symptom days per 2 weeks, as assessed by questionnaire
Time frame: At Visits 3 and 8
9 secondary outcomes
Days with wheeze
Time frame: Throughout study
Days of slowed down or discontinued physical activities due to asthma
Time frame: Throughout study
Nights awoken due to asthma
Time frame: Throughout study
Days on which plans were changed due to asthma
Time frame: Throughout study
Days missed school/work due to asthma
Time frame: Throughout study
Unscheduled office/clinic visit due to asthma
Time frame: Throughout study
Emergency room/urgent care center due to asthma
Time frame: Throughout study
Hospitalization due to asthma
Time frame: Throughout study
Number of asthma exacerbations requiring prednisone or prednisone equivalent
Time frame: Throughout study
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 10 Feb 2017.
- Background: PubMed 14629652Reid DW, Johns DP, Feltis B, Ward C, Walters EH. Exhaled nitric oxide continues to reflect airway hyperresponsiveness and disease activity in inhaled corticosteroid-treated adult asthmatic patients. Respirology. 2003 Dec;8(4):479-86. doi: 10.1046/j.1440-1843.2003.00495.x.
- Background: PubMed 14610474Strunk RC, Szefler SJ, Phillips BR, Zeiger RS, Chinchilli VM, Larsen G, Hodgdon K, Morgan W, Sorkness CA, Lemanske RF Jr; Childhood Asthma Research and Education Network of the National Heart, Lung, and Blood Institute. Relationship of exhaled nitric oxide to clinical and inflammatory markers of persistent asthma in children. J Allergy Clin Immunol. 2003 Nov;112(5):883-92. doi: 10.1016/j.jaci.2003.08.014.
- Background: PubMed 14582820Langley SJ, Goldthorpe S, Custovic A, Woodcock A. Relationship among pulmonary function, bronchial reactivity, and exhaled nitric oxide in a large group of asthmatic patients. Ann Allergy Asthma Immunol. 2003 Oct;91(4):398-404. doi: 10.1016/S1081-1206(10)61688-2.
- Background: PubMed 12358335Jones SL, Herbison P, Cowan JO, Flannery EM, Hancox RJ, McLachlan CR, Taylor DR. Exhaled NO and assessment of anti-inflammatory effects of inhaled steroid: dose-response relationship. Eur Respir J. 2002 Sep;20(3):601-8. doi: 10.1183/09031936.02.00285302.
- Results publication: PubMed 18805335Szefler SJ, Mitchell H, Sorkness CA, Gergen PJ, O'Connor GT, Morgan WJ, Kattan M, Pongracic JA, Teach SJ, Bloomberg GR, Eggleston PA, Gruchalla RS, Kercsmar CM, Liu AH, Wildfire JJ, Curry MD, Busse WW. Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults: a randomised controlled trial. Lancet. 2008 Sep 20;372(9643):1065-72. doi: 10.1016/S0140-6736(08)61448-8.
- Results publication: PubMed 26560898Arroyave WD, Rabito FA, Carlson JC, Sever ML, Lefante J. Asthma severity, not asthma control, is worse in atopic compared with nonatopic adolescents with asthma. Ann Allergy Asthma Immunol. 2016 Jan;116(1):18-25. doi: 10.1016/j.anai.2015.10.015. Epub 2015 Nov 7.
- National Institute of Allergy and Infectious Diseases (NIAID) websiteLink provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT) websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
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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.
William Busse, MD principal investigator
University of Wisconsin, Madison
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhaled corticosteroids and eNO measurement in people with Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 12 inclusion and 14 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 10 Feb 2017. 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.
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?
Mean maximum symptom days per 2 weeks, as assessed by questionnaire (time frame: At Visits 3 and 8). 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 NCT00114413, which also lists 6 linked publications.
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 10 Feb 2017.