AsthmaAPICNCT01383941
Asthma Phenotypes in the Inner City
An observational study of Asthma and Rhinitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in United States.
Trial summary
This is an epidemiologic, multi-center, cross-sectional study to define the phenotypic characteristics of Difficult-to-Treat asthma, among children between the ages of 6 to 17 years, receiving one year of guidelines-based therapy for asthma and rhinitis/rhinosinusitis. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- What is being tested?
- Guidelines-based asthma and rhinitis/rhinosinusitis therapy
- How many people
- 717 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2011to Sep 2014
- Phase
- Observational
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Inner-city Asthma Consortium (ICAC) children with mild to severe asthma
Who may be able to join
- Participants who meet all of the following criteria are eligible for enrollment. Participants may be reassessed if not initially eligible. Participants are eligible if they:
- Are male or female ages 6-17 years, inclusive, at recruitment;
- Have a physician diagnosis of asthma;
- Have had ≥ 2 episodes of short-acting beta-agonist administration within the past 12 months, exclusive of use associated with exercise-induced symptoms;
- Have a primary place of residence located in one of the pre-selected recruitment census tracts as defined in the APIC Manual of Operations;
- Meet pretreatment eligibility requirements for study enrollment (acceptable medical history and physical examination results);
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- Have a parent or legal guardian who is willing to sign the written Informed Consent prior to initiation of any study procedure;
- Are willing to sign the assent form, if age appropriate;
- Have medical insurance at the Screening Visit. Coverage must be in effect from Screening through Enrollment in order to be enrolled.
Who cannot join
- Participants who meet any of the following criteria are not eligible for enrollment but may be reassessed. Participants are ineligible if they:
- Have had ≥ 2 life-threatening asthma exacerbations in the last 2 years requiring intubation or mechanical ventilation, or resulting in a hypoxic seizure;
- Are pregnant or lactating. (Females of child-bearing potential must remain abstinent or use a medically acceptable birth control method (e.g. oral, subcutaneous, mechanical, or surgical contraception) throughout the study. This is not for safety, but because it may be difficult to assess asthma control since lung function may change, making it difficult to interpret outcome measures);
- Will not allow the study clinician to manage their disease for the duration of the study or who are not willing to change their asthma medications to follow the protocol;
- Are unable to use a metered-dose inhaler (MDI) for administration of a beta-agonist rescue medication or use a dry powder inhaler (Diskus®) for the administration of asthma controller regimens;
- Are currently receiving hyposensitization therapy or have received hyposensitization therapy to any allergen in the past year prior to recruitment;
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- Are currently participating in an asthma-related pharmaceutical study or intervention study or who have participated in another asthma-related pharmaceutical study or intervention study in the month prior to recruitment;
- Do not sleep at least 4 nights per week in the same home;
- Have a sibling or other person living in the same home enrolled in the study;
- Live with a foster parent; not applicable if participant is able to provide consent;
- Do not have access to a phone (needed for scheduling appointments);
- Who are currently taking, or who have taken any of the following medications within 4 weeks of the Screening Visit (Visit -1): Monoamine oxidase inhibitors (phenelzine, tranylcypromine); Tricyclic and tetracyclic antidepressants; beta adrenergic blocker drugs (both oral and topical); Anticonvulsants (carbamazepine, phenobarbital, phenytoin, mephobarbital, primidone, ethosuximide, methsuximide, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, tiagabine, topiramate, valproic acid, divalproex sodium, zonisamide); Protease inhibitors (ritonavir, indinavir, nelfinavir); Calcium channel blockers (verapamil, diltiazem); Modafinil; Tamoxifen; non-nucleoside reverse transcriptase inhibitors; Macrolide antibiotics* (erythromycin, clarithromycin, dirithromycin, troleandomycin); chloramphenicol; nefazodone; aprepitant; St John's Wort; Rifampin*; Azole Antifungals* (ketoconazole, fluconazole, itraconazole); Sibutramine* ; bergamottin (constituent of grapefruit juice) (*may be rescreened if this therapy is short-lived);
- Should not be included in the study for any other reason, according to the investigator's discretion. This would include when, in the judgment of the investigator, the clinical care of the participant would be compromised by the treatment algorithm;
- Are receiving treatment with omalizumab, or have had omalizumab treatment within three months prior to screening;
- Are not able to perform spirometric pulmonary function tests (PFTs);
- Are not adherent to the controller medication between Visit 1 and Visit 0 (defined as medication use less than 50%, (Ref: Section 6.6 in study protocol- determining treatment adherence);
- Participants who meet any of the following criteria are not eligible for enrollment and may not be reassessed. Participants are ineligible if they:
- Do not primarily speak English (or Spanish at centers with Spanish speaking staff). Exclusion also applies to the child's caretaker;
- Plan to move from the area during the study period (13 months);
- Have any medical illnesses that in the opinion of the investigators would a.) increase the risk the subject would incur by participating in the study; b.) interfere with the measured outcomes of the study; or c.) interfere with the performance of the study procedures.
- Examples of such diseases are: phenylketonuria, cystic fibrosis, bronchiectasis, type 1 diabetes, hemophilia, Von Willebrand disease, sickle cell disease, cerebral palsy, rheumatoid arthritis, lupus, psoriasis, hyperimmunoglobulin E syndrome, parasite infection(s), Wiskott-Aldrich Syndrome or allergic bronchopulmonary aspergillosis;
- Have known hypersensitivity to any of the medications that will be used for the treatment of asthma or rhinitis;
- Have a current, severe hypersensitivity to milk;
- Have a current diagnosis of cancer, are currently being investigated for possible cancer, or who have a history of cancer.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Boston University School of Medicine
Boston, Massachusetts, 02118
Children's Memorial Hospital
Chicago, Illinois, 60614
Cincinnati Children's Hospital
Cincinnati, Ohio, 45202
University of Texas Southwestern Medical School
Dallas, Texas, 75390
National Jewish Health
Denver, Colorado, 80206
Henry Ford Health Center
Detroit, Michigan, 48202
Columbia University Medical Center
New York, New York, 10032
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Asthma Phenotypes in the Inner City (ICAC-19)
This is an epidemiologic, multi-center, cross-sectional study to define the phenotypic characteristics of Difficult-to-Treat asthma, among children between the ages of 6 to 17 years, receiving one year of guidelines-based therapy for asthma and rhinitis/rhinosinusitis.
Read the detailed description
Asthma is a complex, heritable disease that affects more than 11.2% of the U.S. population, which represents approximately 9 million children and 23 million adults. Although the underlying characteristics of asthma exist in virtually all patients, the clinical expression of the disease and response to treatment are highly variable.
The purpose of this study is to identify characteristics that will discriminate Difficult-to-Treat from Easy-to-Treat asthma in a defined inner-city population adherent to study-directed asthma treatment and management.
- Being tested
- Guidelines-based asthma and rhinitis/rhinosinusitis therapy
- Keywords
- asthma, rhinitis, difficult-to-treat asthmatic, phenotypes
- Medical subject headings
- Asthma, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guidelines-based asthma and rhinitis/rhinosinusitis therapyDrug
Also called asthma controller medications, rhinitis/rhinosinusitis controller medications
All participants receive standardized asthma and rhinitis treatment. Asthma and rhinitis medication regimens were based on 1.) the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report -3 (EPR-3) and 2.) the Rhinitis and its Impact on Asthma (ARIA) 2008 guidelines-derived treatment algorithms. References: 1.) J Allergy Clin Immunol 2007; Volume 120, Issue 5, Supplement s93-140. 2.) Allergy 2008; Volume 63, Issue Supplement s86, pages 7-160.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Mild to Severe Asthma | This is an epidemiologic, multi-center, cross-sectional study to define the phenotypic characteristics of Difficult-to-Treat asthma, among children receiving one year of guidelines-based therapy for asthma and rhinitis/rhinosinusitis. Receives: Drug: Guidelines-based asthma and rhinitis/rhinosinusitis therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotypic Identification: Discriminating Difficult-to-Treat from Easy-to-Treat Asthmatics In a Study Cohort
This study is not a clinical trial with a single disease outcome or endpoint. The objective is to determine distinct characteristics that will discriminate Difficult-to-Treat from Easy-to-Treat asthmatic children in a employing multiple domains. Statistical procedures will be used to assess the relative strength of multiple relationships among many variables simultaneously.
Measured: Baseline through 12 months of standardized asthma and rhinitis treatment
Secondary outcomes (2)
Identification of Asthma Phenotypes
Using cluster analysis techniques
Measured: Baseline through 12 months of standardized asthma and rhinitis treatment
Identification of Rhinitis Phenotypes
Using cluster analysis techniques
Measured: Baseline through 12 months of standardized asthma and rhinitis treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 717 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Inner-City Asthma Consortium
- Responsible party
- Sponsor
- Investigators
- William W. Busse, MD, Study chair, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383941
- Sponsor's protocol ID
- DAIT ICAC-19
- Acronym
- APIC
- Status last verified
- Mar 2017
- First submitted
- 27 Jun 2011
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pongracic JA, Krouse RZ, Babineau DC, Zoratti EM, Cohen RT, Wood RA, Khurana Hershey GK, Kercsmar CM, Gruchalla RS, Kattan M, Teach SJ, Johnson CC, Bacharier LB, Gern JE, Sigelman SM, Gergen PJ, Togias A, Visness CM, Busse WW, Liu AH. Distinguishing characteristics of difficult-to-control asthma in inner-city children and adolescents. J Allergy Clin Immunol. 2016 Oct;138(4):1030-1041. doi: 10.1016/j.jaci.2016.06.059.
PubMed 27720017Zoratti EM, Krouse RZ, Babineau DC, Pongracic JA, O'Connor GT, Wood RA, Khurana Hershey GK, Kercsmar CM, Gruchalla RS, Kattan M, Teach SJ, Sigelman SM, Gergen PJ, Togias A, Visness CM, Busse WW, Liu AH. Asthma phenotypes in inner-city children. J Allergy Clin Immunol. 2016 Oct;138(4):1016-1029. doi: 10.1016/j.jaci.2016.06.061.
PubMed 27720016Liu AH, Babineau DC, Krouse RZ, Zoratti EM, Pongracic JA, O'Connor GT, Wood RA, Khurana Hershey GK, Kercsmar CM, Gruchalla RS, Kattan M, Teach SJ, Makhija M, Pillai D, Lamm CI, Gern JE, Sigelman SM, Gergen PJ, Togias A, Visness CM, Busse WW. Pathways through which asthma risk factors contribute to asthma severity in inner-city children. J Allergy Clin Immunol. 2016 Oct;138(4):1042-1050. doi: 10.1016/j.jaci.2016.06.060.
PubMed 27720018
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Phenotypes in the Inner City (ICAC-19)
- ClinicalTrials.gov ID
- NCT01383941
- Acronym / sponsor ID
- APIC / DAIT ICAC-19
- Keywords
- asthma, rhinitis, difficult-to-treat asthmatic, phenotypes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 717 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Inner-City Asthma Consortium
- Study start
- Aug 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 28 Jun 2011 (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 is an epidemiologic, multi-center, cross-sectional study to define the phenotypic characteristics of Difficult-to-Treat asthma, among children between the ages of 6 to 17 years, receiving one year of guidelines-based therapy for asthma and rhinitis/rhinosinusitis.
Detailed description
Asthma is a complex, heritable disease that affects more than 11.2% of the U.S. population, which represents approximately 9 million children and 23 million adults. Although the underlying characteristics of asthma exist in virtually all patients, the clinical expression of the disease and response to treatment are highly variable.
The purpose of this study is to identify characteristics that will discriminate Difficult-to-Treat from Easy-to-Treat asthma in a defined inner-city population adherent to study-directed asthma treatment and management.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Mild to Severe Asthma | – | Drug: Guidelines-based asthma and rhinitis/rhinosinusitis therapyThis is an epidemiologic, multi-center, cross-sectional study to define the phenotypic characteristics of Difficult-to-Treat asthma, among children receiving one year of guidelines-based therapy for asthma and rhinitis/rhinosinusitis. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Inner-city Asthma Consortium (ICAC) children with mild to severe asthma
Key inclusion criteria (9 listed)
- Participants who meet all of the following criteria are eligible for enrollment. Participants may be reassessed if not initially eligible. Participants are eligible if they:
- Are male or female ages 6-17 years, inclusive, at recruitment;
- Have a physician diagnosis of asthma;
- Have had ≥ 2 episodes of short-acting beta-agonist administration within the past 12 months, exclusive of use associated with exercise-induced symptoms;
- Have a primary place of residence located in one of the pre-selected recruitment census tracts as defined in the APIC Manual of Operations;
Key exclusion criteria (24 listed)
- Participants who meet any of the following criteria are not eligible for enrollment but may be reassessed. Participants are ineligible if they:
- Have had ≥ 2 life-threatening asthma exacerbations in the last 2 years requiring intubation or mechanical ventilation, or resulting in a hypoxic seizure;
- Are pregnant or lactating. (Females of child-bearing potential must remain abstinent or use a medically acceptable birth control method (e.g. oral, subcutaneous, mechanical, or surgical contraception) throughout the study. This is not for safety, but because it may be difficult to assess asthma control since lung function may change, making it difficult to interpret outcome measures);
- Will not allow the study clinician to manage their disease for the duration of the study or who are not willing to change their asthma medications to follow the protocol;
- Are unable to use a metered-dose inhaler (MDI) for administration of a beta-agonist rescue medication or use a dry powder inhaler (Diskus®) 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 |
|---|---|---|
| Guidelines-based asthma and rhinitis/rhinosinusitis therapyAlso: asthma controller medications, rhinitis/rhinosinusitis controller medicationsAll participants receive standardized asthma and rhinitis treatment. Asthma and rhinitis medication regimens were based on 1.) the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report -3 (EPR-3) and 2.) the Rhinitis and its Impact on Asthma (ARIA) 2008 guidelines-derived treatment algorithms. References: 1.) J Allergy Clin Immunol 2007; Volume 120, Issue 5, Supplement s93-140. 2.) Allergy 2008; Volume 63, Issue Supplement s86, pages 7-160. | Drug | Subjects with Mild to Severe Asthma |
Primary outcome
Phenotypic Identification: Discriminating Difficult-to-Treat from Easy-to-Treat Asthmatics In a Study Cohort
Time frame: Baseline through 12 months of standardized asthma and rhinitis treatment
This study is not a clinical trial with a single disease outcome or endpoint. The objective is to determine distinct characteristics that will discriminate Difficult-to-Treat from Easy-to-Treat asthmatic children in a employing multiple domains. Statistical procedures will be used to assess the relative strength of multiple relationships among many variables simultaneously.
2 secondary outcomes
Identification of Asthma Phenotypes
Time frame: Baseline through 12 months of standardized asthma and rhinitis treatment
Identification of Rhinitis Phenotypes
Time frame: Baseline through 12 months of standardized asthma and rhinitis treatment
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 16 Mar 2017.
- Results publication: PubMed 27720017Pongracic JA, Krouse RZ, Babineau DC, Zoratti EM, Cohen RT, Wood RA, Khurana Hershey GK, Kercsmar CM, Gruchalla RS, Kattan M, Teach SJ, Johnson CC, Bacharier LB, Gern JE, Sigelman SM, Gergen PJ, Togias A, Visness CM, Busse WW, Liu AH. Distinguishing characteristics of difficult-to-control asthma in inner-city children and adolescents. J Allergy Clin Immunol. 2016 Oct;138(4):1030-1041. doi: 10.1016/j.jaci.2016.06.059.
- Results publication: PubMed 27720016Zoratti EM, Krouse RZ, Babineau DC, Pongracic JA, O'Connor GT, Wood RA, Khurana Hershey GK, Kercsmar CM, Gruchalla RS, Kattan M, Teach SJ, Sigelman SM, Gergen PJ, Togias A, Visness CM, Busse WW, Liu AH. Asthma phenotypes in inner-city children. J Allergy Clin Immunol. 2016 Oct;138(4):1016-1029. doi: 10.1016/j.jaci.2016.06.061.
- Results publication: PubMed 27720018Liu AH, Babineau DC, Krouse RZ, Zoratti EM, Pongracic JA, O'Connor GT, Wood RA, Khurana Hershey GK, Kercsmar CM, Gruchalla RS, Kattan M, Teach SJ, Makhija M, Pillai D, Lamm CI, Gern JE, Sigelman SM, Gergen PJ, Togias A, Visness CM, Busse WW. Pathways through which asthma risk factors contribute to asthma severity in inner-city children. J Allergy Clin Immunol. 2016 Oct;138(4):1042-1050. doi: 10.1016/j.jaci.2016.06.060.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- Description of Inner-city Asthma Consortium (ICAC)Link provided by the sponsor.
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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 W. Busse, MD study chair
University of Wisconsin, Madison
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Rhinitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 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 9 inclusion and 24 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 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Phenotypic Identification: Discriminating Difficult-to-Treat from Easy-to-Treat Asthmatics In a Study Cohort (time frame: Baseline through 12 months of standardized asthma and rhinitis treatment). 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 NCT01383941, which also lists 3 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 16 Mar 2017.