Trial record 3 of 8 for:
NIAID | Open Studies | asthma
Asthma Phenotypes in the Inner City (APIC)
This study is currently recruiting participants.
Verified December 2012 by National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
First received: June 27, 2011
Last updated: December 4, 2012
Last verified: December 2012
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 of participants who have difficult to treat asthma and those who have easy to treat asthma. It is hoped that this study will provide information about these characteristics that will lead to better and improved treatment for individuals with asthma.
Drug: Flovent Diskus, Advair Diskus, Ventolin HFA, cetirizine, Flonase Nasal Spray, Singulair
||Observational Model: Cohort
Time Perspective: Cross-Sectional
||Asthma Phenotypes in the Inner City (ICAC-19)
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2014 (Final data collection date for primary outcome measure)
Subjects with asthma
Drug: Flovent Diskus, Advair Diskus, Ventolin HFA, cetirizine, Flonase Nasal Spray, Singulair
Asthma and rhinitis medication regimens based on NAEPP guidelines
|Ages Eligible for Study:
||6 Years to 17 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Inner city children with mild to severe asthma
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:
- Male or female aged 6-17 years, inclusive, at recruitment.
- Have a physician diagnosis of asthma.
- Have had 2 or more 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 trial enrollment (acceptable medical history and physical examination results).
- 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.
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 or more 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
- 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%, see Section 6.6 for 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, bronchiestasis, type 1 diabetes, hemophilia, Von Willebrands disease, sickle cell disease, cerebral palsy, rheumatoid arthritis, lupus, psoriasis, hyperimmunoglobulin E syndrome, parasite infections, 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383941
|National Jewish Health
|Denver, Colorado, United States, 80206 |
|Contact: Julie Henley 303-398-1608 email@example.com |
|Children's National Medical Center
|Washington, District of Columbia, United States, 20010 |
|Contact: Lisa Maltz 202-476-2943 firstname.lastname@example.org |
|Children's Memorial Hospital
|Chicago, Illinois, United States, 60614 |
|Contact: Sherri Willoughby 312-227-6457 ShWilloughby@childrensmemorial.org |
|Johns Hopkins University
|Baltimore, Maryland, United States, 2105 |
|Contact: Stephanie Leimenstoll 410-614-3525 email@example.com |
|Boston University School of Medicine
|Boston, Massachusetts, United States, 02118 |
|Contact: Lisa Gagalis 617-414-3263 firstname.lastname@example.org |
|Henry Ford Health Center
|Detroit, Michigan, United States, 48202 |
|Contact: Deborah Emmer 313-874-6267 email@example.com |
|Columbia University Medical Center
|New York, New York, United States, 10032 |
|Contact: Marcela Pierce 212-305-6255 firstname.lastname@example.org |
|Cincinnati Children's Hospital
|Cincinnati, Ohio, United States, 45202 |
|Contact: Tia Patterson 513-636-7171 Tia.Patterson@cchmc.org |
|University of Texas Southwestern Medical School
|Dallas, Texas, United States, 75390 |
|Contact: Rebecca Schutz 214-648-9029 email@example.com |
||William W. Busse, MD
||University of Wisconsin, Madison
No publications provided
||National Institute of Allergy and Infectious Diseases (NIAID)
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 27, 2011
||December 4, 2012
||United States: Federal Government
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2013
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases
Fluticasone, salmeterol drug combination
Reproductive Control Agents
Physiological Effects of Drugs
Adrenergic beta-2 Receptor Agonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Respiratory System Agents