- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01468805
Childhood Asthma Reduction Study
Background:
- Cockroach allergies are an important risk factor for asthma in inner-city households, especially in children. A new method for killing cockroaches may help children who live in households that have high numbers of cockroaches. Because most public health treatments target more than just cockroaches, this method could lower the costs of treating childhood allergies and asthma by focusing on the most likely source of the allergy.
Objectives:
- To test a new cockroach-killing method designed to reduce asthma in children exposed to cockroaches.
Eligibility:
- Children 5 to 14 years of age who have moderate to severe asthma.
- Children must live in a household that has a high number of cockroaches.
Design:
- Participants will be screened with a phone call and an initial home visit.
- Study doctors will place cockroach traps, and return after 3 days to check the number of roaches caught and killed. Dust samples will be collected from the house.
- Participants will have blood and lung function tests, and will be tested for allergies (including cockroach allergies).
- Some households will be treated for cockroaches at regular intervals, or more frequently if required by the study doctors.
- Participants will have regular checkup visits in their homes at months 1, 3, 6, 9, and 12 and short phone call interviews at months 2, 4, 6, 8 and 10 to study their asthma symptoms. The home visits will also check the cockroach levels in the house.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Asthma is the most prevalent chronic childhood condition and is the most frequent cause of hospitalization among children. There are about 6.7 million children in the U.S. who currently have asthma, and nearly two of every three of these children had at least one attack in the past 12 months. Evidence suggests that exposure to cockroach allergen might be the most important risk factor for asthma in inner-city households. An environmental intervention targeting only cockroach allergen could potentially provide cost savings in a public health program over high cost multi-component interventions, if it could be shown to reduce asthma morbidity.
The primary objective of the Childhood Asthma REduction Study (CARES) is to evaluate the effectiveness of a novel cockroach eradication method, shown in prior studies to drastically decrease cockroach allergen levels, in reducing asthma morbidity in children with moderate to severe asthma who are both allergic and exposed to cockroach allergen. Additionally, the study will characterize relationships between cockroach infestation and other environmental allergen exposures, and asthma morbidity, as well as consider dynamic relationships between cockroach counts and observed allergen reductions over time; and use study data to identify mechanisms such as cleaning behaviors that may influence those relationships.
These objectives will be addressed through a prospective, randomized controlled, multi-site intervention trial in which 414 eligible children age 5 to 14 years who live in households with a confirmed trap count of 30 or more cockroaches over a 3-day period, are randomly assigned to one of two treatment groups. Treatment will be implemented at multiple intervals in the homes of children assigned to the intervention group. Children in both the intervention and control groups will receive clinical evaluations for asthma, home assessments of allergen exposures, educational materials on allergen exposures and asthma, and information on study results. Following 12-months of active data collection, the extermination treatment will be made available to the homes of children in the control group. The target sample size is 372 participants completing the study, equally divided into the two arms. Home environmental assessments following the enrollment visit will take place at enrollment, 1, 3, 6, 9, and 12 months. Clinical assessments will also be conducted in the home at enrollment and the 12-month visit. Primary outcome data will be collected during scheduled follow up phone calls every two months.
Studientyp
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
- INCLUSION CRITERIA:
A child will be included in this study if the following criteria apply:
(Assessed during phone screening)
- Aged 5 to 14 years of age
- Physician diagnosis of asthma for at least one year prior to prescreening
- Parent/guardian able and willing to provide consent; child able and willing to provide assent
- Primary caretaker and child are able to speak English or Spanish
Moderate to severe asthma as defined by the child experiencing one of the following:
- One overnight hospitalization for asthma within the past 6 months,
OR
--Two unscheduled clinic or emergency department visits for asthma within the past 12 months
-Sleeps in the target home greater than or equal to 5 nights per week
(Assessed at beginning of enrollment/baseline visit)
- Target home has greater than or equal to 30 cockroaches trapped in a 3 day period
- Positive ImmunoCAP Rapid test result to cockroach allergen
EXCLUSION CRITERIA:
A child will be excluded from this study if the following criteria apply, as determined in the screening phone call and/or confirmed at the baseline visit:
The child has other serious medical or chronic illnesses, other than asthma, such as:
- Any hematologic, metabolic/endocrine, respiratory (other than asthma), cardiac or neurologic disorder requiring daily medications;
- Any severe behavioral problem that prohibits the child or the child s caregiver from answering questions or following instructions;
- Any autoimmune disease including rheumatoid arthritis, lupus, and myositis;
- Any immune deficiency;
- Any other serious medical condition such as juvenile diabetes mellitus, hypothyroidism, hyperthyroidism, cerebral palsy, hyperimmunoglobulin E syndrome, or diagnosed allergic bronchopulmonary aspergillosis.
- Plans to move within the 12 months of study enrollment
- Has no caregiver with access to a phone
Sibling or other household member currently participating in the study.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
---|
Change in the mean number of maximum asthma symptom days.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
---|
Asthma-related medical care resource utilization, Lung function, Medication use, Cockroach Number and Allergen Reductions.
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 110230
- 11-E-0230
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Asthma
-
Vanderbilt University Medical CenterNoch keine RekrutierungAsthma bei Kindern | Asthmaanfall | Asthma akut | Akute Asthma-Exazerbation | Asthma; StatusVereinigte Staaten
-
Parc de Salut MarAktiv, nicht rekrutierendAsthma bei Kindern | Anhaltendes Asthma | Asthma-ExazerbationSpanien
-
University of California, San FranciscoAbgeschlossenAsthma bei Kindern | Asthmaanfall | Asthma akut | Asthma chronischVereinigte Staaten
-
Skane University HospitalSwedish Heart Lung FoundationAbgeschlossenAtemfunktionstests
-
SingHealth PolyclinicsNoch keine RekrutierungAsthma | Asthma bei Kindern | Asthmaanfall | Asthma akut | Asthma chronisch
-
Brunel UniversityKarolinska InstitutetUnbekanntBelastungsinduziertes AsthmaVereinigtes Königreich
-
Universita di VeronaAbgeschlossen
-
Johann Wolfgang Goethe University HospitalAbgeschlossen
-
Johann Wolfgang Goethe University HospitalRekrutierungHausstaubmilbenallergie | Belastungsinduziertes AsthmaDeutschland
-
University of Sao PauloUniversity of Sao Paulo General HospitalUnbekanntAsthma beruflichBrasilien