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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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Change in the mean number of maximum asthma symptom days.
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Misure di risultato secondarie
Misura del risultato |
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Asthma-related medical care resource utilization, Lung function, Medication use, Cockroach Number and Allergen Reductions.
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 110230
- 11-E-0230
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .