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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

Zurückgezogen

Bedingungen

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

Interventionell

Phase

  • Unzutreffend

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

5 Jahre bis 14 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

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

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

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

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

4. September 2011

Primärer Abschluss (Tatsächlich)

15. November 2013

Studienabschluss (Tatsächlich)

15. November 2013

Studienanmeldedaten

Zuerst eingereicht

10. September 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. November 2011

Zuerst gepostet (Schätzen)

10. November 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Dezember 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Dezember 2019

Zuletzt verifiziert

15. November 2013

Mehr Informationen

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 .

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