NHLBI TOPMed: Childhood Asthma Management Program (CAMP)

This study is part of the NHLBI Trans-Omics for Precision Medicine (TOPMed) Whole Genome Sequencing Program. TOPMed is part of a broader Precision Medicine Initiative, which aims to provide disease treatments that are tailored to an individual's unique genes and environment. TOPMed will contribute to this initiative through the integration of whole-genome sequencing (WGS) and other -omics (e.g., metabolic profiles, protein and RNA expression patterns) data with molecular, behavioral, imaging, environmental, and clinical data. In doing so, this program aims to uncover factors that increase or decrease the risk of disease, to identify subtypes of disease, and to develop more targeted and personalized treatments. Two genotype call sets derived from WGS are now available, Freeze 8 (GRCh38) and Freeze 9b (GRCh38), with largely overlapping sample sets. Information about how to identify other TOPMed WGS accessions for cross-study analysis, as well as descriptions of TOPMed methods of data acquisition, data processing and quality control, are provided in the accompanying documents, "TOPMed Whole Genome Sequencing Project - Freeze 8, Phases 1-4" and "TOPMed Whole Genome Sequencing Project - Freeze 9b, Phases 1-4". Please check the study list at the top of each of these methods documents to determine whether it applies to this study accession.

The Childhood Asthma Management Program (CAMP) was designed to evaluate whether continuous, long-term treatment (over a period of four to six years) with either an inhaled corticosteroid (budesonide) or an inhaled noncorticosteroid drug (nedocromil) safely produces an improvement in lung growth as compared with treatment for symptoms only (with albuterol and, if necessary, prednisone, administered as needed). The primary outcome in the study was lung growth, as assessed by the change in forced expiratory volume in one second (FEV1, expressed as a percentage of the predicted value) after the administration of a bronchodilator. Secondary outcomes included the degree of airway responsiveness, morbidity, physical growth, and psychological development.

• Study Design:
  • Family/Twin/Trios
• Study Type:
  • Parent-Offspring Trios
• dbGaP estimated ancestry using GRAF-pop
• Subject Sample Telemetry Report (SSTR)

CAMP (Childhood Asthma Management Program):
Inclusion Criteria

• Aged 5 to 12 years at time of screening
• Chronic asthma as evidenced by one or more of the following historical findings for at least 6 months in the year prior to interview:
  • Asthma symptoms at least two times per week
  • At least two usages per week of an inhaled bronchodilator
  • Daily asthma medication
• Completion of a screening period (28 days) providing evidence of mild to moderate asthma as defined by criteria (see Table 2 in PMID: 10027502)
• Methacholine reactivity: FEV₁ PC20 no greater than 12.5 mg/mL
• Consent of parent or guardian
• Assent of child
• Ability to comply with trial for 5 to 6 years

• Severe asthma as evidenced by one or more of the following historical findings:
  • Two or more hospitalizations for asthma in the year prior to screening
  • Six or more steroid bursts in the year prior to screening
  • Intubation for asthma at any time in the past
• Presence of one or more of the following confounding or complicating conditions:
  • Other active pulmonary disease
  • Pulmonary function suggesting a ventilatory defect or evidence of irreversible lung disease
  • Severe chronic sinusitis or nasal polyposis
  • Introduction of, or a change in, allergen immunotherapy in the month prior to interview
  • Use of more than four sprays of nasal steroids daily (only beclomethasone allowed) at the time of randomization
  • Current use of cimetidine, metoclopramide, ranitidine, or other treatment for gastroesophageal reflux
  • Participation in another pharmaceutical, immunotherapy, respiratory, or asthma study
  • Pregnancy
• Inability to perform acceptable spirometry
• Inability to complete the methacholine challenge
• Evidence that the patient or family might be noncompliant or might move from the clinic area before completion of follow-up

• Primary Phenotype: Asthma

• BioProject
• Sequence Read Archive
• BioSample

• Principal Investigator
  • Scott T. Weiss. Brigham and Women's Hospital, Boston, MA, USA.