To Determine the Validity of the ACT in an Adolescent Population With Persistent Asthma

NCT02662413 | Completed

• 1 other identifier: 15-1804
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

To determine the measurement profiles of the asthma control test (ACT) in an adolescent population with persistent asthma.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Cohen's kappa

  To determine the agreement of the ACT score at the standard cutpoint of \>19 with physician assessment of control using Cohen's kappa.

  Baseline visit

Secondary Outcomes (3)

• Sensitivity of ACT Questionnaire

  follow-up visit (six weeks)

• Specificity of ACT Questionnaire

  follow-up visit (six weeks)

• Cohen's kappa

  follow-up visit (six weeks)

Interventions

Validation of Asthma Control Questionnaire OTHER

This is an observational study so there is no planned intervention.

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children ages 12-18 with a physician diagnosis of persistent asthma living in a defined geographical area

You may qualify if:

• Physician diagnosis of persistent asthma
• Current treatment with appropriate therapy for persistent asthma symptoms per the NHLBI guidelines including daily controller medication with at least low dose inhaled corticosteroids
• Must live within convenient driving distance of the North Carolina Children's Specialty Clinic in Raleigh North Carolina or the EPA Human Studies Facility on University of North Carolina Campus in Chapel Hill North Carolina.

You may not qualify if:

• Unable to perform spirometry
• Other medical history or underlying health problems that would preclude participation.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• American Academy of Allergy, Asthma, and Immunology: collaborator

Study Sites (2)

UNC Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27599-7310, United States

Location

NC Children's Specialty Clinic, 4414 Lake Boone Trail, Suite 505

Raleigh, North Carolina, 27607, United States

Location

Related Publications (13)

• Raherison C, Tunon-de-Lara JM, Vernejoux JM, Taytard A. Practical evaluation of asthma exacerbation self-management in children and adolescents. Respir Med. 2000 Nov;94(11):1047-52. doi: 10.1053/rmed.2000.0888.

  PMID: 11127490 BACKGROUND

• Larsen GL. Asthma in children. N Engl J Med. 1992 Jun 4;326(23):1540-5. doi: 10.1056/NEJM199206043262306.

  PMID: 1579137 BACKGROUND

• National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.

  PMID: 17983880 BACKGROUND

• Cloutier MM, Schatz M, Castro M, Clark N, Kelly HW, Mangione-Smith R, Sheller J, Sorkness C, Stoloff S, Gergen P. Asthma outcomes: composite scores of asthma control. J Allergy Clin Immunol. 2012 Mar;129(3 Suppl):S24-33. doi: 10.1016/j.jaci.2011.12.980.

  PMID: 22386507 BACKGROUND

• Juniper EF, Gruffydd-Jones K, Ward S, Svensson K. Asthma Control Questionnaire in children: validation, measurement properties, interpretation. Eur Respir J. 2010 Dec;36(6):1410-6. doi: 10.1183/09031936.00117509. Epub 2010 Jun 7.

  PMID: 20530041 BACKGROUND

• Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999 Oct;14(4):902-7. doi: 10.1034/j.1399-3003.1999.14d29.x.

  PMID: 10573240 BACKGROUND

• Korn S, Both J, Jung M, Hubner M, Taube C, Buhl R. Prospective evaluation of current asthma control using ACQ and ACT compared with GINA criteria. Ann Allergy Asthma Immunol. 2011 Dec;107(6):474-9. doi: 10.1016/j.anai.2011.09.001. Epub 2011 Oct 5.

  PMID: 22123375 BACKGROUND

• Schatz M, Sorkness CA, Li JT, Marcus P, Murray JJ, Nathan RA, Kosinski M, Pendergraft TB, Jhingran P. Asthma Control Test: reliability, validity, and responsiveness in patients not previously followed by asthma specialists. J Allergy Clin Immunol. 2006 Mar;117(3):549-56. doi: 10.1016/j.jaci.2006.01.011.

  PMID: 16522452 BACKGROUND

• Thomas M, Kay S, Pike J, Williams A, Rosenzweig JR, Hillyer EV, Price D. The Asthma Control Test (ACT) as a predictor of GINA guideline-defined asthma control: analysis of a multinational cross-sectional survey. Prim Care Respir J. 2009 Mar;18(1):41-9. doi: 10.4104/pcrj.2009.00010.

  PMID: 19240948 BACKGROUND

• Leung TF, Ko FW, Sy HY, Wong E, Li CY, Yung E, Hui DS, Wong GW, Lai CK. Identifying uncontrolled asthma in young children: clinical scores or objective variables? J Asthma. 2009 Mar;46(2):130-5. doi: 10.1080/02770900802468533.

  PMID: 19253117 BACKGROUND

• Koolen BB, Pijnenburg MW, Brackel HJ, Landstra AM, van den Berg NJ, Merkus PJ, Hop WC, Vaessen-Verberne AA. Comparing Global Initiative for Asthma (GINA) criteria with the Childhood Asthma Control Test (C-ACT) and Asthma Control Test (ACT). Eur Respir J. 2011 Sep;38(3):561-6. doi: 10.1183/09031936.00173710. Epub 2011 Mar 15.

  PMID: 21406508 BACKGROUND

• Shi Y, Tatavoosian AV, Aledia AS, George SC, Galant SP. Cut points for Asthma Control Tests in Mexican children in Orange County, California. Ann Allergy Asthma Immunol. 2012 Aug;109(2):108-13. doi: 10.1016/j.anai.2012.06.002. Epub 2012 Jul 4.

  PMID: 22840251 BACKGROUND

• Burbank AJ, Todoric K, Steele P, Rosen J, Zhou H, Frye M, Loughlin CE, Ivins S, Mills K, Massey LD, Reeve BB, Hernandez ML. Age and African-American race impact the validity and reliability of the asthma control test in persistent asthmatics. Respir Res. 2018 Aug 15;19(1):152. doi: 10.1186/s12931-018-0858-0.

  PMID: 30111326 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Allison Burbank, MD

  Fellow

  PRINCIPAL INVESTIGATOR

• Michelle Hernandez, MD

  Assistant Professor

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 25, 2016
• Study Start: January 1, 2016
• Primary Completion: August 10, 2017
• Study Completion: September 27, 2017
• Last Updated: March 23, 2018

Record last verified: 2018-03

Locations

US (2)