NCT00873873

Brief Summary

Distinct patterns of loss in pulmonary function were identified in children with mild to moderate asthma participating in a 10-year observation period during the NHLBI Childhood Asthma Management Program. This loss in pulmonary function is likely related to ongoing inflammation unresponsive to current therapy. This study will measure indicators of airway inflammation which are associated with structural and physiologic changes in the lung and provide insight into mechanisms of asthma progression in adolescence and early adulthood.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
7 months until next milestone

Results Posted

Study results publicly available

January 6, 2012

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

2.7 years

First QC Date

April 1, 2009

Results QC Date

November 27, 2011

Last Update Submit

October 19, 2020

Conditions

Asthma

Keywords

Asthma ProgressionAirway Wall ThicknessCorticosteroid ResistanceBiomarkersPulmonary Physiology

Outcome Measures

Primary Outcomes (1)

  • Airway Wall Thickness

    Segmental average airway wall thickness

    Measured at Year 2

Secondary Outcomes (1)

  • Protease/Antiprotease

    Measured at Year 2

Study Arms (4)

Persistent obstruction

(pattern of asthma progression)

Late obstruction

(pattern of asthma progression)

Late normal

(pattern of asthma progression)

Persistent normal

(pattern of asthma progression)

Eligibility Criteria

Age16 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants enrolled in CAMPCS/3 from various CAMP sites will be invited to participate in this study.

You may qualify if:

  • Must be enrolled in the CAMPCS/3 study; individuals enrolled in this study will represent four different patterns of asthma progression, as defined by forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) levels

You may not qualify if:

  • Unwilling to comply with study procedures
  • Physical state does not allow the study procedures to be performed (e.g., low pulmonary function for induced sputum, pregnancy for computerized tomography \[CT\] scan)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Related Publications (3)

  • Childhood Asthma Management Program Research Group; Szefler S, Weiss S, Tonascia J, Adkinson NF, Bender B, Cherniack R, Donithan M, Kelly HW, Reisman J, Shapiro GG, Sternberg AL, Strunk R, Taggart V, Van Natta M, Wise R, Wu M, Zeiger R. Long-term effects of budesonide or nedocromil in children with asthma. N Engl J Med. 2000 Oct 12;343(15):1054-63. doi: 10.1056/NEJM200010123431501.

    PMID: 11027739BACKGROUND

  • Covar RA, Spahn JD, Murphy JR, Szefler SJ; Childhood Asthma Management Program Research Group. Progression of asthma measured by lung function in the childhood asthma management program. Am J Respir Crit Care Med. 2004 Aug 1;170(3):234-41. doi: 10.1164/rccm.200308-1174OC. Epub 2004 Mar 17.

    PMID: 15028558BACKGROUND

  • Strunk RC, Weiss ST, Yates KP, Tonascia J, Zeiger RS, Szefler SJ; CAMP Research Group. Mild to moderate asthma affects lung growth in children and adolescents. J Allergy Clin Immunol. 2006 Nov;118(5):1040-7. doi: 10.1016/j.jaci.2006.07.053.

    PMID: 17088127BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Induced sputum, urine, blood, and exhaled breath condensates

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Limitations and Caveats

We had planned to extend invitations to the remaining 55 participants in a streamlined version of this protocol after analyzing the preliminary data and an additional cycle of CAMP was funded in 2007.

Results Point of Contact

Title
Head, Pediatric Clinical Pharmacology
Organization
National Jewish Health
szeflers@njhealth.org
303-398-1193

Study Officials

  • Stanley J. Szefler, MD

    National Jewish Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

April 1, 2009

First Posted

April 2, 2009

Study Start

September 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

October 22, 2020

Results First Posted

January 6, 2012

Record last verified: 2020-10

Locations

US(1)