Asthma Clinical Research Network (ACRN)

NCT00000577 | Withdrawn Phase 3

• 17 other identifiers: 215U10HL074204U10HL051823U10HL051831U10HL051834U10HL051843U10HL051845U10HL056443U10HL074073U10HL074206U10HL074208U10HL074212U10HL074218U10HL074225U10HL074227U10HL074231Y02 HL51810
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 7

Brief Summary

This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma.

Conditions

Asthma; Lung Diseases

Interventions

Albuterol DRUG

Colchicine DRUG

Adrenal Cortex Hormones DRUG

Adrenergic-Beta Agonists DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Patients with asthma; specific eligibility criteria vary for each study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (7)

University of California at San Diego

La Jolla, California, 92103, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

National Jewish Medical & Research Center

Denver, Colorado, 80206, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27103, United States

Location

University of Wisconsin at Madison

Madison, Wisconsin, 53792, United States

Location

Related Publications (36)

• Kamada AK, Szefler SJ, Martin RJ, Boushey HA, Chinchilli VM, Drazen JM, Fish JE, Israel E, Lazarus SC, Lemanske RF. Issues in the use of inhaled glucocorticoids. The Asthma Clinical Research Network. Am J Respir Crit Care Med. 1996 Jun;153(6 Pt 1):1739-48. doi: 10.1164/ajrccm.153.6.8665030. No abstract available.

  PMID: 8665030 BACKGROUND

• Irvin CG, Martin RJ, Chinchilli VM, Kunselman SJ, Cherniack RM. Quality control of peak flow meters for multicenter clinical trials. The Asthma Clinical Research Network (ACRN). Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):396-402. doi: 10.1164/ajrccm.156.2.9609054.

  PMID: 9279215 BACKGROUND

• Martin RJ, Wanger JS, Irvin CG, Bucher Bartelson B, Cherniack RM. Methacholine challenge testing: safety of low starting FEV1. Asthma Clinical Research Network (ACRN). Chest. 1997 Jul;112(1):53-6. doi: 10.1378/chest.112.1.53.

  PMID: 9228357 BACKGROUND

• Fish JE, Peters SP, Chambers CV, McGeady SJ, Epstein KR, Boushey HA, Cherniack RM, Chinchilli VM, Drazen JM, Fahy JV, Hurd SS, Israel E, Lazarus SC, Lemanske RF, Martin RJ, Mauger EA, Sorkness C, Szefler SJ. An evaluation of colchicine as an alternative to inhaled corticosteriods in moderate asthma. National Heart, Lung, and Blood Institute's Asthma Clinical Research Network. Am J Respir Crit Care Med. 1997 Oct;156(4 Pt 1):1165-71. doi: 10.1164/ajrccm.156.4.9703012.

  PMID: 9351617 BACKGROUND

• Martin RJ, Pak J, Kunselman SJ, Cherniack RM. Assessment of the AirWatch lung function monitoring system. Asthma Clinical Research Network (ACRN). J Allergy Clin Immunol. 1999 Mar;103(3 Pt 1):535-6. doi: 10.1016/s0091-6749(99)70484-7. No abstract available.

  PMID: 10069893 BACKGROUND

• Drazen JM, Israel E, Boushey HA, Chinchilli VM, Fahy JV, Fish JE, Lazarus SC, Lemanske RF, Martin RJ, Peters SP, Sorkness C, Szefler SJ. Comparison of regularly scheduled with as-needed use of albuterol in mild asthma. Asthma Clinical Research Network. N Engl J Med. 1996 Sep 19;335(12):841-7. doi: 10.1056/NEJM199609193351202.

  PMID: 8778601 BACKGROUND

• Leone FT, Mauger EA, Peters SP, Chinchilli VM, Fish JE, Boushey HA, Cherniack RM, Drazen JM, Fahy JV, Ford J, Israel E, Lazarus SC, Lemanske RF, Martin RJ, McGeady SJ, Sorkness C, Szefler SJ; Asthma Clinical Research Network of the National Heart, Lung, and Blood Institute. The utility of peak flow, symptom scores, and beta-agonist use as outcome measures in asthma clinical research. Chest. 2001 Apr;119(4):1027-33. doi: 10.1378/chest.119.4.1027.

  PMID: 11296165 BACKGROUND

• Lemanske RF Jr, Sorkness CA, Mauger EA, Lazarus SC, Boushey HA, Fahy JV, Drazen JM, Chinchilli VM, Craig T, Fish JE, Ford JG, Israel E, Kraft M, Martin RJ, Nachman SA, Peters SP, Spahn JD, Szefler SJ; Asthma Clinical Research Network for the National Heart, Lung, and Blood Institute. Inhaled corticosteroid reduction and elimination in patients with persistent asthma receiving salmeterol: a randomized controlled trial. JAMA. 2001 May 23-30;285(20):2594-603. doi: 10.1001/jama.285.20.2594.

  PMID: 11368733 BACKGROUND

• Lazarus SC, Boushey HA, Fahy JV, Chinchilli VM, Lemanske RF Jr, Sorkness CA, Kraft M, Fish JE, Peters SP, Craig T, Drazen JM, Ford JG, Israel E, Martin RJ, Mauger EA, Nachman SA, Spahn JD, Szefler SJ; Asthma Clinical Research Network for the National Heart, Lung, and Blood Institute. Long-acting beta2-agonist monotherapy vs continued therapy with inhaled corticosteroids in patients with persistent asthma: a randomized controlled trial. JAMA. 2001 May 23-30;285(20):2583-93. doi: 10.1001/jama.285.20.2583.

  PMID: 11368732 BACKGROUND

• Israel E, Drazen JM, Liggett SB, Boushey HA, Cherniack RM, Chinchilli VM, Cooper DM, Fahy JV, Fish JE, Ford JG, Kraft M, Kunselman S, Lazarus SC, Lemanske RF, Martin RJ, McLean DE, Peters SP, Silverman EK, Sorkness CA, Szefler SJ, Weiss ST, Yandava CN. The effect of polymorphisms of the beta(2)-adrenergic receptor on the response to regular use of albuterol in asthma. Am J Respir Crit Care Med. 2000 Jul;162(1):75-80. doi: 10.1164/ajrccm.162.1.9907092.

  PMID: 10903223 BACKGROUND

• Israel E, Drazen JM, Liggett SB, Boushey HA, Cherniack RM, Chinchilli VM, Cooper DM, Fahy JV, Fish JE, Ford JG, Kraft M, Kunselman S, Lazarus SC, Lemanske RF Jr, Martin RJ, McLean DE, Peters SP, Silverman EK, Sorkness CA, Szefler SJ, Weiss ST, Yandava CN; National Heart, Lung, and Blood Institute's Asthma Clinical Research Network. Effect of polymorphism of the beta(2)-adrenergic receptor on response to regular use of albuterol in asthma. Int Arch Allergy Immunol. 2001 Jan-Mar;124(1-3):183-6. doi: 10.1159/000053705.

  PMID: 11306963 BACKGROUND

• Fahy JV, Boushey HA, Lazarus SC, Mauger EA, Cherniack RM, Chinchilli VM, Craig TJ, Drazen JM, Ford JG, Fish JE, Israel E, Kraft M, Lemanske RF, Martin RJ, McLean D, Peters SP, Sorkness C, Szefler SJ; NHLBI Asthma Clinical Research Network. Safety and reproducibility of sputum induction in asthmatic subjects in a multicenter study. Am J Respir Crit Care Med. 2001 May;163(6):1470-5. doi: 10.1164/ajrccm.163.6.9901105.

  PMID: 11371420 BACKGROUND

• King TS, Chinchilli VM. Robust estimators of the concordance correlation coefficient. J Biopharm Stat. 2001;11(3):83-105. doi: 10.1081/BIP-100107651.

  PMID: 11725932 BACKGROUND

• Sorkness CA, Ford JG, Lemanske RF Jr; Asthma Clinical Trials Network. Recruitment strategies in the Asthma Clinical Research Network. Control Clin Trials. 2001 Dec;22(6 Suppl):222S-35S. doi: 10.1016/s0197-2456(01)00172-6.

  PMID: 11728626 BACKGROUND

• Martin RJ, Kephart DK, Dyer AM, Fahy J, Kraft M; Asthma Clinical Trials Network. Quality control within the Asthma Clinical Research Network. Control Clin Trials. 2001 Dec;22(6 Suppl):207S-21S. doi: 10.1016/s0197-2456(01)00164-7.

  PMID: 11728625 BACKGROUND

• Forand PE, Kunselman SJ, Drazen JM, Israel E, Pillari A, Armstrong TJ, Britton TB; Asthma Clinical Trials Network. Genetic analysis in the Asthma Clinical Research Network. Control Clin Trials. 2001 Dec;22(6 Suppl):196S-206S. doi: 10.1016/s0197-2456(01)00163-5.

  PMID: 11728624 BACKGROUND

• Kunselman SJ, Armstrong TJ, Britton TB, Forand PE; Asthma Clinical Trials Network. Implementing randomization procedures in the asthma clinical research network. Control Clin Trials. 2001 Dec;22(6 Suppl):181S-95S. doi: 10.1016/s0197-2456(01)00162-3.

  PMID: 11728623 BACKGROUND

• Pogash RM, Boehmer SJ, Forand PE, Dyer AM, Kunselman SJ; Asthma Clinical Trials Network. Data management procedures in the Asthma Clinical Research Network. Control Clin Trials. 2001 Dec;22(6 Suppl):168S-80S. doi: 10.1016/s0197-2456(01)00170-2.

  PMID: 11728622 BACKGROUND

• Hess HM, Curley RM, Chinchilli VM, Cherniack RM, Evans RL; Asthma Clinical Trials Network. Modem remote support of pulmonary-function testing and quality control systems. Control Clin Trials. 2001 Dec;22(6 Suppl):156S-67S. doi: 10.1016/s0197-2456(01)00169-6.

  PMID: 11728621 BACKGROUND

• Curley RM, Evans RL, Kaylor J, Pogash RM, Chinchilli VM; Asthma Clinical Trials Network. Development and deployment of an internet-based data management system for use by the Asthma Clinical Research Network. Control Clin Trials. 2001 Dec;22(6 Suppl):135S-55S. doi: 10.1016/s0197-2456(01)00174-x.

  PMID: 11728620 BACKGROUND

• Chinchilli VM, Drazen JM, Fish JE, Lemanske RF Jr, Lazarus SC, Martin RJ; Asthma Clinical Trials Network. The clinical trials in the initial five-year award period of the Asthma Clinical Research Network. Control Clin Trials. 2001 Dec;22(6 Suppl):126S-34S. doi: 10.1016/s0197-2456(01)00160-x.

  PMID: 11728619 BACKGROUND

• Kephart DK, Chinchilli VM, Hurd SS, Cherniack RM; Asthma Clinical Trials Network. The organization of the Asthma Clinical Research Network: a multicenter, multiprotocol clinical trials team. Control Clin Trials. 2001 Dec;22(6 Suppl):119S-25S. doi: 10.1016/s0197-2456(01)00161-1.

  PMID: 11728618 BACKGROUND

• Chinchilli VM. The Asthma Clinical Research Network. Control Clin Trials. 2001 Dec;22(6 Suppl):117S-8S. doi: 10.1016/s0197-2456(01)00173-8. No abstract available.

  PMID: 11728617 BACKGROUND

• Janson SL, Alioto ME, Boushey HA; Asthma Clinical Trials Network. Attrition and retention of ethnically diverse subjects in a multicenter randomized controlled research trial. Control Clin Trials. 2001 Dec;22(6 Suppl):236S-43S. doi: 10.1016/s0197-2456(01)00171-4.

  PMID: 11728627 BACKGROUND

• Mauger EA, Mauger DT, Fish JE, Chinchilli VM, Israel E; Asthma Clinical Trials Network. Summarizing methacholine challenges in clinical research. Control Clin Trials. 2001 Dec;22(6 Suppl):244S-51S. doi: 10.1016/s0197-2456(01)00159-3.

  PMID: 11728628 BACKGROUND

• Martin RJ, Szefler SJ, Chinchilli VM, Kraft M, Dolovich M, Boushey HA, Cherniack RM, Craig TJ, Drazen JM, Fagan JK, Fahy JV, Fish JE, Ford JG, Israel E, Kunselman SJ, Lazarus SC, Lemanske RF Jr, Peters SP, Sorkness CA. Systemic effect comparisons of six inhaled corticosteroid preparations. Am J Respir Crit Care Med. 2002 May 15;165(10):1377-83. doi: 10.1164/rccm.2105013.

  PMID: 12016099 BACKGROUND

• Szefler SJ, Martin RJ, King TS, Boushey HA, Cherniack RM, Chinchilli VM, Craig TJ, Dolovich M, Drazen JM, Fagan JK, Fahy JV, Fish JE, Ford JG, Israel E, Kiley J, Kraft M, Lazarus SC, Lemanske RF Jr, Mauger E, Peters SP, Sorkness CA; Asthma Clinical Research Network of the National Heart Lung, and Blood Institute. Significant variability in response to inhaled corticosteroids for persistent asthma. J Allergy Clin Immunol. 2002 Mar;109(3):410-8. doi: 10.1067/mai.2002.122635.

  PMID: 11897984 BACKGROUND

• McEntegart D. Implementing randomization procedures in the Asthma Clinical Research Network. Control Clin Trials. 2002 Aug;23(4):424-6; author reply 426-8. doi: 10.1016/s0197-2456(02)00210-6. No abstract available.

  PMID: 12161085 BACKGROUND

• Kraft M, Martin RJ, Lazarus SC, Fahy JV, Boushey HA, Lemanske RF Jr, Szefler SJ; Asthma Clinical Research Network. Airway tissue mast cells in persistent asthma: predictor of treatment failure when patients discontinue inhaled corticosteroids. Chest. 2003 Jul;124(1):42-50. doi: 10.1378/chest.124.1.42.

  PMID: 12853500 BACKGROUND

• Burchard EG, Avila PC, Nazario S, Casal J, Torres A, Rodriguez-Santana JR, Toscano M, Sylvia JS, Alioto M, Salazar M, Gomez I, Fagan JK, Salas J, Lilly C, Matallana H, Ziv E, Castro R, Selman M, Chapela R, Sheppard D, Weiss ST, Ford JG, Boushey HA, Rodriguez-Cintron W, Drazen JM, Silverman EK; Genetics of Asthma in Latino Americans (GALA) Study. Lower bronchodilator responsiveness in Puerto Rican than in Mexican subjects with asthma. Am J Respir Crit Care Med. 2004 Feb 1;169(3):386-92. doi: 10.1164/rccm.200309-1293OC. Epub 2003 Nov 14.

  PMID: 14617512 BACKGROUND

• Lind DL, Choudhry S, Ung N, Ziv E, Avila PC, Salari K, Ha C, Lovins EG, Coyle NE, Nazario S, Casal J, Torres A, Rodriguez-Santana JR, Matallana H, Lilly CM, Salas J, Selman M, Boushey HA, Weiss ST, Chapela R, Ford JG, Rodriguez-Cintron W, Silverman EK, Sheppard D, Kwok PY, Gonzalez Burchard E. ADAM33 is not associated with asthma in Puerto Rican or Mexican populations. Am J Respir Crit Care Med. 2003 Dec 1;168(11):1312-6. doi: 10.1164/rccm.200306-877OC. Epub 2003 Sep 4.

  PMID: 12958057 BACKGROUND

• Tantisira KG, Lake S, Silverman ES, Palmer LJ, Lazarus R, Silverman EK, Liggett SB, Gelfand EW, Rosenwasser LJ, Richter B, Israel E, Wechsler M, Gabriel S, Altshuler D, Lander E, Drazen J, Weiss ST. Corticosteroid pharmacogenetics: association of sequence variants in CRHR1 with improved lung function in asthmatics treated with inhaled corticosteroids. Hum Mol Genet. 2004 Jul 1;13(13):1353-9. doi: 10.1093/hmg/ddh149. Epub 2004 May 5.

  PMID: 15128701 BACKGROUND

• Israel E, Chinchilli VM, Ford JG, Boushey HA, Cherniack R, Craig TJ, Deykin A, Fagan JK, Fahy JV, Fish J, Kraft M, Kunselman SJ, Lazarus SC, Lemanske RF Jr, Liggett SB, Martin RJ, Mitra N, Peters SP, Silverman E, Sorkness CA, Szefler SJ, Wechsler ME, Weiss ST, Drazen JM; National Heart, Lung, and Blood Institute's Asthma Clinical Research Network. Use of regularly scheduled albuterol treatment in asthma: genotype-stratified, randomised, placebo-controlled cross-over trial. Lancet. 2004 Oct 23-29;364(9444):1505-12. doi: 10.1016/S0140-6736(04)17273-5.

  PMID: 15500895 BACKGROUND

• Deykin A, Lazarus SC, Fahy JV, Wechsler ME, Boushey HA, Chinchilli VM, Craig TJ, Dimango E, Kraft M, Leone F, Lemanske RF, Martin RJ, Pesola GR, Peters SP, Sorkness CA, Szefler SJ, Israel E; Asthma Clinical Research Network, National Heart, Lung, and Blood Institute/NIH. Sputum eosinophil counts predict asthma control after discontinuation of inhaled corticosteroids. J Allergy Clin Immunol. 2005 Apr;115(4):720-7. doi: 10.1016/j.jaci.2004.12.1129.

  PMID: 15805990 BACKGROUND

• Boushey HA, Sorkness CA, King TS, Sullivan SD, Fahy JV, Lazarus SC, Chinchilli VM, Craig TJ, Dimango EA, Deykin A, Fagan JK, Fish JE, Ford JG, Kraft M, Lemanske RF Jr, Leone FT, Martin RJ, Mauger EA, Pesola GR, Peters SP, Rollings NJ, Szefler SJ, Wechsler ME, Israel E; National Heart, Lung, and Blood Institute's Asthma Clinical Research Network. Daily versus as-needed corticosteroids for mild persistent asthma. N Engl J Med. 2005 Apr 14;352(15):1519-28. doi: 10.1056/NEJMoa042552.

  PMID: 15829533 BACKGROUND

• Fabbri LM. Does mild persistent asthma require regular treatment? N Engl J Med. 2005 Apr 14;352(15):1589-91. doi: 10.1056/NEJMe058020. No abstract available.

  PMID: 15829540 BACKGROUND

Related Links

• Study Home Page

MeSH Terms

Conditions

Asthma; Lung Diseases

Interventions

Albuterol; Colchicine; Adrenal Cortex Hormones; Adrenergic beta-Agonists

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Alkaloids; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Homer A. Boushey

  University of California, San Francisco

  STUDY CHAIR

• William Calhoun

  University of Pittsburgh at Pittsburgh

  STUDY CHAIR

• Mario Castro

  Washington University School of Medicine

  STUDY CHAIR

• Vernon Chinchilli

  Milton S. Hershey Medical Center

  STUDY CHAIR

• Elliot Israel

  Brigham and Women's Hospital

  STUDY CHAIR

• Robert F. Lemanske, Jr.

  University of Wisconsin, Madison

  STUDY CHAIR

• Richard J. Martin

  National Jewish Medical & Research Center

  STUDY CHAIR

• Stephen P. Peters

  Wake Forest University Health Sciences

  STUDY CHAIR

• Stephen I. Wasserman

  University of California, San Diego

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: September 1, 1993
• Study Completion: July 1, 2008
• Last Updated: January 16, 2017

Record last verified: 2006-08

Locations

US (7)