Study of the Effect of Vitamin D as an Add-on Therapy to Corticosteroids in Asthma

NCT01248065 | Completed Phase 3 Results DMC

• 2 other identifiers: AsthmaNet 0011U10HL098115
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 16

Brief Summary

The purpose of the study is to find out if taking vitamin D in addition to an asthma controller medication helps to prevent worsening of asthma symptoms and asthma attacks.

Conditions

Asthma

Keywords

Asthma; Vitamin D; Corticosteroids; Treatment failure

Outcome Measures

Primary Outcomes (1)

• Treatment Failure

  Treatment failure is a well-defined asthma outcome reflecting overall asthma control that has been used previously in multiple clinical trials. Treatment failure as defined in the current proposal and prior trials is consistent with the American Thoracic Society (ATS)/European Respiratory Society(ERS) definition of a moderate exacerbation - a deterioration in symptoms and/or lung function with increased rescue bronchodilator use that lasts 2 days or more. The percentages of participants experiencing a treatment failure are Kaplan-Meier estimates of failure rate.

  Twenty-eight week intervention period from randomization until end of trial.

Secondary Outcomes (2)

• Lung Function Change From Baseline

  Change is measured as value at 28 weeks minus baseline value.

• Exacerbations

  Overall exacerbation rate during 28-week trial

Study Arms (2)

Ciclesonide + placebo

PLACEBO COMPARATOR

Drug: Ciclesonide

Ciclesonide + Vitamin D

EXPERIMENTAL

Drug: Vitamin D3; Drug: Ciclesonide

Interventions

Vitamin D3 DRUG

vitamin D (100,000 IU loading dose followed by 4,000 IU/day)

Ciclesonide + Vitamin D

Ciclesonide DRUG

Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)

Also known as: Alvesco®

Ciclesonide + Vitamin D; Ciclesonide + placebo

Eligibility Criteria

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

You may qualify if:

• Men and women 18 years of age and older
• Physician-diagnosed asthma for at least previous 12 months
• Asthma confirmed by: (a) β-agonist reversibility of forced expiratory volume in 1 second (FEV1) ≥12 % following 180 mcg (4 puffs) levalbuterol at visit 1 OR (b) methacholine provocative concentration causing a 20% fall in FEV1 (PC20) ≤ 8 mg/ml if not receiving an inhaled corticosteroid or ≤ 16 mg/ml if receiving an inhaled corticosteroid at visit 2. Source documentation for PC20 from an AsthmaNet methacholine challenge completed within 6 months of visit 2 will be accepted.
• Stable asthma controller therapy (inhaled corticosteroid or leukotriene modifier only) dose for past 2 weeks
• FEV1 ≥ 50% of predicted at visit 1
• Vitamin D level of less than 30 ng/ml at visit 0
• Experienced no more than one treatment failure in the VIDA run-in or oral corticosteroid (OCS) response periods on previous enrollments
• For women of childbearing potential: not pregnant, non-lactating, and agree to practice an adequate birth control method for the duration of the study

You may not qualify if:

• Taking vitamin D supplements containing \> 1000 IU/day of vitamin D
• Taking \>2500 mg/day calcium supplements
• Chronic oral corticosteroid therapy
• Chronic inhaled corticosteroid therapy \> 1,000 mcg of fluticasone daily or the equivalent
• History of physician-diagnosed nephrolithiasis
• Use of concomitant medications that alter vitamin D metabolism - phenytoin, phenobarbital, cardiac glycosides; or absorption - orlistat, cholestyramine, colestipol; or those that interfere with study endpoints
• Impaired renal function (GFR \< 30 ml/min)
• Asthma exacerbation within past 4 weeks requiring systemic corticosteroids
• Respiratory tract infection within past 4 weeks
• Chronic diseases (other than asthma)
• History of cigarette smoking within the past 1 year or \> 10 pack years total
• Serum calcium greater than 10.2 mg/dl on entry
• Urine calcium/creatinine ratio greater than 0.37 (urinary Ca and Creat in mg)

Sponsors & Collaborators

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

Study Sites (16)

University of California - San Francisco

San Francisco, California, 94143, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center/Stroger Hospital

Chicago, Illinois, 60612, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Duke University School of Medicine

Durham, North Carolina, 27110, United States

Location

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233, United States

Location

Related Publications (2)

• Jiao J, King TS, McKenzie M, Bacharier LB, Dixon AE, Codispoti CD, Dunn RM, Grossman NL, Lugogo NL, Ramratnam SK, Traister RS, Wechsler ME, Castro M; National Heart, Lung, and Blood Institute's AsthmaNet. Vitamin D3 therapy in patients with asthma complicated by sinonasal disease: Secondary analysis of the Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma trial. J Allergy Clin Immunol. 2016 Aug;138(2):589-592.e2. doi: 10.1016/j.jaci.2015.12.1329. Epub 2016 Mar 11. No abstract available.

  PMID: 26971692 DERIVED

• Castro M, King TS, Kunselman SJ, Cabana MD, Denlinger L, Holguin F, Kazani SD, Moore WC, Moy J, Sorkness CA, Avila P, Bacharier LB, Bleecker E, Boushey HA, Chmiel J, Fitzpatrick AM, Gentile D, Hundal M, Israel E, Kraft M, Krishnan JA, LaForce C, Lazarus SC, Lemanske R, Lugogo N, Martin RJ, Mauger DT, Naureckas E, Peters SP, Phipatanakul W, Que LG, Sheshadri A, Smith L, Solway J, Sullivan-Vedder L, Sumino K, Wechsler ME, Wenzel S, White SR, Sutherland ER; National Heart, Lung, and Blood Institute's AsthmaNet. Effect of vitamin D3 on asthma treatment failures in adults with symptomatic asthma and lower vitamin D levels: the VIDA randomized clinical trial. JAMA. 2014 May;311(20):2083-91. doi: 10.1001/jama.2014.5052.

  PMID: 24838406 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Cholecalciferol; ciclesonide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Tonya S. King, PhD
• Organization: Penn State University Dept. of Public Health Sciences

tking@psu.edu

717-531-7178

Study Officials

• David T. Mauger, PhD

  Pennsylvania State University College of Medicine

  PRINCIPAL INVESTIGATOR

• Elliot Israel, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Lewis Smith, MD

  Northwestern Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Julian Solway, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• James Moy, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Richard Martin, MD

  National Jewish Health

  PRINCIPAL INVESTIGATOR

• Christine Sorkness, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Elizabeth Bade, MD

  Aurora Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Sally Wenzel, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

• James Chmiel, MD

  Case Western Reserve University School of Medicine

  PRINCIPAL INVESTIGATOR

• Mario Castro, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Homer Boushey, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Monica Kraft, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Stephen Peters, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• W. Gerald Teague, MD

  University of Virginia Health System

  PRINCIPAL INVESTIGATOR

• Craig LaForce, MD

  North Carolina Clinical Research

  PRINCIPAL INVESTIGATOR

• Anne Fitzpatrick, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Jerry Krishnan, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, AsthmaNet Data Coordinating Center

Study Record Dates

• First Submitted: November 24, 2010
• First Posted: November 25, 2010
• Study Start: April 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: August 13, 2014
• Results First Posted: August 13, 2014

Record last verified: 2014-07

Locations

US (16)