NCT00495157

Brief Summary

Asthma can be effectively controlled using inhaled corticosteroid medication. Treatment with inhaled corticosteroids often requires periodic adjustments to medication dosing and frequency levels. This study examines whether it is more beneficial to adjust corticosteroid treatment based on asthma symptoms and/or biomarkers of lung function versus standard medical guidelines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
342

participants targeted

Target at P25-P50 for phase_3 asthma

Timeline
Completed

Started Jun 2007

Longer than P75 for phase_3 asthma

Geographic Reach
1 country

10 active sites

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

June 1, 2007

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 31, 2012

Completed
Last Updated

April 11, 2013

Status Verified

April 1, 2013

Enrollment Period

3.1 years

First QC Date

June 28, 2007

Results QC Date

April 30, 2012

Last Update Submit

April 5, 2013

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Time to Treatment Failure (Measured in Days)

    Measured during the 36-week treatment period

Secondary Outcomes (8)

  • Number of Episodes of Treatment Failure

    Measured during the 36-week treatment period

  • Time to First Asthma Exacerbation

    Measured during the 36-week treatment period

  • Number of Asthma Exacerbations

    Measured during the 36-week treatment period

  • Tests of Airway Caliber and Responsiveness (Forced Expiratory Volume in One Second (FEV1) Pre- and Post-bronchodilator Inhalation), Methacholine Provocative Concentration at 20% (PC20)

    Measured during the 36-week treatment period

  • Tests of Airway Inflammation (Exhaled Breath Condensate (EBC), Fractional Exhaled Nitric Oxide (FeNO), Sputum Eosinophils)

    Measured during the 36-week treatment period

  • +3 more secondary outcomes

Study Arms (3)

Symptom-based adjustment

EXPERIMENTAL

Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)

Behavioral: Symptom-based adjustment

Biomarker-based adjustment

EXPERIMENTAL

Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)

Behavioral: Biomarker-based adjustment

Guideline-based adjustment

EXPERIMENTAL

Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)

Behavioral: Guideline-based adjustment

Interventions

Symptom-based adjustmentBEHAVIORAL

Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)

Symptom-based adjustment
Biomarker-based adjustmentBEHAVIORAL

Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)

Biomarker-based adjustment
Guideline-based adjustmentBEHAVIORAL

Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)

Guideline-based adjustment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical history consistent with asthma
  • Forced expiratory volume in one second (FEV1) greater than 40% of predicted value
  • Asthma confirmed by one of the following two criteria:
  • Beta-agonist reversibility to 4 puffs albuterol of at least 12% OR
  • Methacholine provocative concentration at 20% (PC20) FEV1 of 8 milligrams per millimeter (mg/mL) or less when not on an inhaled corticosteroid, or 16 mg/mL or less when on an inhaled corticosteroid
  • Need for daily controller therapy (i.e., inhaled corticosteroids, leukotriene modifiers, and/or long-acting beta-agonists) based on one or more of the following criteria:
  • Received prescription for or used asthma controller within the 12 months prior to study entry OR
  • Experienced symptoms for more than twice a week and not on asthma controller
  • If on inhaled steroids (any drug at any dose not exceeding the equivalent of 1000 micrograms (mcg) of fluticasone daily), participant must have been on a stable dose for at least 2 weeks prior to study entry
  • Non-smoker (i.e., total lifetime smoking history less than 10 pack-years; no smoking for at least 1 year prior to study entry)
  • Willing to use an effective form of birth control throughout the study
  • Ability to measure peak expiratory flow (PEF) each morning using the electronic peak flow meter (EPFM) device and to accurately transcribe the PEF measurements onto the diary cards at least 75% of the time during the last 2 weeks of the adherence testing period
  • % compliance with recording peak flow measurements and symptoms in a symptom diary during the last 2 weeks of the adherence testing period
  • Ability to take Inhalers A, B, and C at least 75% of scheduled doses; 75% compliance per inhaler is required
  • No treatment failure (includes significant asthma exacerbation) within the last 4 weeks

You may not qualify if:

  • Lung disease other than asthma, including chronic obstructive pulmonary disease (COPD) and chronic bronchitis
  • Established or suspected diagnosis of vocal cord dysfunction
  • Significant medical illness other than asthma
  • History of respiratory tract infection within the 4 weeks prior to study entry
  • History of a significant exacerbation of asthma within the 4 weeks prior to study entry
  • History of life-threatening asthma requiring treatment with intubation and mechanical ventilation in the 5 years prior to study entry
  • Hyposensitization therapy other than an established maintenance regimen
  • Inability to coordinate use of the delivery devices used in the study, based on the opinion of the investigator or clinical coordinator
  • Pregnant
  • Inability to coordinate use of the medication delivery devices used in the study, based on the opinion of the investigator or clinical coordinator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of California, San Diego

San Diego, California, 92093, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Washington University, St. Louis

St Louis, Missouri, 63130, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

University of Wisconsin, Madison

Madison, Wisconsin, 53706, United States

Location

Related Publications (3)

  • Lugogo N, Green CL, Agada N, Zhang S, Meghdadpour S, Zhou R, Yang S, Anstrom KJ, Israel E, Martin R, Lemanske RF Jr, Boushey H, Lazarus SC, Wasserman SI, Castro M, Calhoun W, Peters SP, DiMango E, Chinchilli V, Kunselman S, King TS, Icitovic N, Kraft M. Obesity's effect on asthma extends to diagnostic criteria. J Allergy Clin Immunol. 2018 Mar;141(3):1096-1104. doi: 10.1016/j.jaci.2017.04.047. Epub 2017 Jun 15.

    PMID: 28624608DERIVED

  • Calhoun WJ, Ameredes BT, King TS, Icitovic N, Bleecker ER, Castro M, Cherniack RM, Chinchilli VM, Craig T, Denlinger L, DiMango EA, Engle LL, Fahy JV, Grant JA, Israel E, Jarjour N, Kazani SD, Kraft M, Kunselman SJ, Lazarus SC, Lemanske RF, Lugogo N, Martin RJ, Meyers DA, Moore WC, Pascual R, Peters SP, Ramsdell J, Sorkness CA, Sutherland ER, Szefler SJ, Wasserman SI, Walter MJ, Wechsler ME, Boushey HA; Asthma Clinical Research Network of the National Heart, Lung, and Blood Institute. Comparison of physician-, biomarker-, and symptom-based strategies for adjustment of inhaled corticosteroid therapy in adults with asthma: the BASALT randomized controlled trial. JAMA. 2012 Sep 12;308(10):987-97. doi: 10.1001/2012.jama.10893.

    PMID: 22968888DERIVED

  • Sutherland ER, Goleva E, Jackson LP, Stevens AD, Leung DY. Vitamin D levels, lung function, and steroid response in adult asthma. Am J Respir Crit Care Med. 2010 Apr 1;181(7):699-704. doi: 10.1164/rccm.200911-1710OC. Epub 2010 Jan 14.

    PMID: 20075384DERIVED

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Vernon M. Chinchilli, PhD
Organization
Penn State Hershey College of Medicine
vchinchi@psu.edu
717-531-4262

Study Officials

  • William J. Calhoun, MD

    University of Texas, Galveston

    PRINCIPAL INVESTIGATOR

  • Mario Castro, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Robert F. Lemanske, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

  • Richard J. Martin, MD

    National Jewish Health

    PRINCIPAL INVESTIGATOR

  • Elliot Israel, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

  • Stephen P. Peters, MD, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

  • Homer A. Boushey, MD

    University of California, San Francsico

    PRINCIPAL INVESTIGATOR

  • Stephen I. Wasserman, MD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

  • Emily DiMango, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Monica Kraft, MD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Reuben M. Cherniack, MD

    National Jewish Health

    STUDY CHAIR

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
Professor and Chair, Department of Public Health Sciences

Study Record Dates

First Submitted

June 28, 2007

First Posted

July 2, 2007

Study Start

June 1, 2007

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

April 11, 2013

Results First Posted

May 31, 2012

Record last verified: 2013-04

Locations

US(10)