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Asthma Clinical Research Network (ACRN) Trial - Best Adjustment Strategy for Asthma in Long Term (BASALT) (BASALT)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Symptom-based adjustment
Biomarker-based adjustment
Guideline-based adjustment
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for BASALT and TALC Studies:

  • 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:

    1. Beta-agonist reversibility to 4 puffs albuterol of at least 12% OR
    2. 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:

    1. Received prescription for or used asthma controller within the 12 months prior to study entry OR
    2. 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

Inclusion Criteria for BASALT 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
  • 75% 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

Exclusion Criteria for BASALT and TALC Studies:

  • 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

Exclusion Criteria for BASALT Study:

  • Inability to coordinate use of the medication delivery devices used in the study, based on the opinion of the investigator or clinical coordinator

Sites / Locations

  • University of California, San Diego
  • University of California, San Francisco
  • National Jewish Medical and Research Center
  • Brigham & Women's Hospital
  • Washington University, St. Louis
  • Columbia University Medical Center
  • Duke University Medical Center
  • Wake Forest University Health Sciences
  • University of Texas Medical Branch
  • University of Wisconsin, Madison

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Symptom-based adjustment

Biomarker-based adjustment

Guideline-based adjustment

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Time to Treatment Failure (Measured in Days)

Secondary Outcome Measures

Number of Episodes of Treatment Failure
Time to First Asthma Exacerbation
Number of Asthma Exacerbations
Tests of Airway Caliber and Responsiveness (Forced Expiratory Volume in One Second (FEV1) Pre- and Post-bronchodilator Inhalation), Methacholine Provocative Concentration at 20% (PC20)
Tests of Airway Inflammation (Exhaled Breath Condensate (EBC), Fractional Exhaled Nitric Oxide (FeNO), Sputum Eosinophils)
Quality-of-life (AQLQ), Asthma Control Questionnaire (ACQ), and Number of Visit Days That ACQ is Less Than 1.25
Total Amount of Oral Prednisone Required and Total Amount of Inhaled Steroids
Adverse Events

Full Information

First Posted
June 28, 2007
Last Updated
April 5, 2013
Sponsor
Milton S. Hershey Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00495157
Brief Title
Asthma Clinical Research Network (ACRN) Trial - Best Adjustment Strategy for Asthma in Long Term (BASALT)
Acronym
BASALT
Official Title
Asthma Clinical Research Network (ACRN) Trial - Best Adjustment Strategy for Asthma in Long Term (BASALT)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Asthma is a common, long-term disease that is caused by inflammation of the airways. Symptoms of asthma may include wheezing, coughing, shortness of breath, and chest tightness. The most common treatment for asthma is the use of inhaled corticosteroid medications with periodic adjustments to treatment intensity. For example, corticosteroid dosage is increased when asthma symptoms worsen and decreased when symptoms improve. However, guidelines for making these adjustments, especially reduced intensity adjustments, have not been well established. In people who are initially well controlled on daily low-dose inhaled corticosteroid therapy, symptom-based adjustment (SBA) and/or biomarker-based adjustment (BBA) of inhaled corticosteroid therapy may be more beneficial at maintaining asthma control than standard, guideline-based adjustments (GBA). The purpose of this study is to determine if adjusting treatment based on symptoms and/or lung function biomarkers is more effective at controlling asthma than adjusting corticosteroid use based on standardized medical guidelines. This study begins with a 4-week period during which participants are monitored while they use an inhaler containing a low dose of inhaled corticosteroid medication. Participants then are assigned to take part in either the BASALT study or the Tiotropium as an Alternative to Long-Acting Beta-Agonists and Corticosteroids (TALC) study, which is a separate Asthma Clinical Research Network (ACRN) study. Participants in BASALT undergo 2 to 4 weeks of adherence testing, which involves using three inhalers that have electronic monitoring devices attached to them. Participants also are asked to measure and record their breathing rates and lung function in a study diary. BASALT participants are then randomly assigned to one of three treatment groups: SBA, BBA, or GBA. Each participant is given four inhalers: one inhaler contains albuterol, which is used on an as-needed basis as rescue medication; one inhaler contains corticosteroid medication; and two inhalers contain placebo. One of the latter three inhalers is used each time the albuterol inhaler is used, and the other two inhalers are used on a daily basis. Study visits occur at Weeks 2, 4, 6, 12, 18, 24, 30, and 36 of the treatment period. Inhalers are adjusted during these visits based on SBA, BBA, or GBA guidelines. At selected visits, the following procedures occur: physical exam; blood collection; allergy skin testing; heart rate monitoring; lung function and airway testing; methacholine challenge test to determine asthma severity; and questionnaires to assess asthma control, quality of life, and other healthcare factors. Participants record asthma symptoms, peak flow measurements, and medication usage in a daily diary.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
342 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Symptom-based adjustment
Arm Type
Experimental
Arm Description
Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Arm Title
Biomarker-based adjustment
Arm Type
Experimental
Arm Description
Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Arm Title
Guideline-based adjustment
Arm Type
Experimental
Arm Description
Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Intervention Type
Behavioral
Intervention Name(s)
Symptom-based adjustment
Intervention Description
Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Intervention Type
Behavioral
Intervention Name(s)
Biomarker-based adjustment
Intervention Description
Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Intervention Type
Behavioral
Intervention Name(s)
Guideline-based adjustment
Intervention Description
Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Primary Outcome Measure Information:
Title
Time to Treatment Failure (Measured in Days)
Time Frame
Measured during the 36-week treatment period
Secondary Outcome Measure Information:
Title
Number of Episodes of Treatment Failure
Time Frame
Measured during the 36-week treatment period
Title
Time to First Asthma Exacerbation
Time Frame
Measured during the 36-week treatment period
Title
Number of Asthma Exacerbations
Time Frame
Measured during the 36-week treatment period
Title
Tests of Airway Caliber and Responsiveness (Forced Expiratory Volume in One Second (FEV1) Pre- and Post-bronchodilator Inhalation), Methacholine Provocative Concentration at 20% (PC20)
Time Frame
Measured during the 36-week treatment period
Title
Tests of Airway Inflammation (Exhaled Breath Condensate (EBC), Fractional Exhaled Nitric Oxide (FeNO), Sputum Eosinophils)
Time Frame
Measured during the 36-week treatment period
Title
Quality-of-life (AQLQ), Asthma Control Questionnaire (ACQ), and Number of Visit Days That ACQ is Less Than 1.25
Time Frame
Measured during the 36-week treatment period
Title
Total Amount of Oral Prednisone Required and Total Amount of Inhaled Steroids
Time Frame
Measured during the 36-week treatment period
Title
Adverse Events
Time Frame
Measured during the 36-week treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for BASALT and TALC Studies: 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 Inclusion Criteria for BASALT 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 75% 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 Exclusion Criteria for BASALT and TALC Studies: 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 Exclusion Criteria for BASALT Study: Inability to coordinate use of the medication delivery devices used in the study, based on the opinion of the investigator or clinical coordinator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William J. Calhoun, MD
Organizational Affiliation
University of Texas, Galveston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mario Castro, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert F. Lemanske, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard J. Martin, MD
Organizational Affiliation
National Jewish Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elliot Israel, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen P. Peters, MD, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Homer A. Boushey, MD
Organizational Affiliation
University of California, San Francsico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen I. Wasserman, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emily DiMango, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Monica Kraft, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Reuben M. Cherniack, MD
Organizational Affiliation
National Jewish Health
Official's Role
Study Chair
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
National Jewish Medical and Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Washington University, St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
University of Wisconsin, Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28624608
Citation
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.
Results Reference
derived
PubMed Identifier
22968888
Citation
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.
Results Reference
derived
PubMed Identifier
20075384
Citation
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.
Results Reference
derived
Links:
URL
http://www.acrn.org
Description
Click here for the Asthma Clinical Research Network Web site

Learn more about this trial

Asthma Clinical Research Network (ACRN) Trial - Best Adjustment Strategy for Asthma in Long Term (BASALT)

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