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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00495157

Acronym

BASALT

Enrollment

342

Registered

2007-07-02

Start date

2007-06-30

Completion date

2010-07-31

Last updated

2013-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

BEHAVIORALSymptom-based adjustment

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

BEHAVIORALBiomarker-based adjustment

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

BEHAVIORALGuideline-based adjustment

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Time to Treatment Failure (Measured in Days)	Measured during the 36-week treatment period

Secondary

Measure	Time frame
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
Number of Episodes of Treatment Failure	Measured during the 36-week treatment period
Quality-of-life (AQLQ), Asthma Control Questionnaire (ACQ), and Number of Visit Days That ACQ is Less Than 1.25	Measured during the 36-week treatment period
Total Amount of Oral Prednisone Required and Total Amount of Inhaled Steroids	Measured during the 36-week treatment period
Adverse Events	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

Countries

United States

Participant flow

Participants by arm

Arm	Count
Symptom-based Adjustment Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)	113
Biomarker-based Adjustment Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)	115
Guideline-based Adjustment Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)	114
Total	342

Baseline characteristics

Characteristic	Biomarker-based Adjustment	Guideline-based Adjustment	Symptom-based Adjustment	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	1 Participants	2 Participants	2 Participants	5 Participants
Age, Categorical Between 18 and 65 years	114 Participants	112 Participants	111 Participants	337 Participants
Age Continuous	34.8 years STANDARD_DEVIATION 11.3	34.2 years STANDARD_DEVIATION 11.9	36.0 years STANDARD_DEVIATION 12.2	35.0 years STANDARD_DEVIATION 11.8
Region of Enrollment United States	115 participants	114 participants	113 participants	342 participants
Sex: Female, Male Female	82 Participants	72 Participants	83 Participants	237 Participants
Sex: Female, Male Male	33 Participants	42 Participants	30 Participants	105 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	2 / 113	7 / 115	8 / 114
serious Total, serious adverse events	6 / 113	0 / 115	1 / 114