AsthmaPhase 3BASALTNCT00495157
Asthma Clinical Research Network (ACRN) Trial - Best Adjustment Strategy for Asthma in Long Term (BASALT)
A Phase 3 study testing Symptom-based adjustment, Biomarker-based adjustment and Guideline-based adjustment in people with Asthma, run by Milton S. Hershey Medical Center at 10 sites in United States.
Trial summary
Asthma can be effectively controlled using inhaled corticosteroid medication. Treatment with inhaled corticosteroids often requires periodic adjustments to medication dosing and frequency levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Symptom-based adjustment, Biomarker-based adjustment and Guideline-based adjustment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 10 sitesUnited States
- Study dates
- Jun 2007to Jul 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 15Show fewer
- 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
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Brigham & Women's Hospital
Boston, Massachusetts, 02115
National Jewish Medical and Research Center
Denver, Colorado, 80206
Duke University Medical Center
Durham, North Carolina, 27710
University of Texas Medical Branch
Galveston, Texas, 77555
University of Wisconsin, Madison
Madison, Wisconsin, 53706
Columbia University Medical Center
New York, New York, 10032
University of California, San Diego
San Diego, California, 92093
University of California, San Francisco
San Francisco, California, 94143
Washington University, St. Louis
St Louis, Missouri, 63130
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Symptom-based adjustment, Biomarker-based adjustment, Guideline-based adjustment
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom-based adjustmentBehavioural
Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Biomarker-based adjustmentBehavioural
Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Guideline-based adjustmentBehavioural
Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
| Study group | Role | What they receive |
|---|---|---|
| Symptom-based adjustment | Experimental | Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg) Receives: 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) Receives: 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) Receives: Behavioral: Guideline-based adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Treatment Failure (Measured in Days)
Measured: Measured during the 36-week treatment period
Secondary outcomes (8)
Number of Episodes of Treatment Failure
Measured: Measured during the 36-week treatment period
Time to First Asthma Exacerbation
Measured: Measured during the 36-week treatment period
Number of Asthma Exacerbations
Measured: 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: Measured during the 36-week treatment period
Tests of Airway Inflammation (Exhaled Breath Condensate (EBC), Fractional Exhaled Nitric Oxide (FeNO), Sputum Eosinophils)
Measured: 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: Measured during the 36-week treatment period
Total Amount of Oral Prednisone Required and Total Amount of Inhaled Steroids
Measured: Measured during the 36-week treatment period
Adverse Events
Measured: Measured during the 36-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Vernon M. Chinchilli, PhD, Milton S. Hershey Medical Center
- Investigators
- William J. Calhoun, MD, Principal investigator, University of Texas, GalvestonMario Castro, MD, Principal investigator, Washington University School of MedicineRobert F. Lemanske, MD, Principal investigator, University of Wisconsin, MadisonRichard J. Martin, MD, Principal investigator, National Jewish HealthElliot Israel, MD, Principal investigator, Brigham and Women's HospitalStephen P. Peters, MD, PhD, Principal investigator, Wake Forest University Health SciencesHomer A. Boushey, MD, Principal investigator, University of California, San FrancsicoStephen I. Wasserman, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495157
- Sponsor's protocol ID
- 494
- Other IDs
- 5U10HL074231, U10HL074206, U10HL074208, U10HL074073, U10HL074227, U10HL074225, U10HL074204, U10HL074218
- Acronym
- BASALT
- Status last verified
- Apr 2013
- First submitted
- 28 Jun 2007
- Last updated
- 11 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 28624608Calhoun 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.
PubMed 22968888Sutherland 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.
PubMed 20075384
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Clinical Research Network (ACRN) Trial - Best Adjustment Strategy for Asthma in Long Term (BASALT)
- ClinicalTrials.gov ID
- NCT00495157
- Acronym / sponsor ID
- BASALT / 494
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 2 Jul 2007 (estimated)
- Results
- Posted 31 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Symptom-based adjustment | Experimental | Behavioral: Symptom-based adjustmentSymptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg) |
| Biomarker-based adjustment | Experimental | Behavioral: Biomarker-based adjustmentBiomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg) |
| Guideline-based adjustment | Experimental | Behavioral: Guideline-based adjustmentGuideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- 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:
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symptom-based adjustmentSymptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg) | Behavioural | Symptom-based adjustment |
| Biomarker-based adjustmentBiomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg) | Behavioural | Biomarker-based adjustment |
| Guideline-based adjustmentGuideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg) | Behavioural | Guideline-based adjustment |
Primary outcome
Time to Treatment Failure (Measured in Days)
Time frame: Measured during the 36-week treatment period
8 secondary outcomes
Number of Episodes of Treatment Failure
Time frame: Measured during the 36-week treatment period
Time to First Asthma Exacerbation
Time frame: Measured during the 36-week treatment period
Number of Asthma Exacerbations
Time frame: 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)
Time frame: Measured during the 36-week treatment period
Tests of Airway Inflammation (Exhaled Breath Condensate (EBC), Fractional Exhaled Nitric Oxide (FeNO), Sputum Eosinophils)
Time frame: 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
Time frame: Measured during the 36-week treatment period
Total Amount of Oral Prednisone Required and Total Amount of Inhaled Steroids
Time frame: Measured during the 36-week treatment period
Adverse Events
Time frame: Measured during the 36-week treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28624608Lugogo 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.
- Derived from this study: PubMed 22968888Calhoun 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.
- Derived from this study: PubMed 20075384Sutherland 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.
- Click here for the Asthma Clinical Research Network Web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William J. Calhoun, MD principal investigator
University of Texas, Galveston
Mario Castro, MD principal investigator
Washington University School of Medicine
Robert F. Lemanske, MD principal investigator
University of Wisconsin, Madison
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Symptom-based adjustment, Biomarker-based adjustment and Guideline-based adjustment in people with Asthma, run by Milton S. Hershey Medical Center at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Treatment Failure (Measured in Days) (time frame: Measured during the 36-week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00495157, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2013.