Phase 4
Completed N=455
Long-acting Beta Agonist Step Down Study
Source: ClinicalTrials.gov NCT01437995 ↗Enrolled (actual)
455
Serious AEs
5.5%
Results posted
Apr 2017
Primary outcomePrimary: Treatment Failure — 38; 39; 45 participants
◆ Published Evidence
Established
70citations · ~9 / year
Risk Factors for Asthma Exacerbation and Treatment Failure in Adults and Adolescents with Well-controlled Asthma during Continuation and Step-Down Therapy.
Summary
This study is a 56-week, multi-center, blinded, randomized, double-masked parallel group comparative effectiveness study of approaches to stepping down therapy for patients with well-controlled asthma treated with combination ICS and LABA.
Linked Publications (2)
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Risk Factors for Asthma Exacerbation and Treatment Failure in Adults and Adolescents with Well-controlled Asthma during Continuation and Step-Down Therapy.
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Comprehension by Caregivers and Adolescents of Clinical Trial Information Delivered via Multimedia Video Versus Conventional Practice: Nonrandomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Failure |
38; 39; 45 | — |
| SECONDARY Pulmonary Function- Change in Peak Expiratory Flow |
-0.08; 4.40; -14.16 | 0.43 |
| SECONDARY Rate of Episodes of Poor Asthma Control |
183; 164; 219 | — |
| SECONDARY Change in Pulmonary Function: FEV1 and FVC |
-0.02; -0.07; -0.13; -0.01; -0.04; -0.09 | 0.15 |
| SECONDARY Pulmonary Function: Change in FEV1/FVC Ratio |
-0.002; -0.009; -0.02 | 0.14 |
Eligibility Criteria
Inclusion Criteria
- age 12-80 years
- physician diagnosed asthma that is well-controlled on moderate dose ICS/LABA based on an Asthma Control Test (ACT) score more than or equal to 20, and the absence of unscheduled visits or use of rescue prednisone for 4 weeks prior to enrollment
- pre-bronchodilator FEV1 (forced expiratory volume in 1 second) more than or equal to 70% predicted
Exclusion Criteria
- chronic oral steroid therapy
- hospitalization or urgent care visit within 4 weeks of the screening visit
- lung disease other than asthma including COPD, bronchiectasis, sarcoidosis or other lung disease
- less than 10 pack/yr of tobacco use and abstinence for at least 1 yr
- history of extensive environmental tobacco exposure or occupational exposure suggestive of possible COPD (chronic obstructive pulmonary disease) per judgment of investigator
- post bronchodilator FEV1 less than 70% predicted
- near fatal asthma (intubation or ICU admission for asthma) within 2 yrs of enrollment
- high risk of near fatal or fatal asthma
- history of known premature birth less than 33 weeks or any significant level of respiratory care including prolonged oxygen administration or mechanical ventilation during the neonatal period
- unstable cardiac disease (decompensated congestive heart failure, unstable angina, recent myocardial infarction, atrial fibrillation, supraventricular or ventricular tachycardia, congenital heart disease, or severe uncontrolled hypertension)
- other major chronic illnesses which in the judgment of the study physician would interfere with participation in the study e.g. including but not limited to uncontrolled diabetes, uncontrolled HIV infection or other immune system disorder
- drug allergies to any component of study drug or history of adverse reaction to short or long acting beta agonists
- for women of child bearing potential; not pregnant, not lactating and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study
Data sourced from ClinicalTrials.gov (NCT01437995) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.