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A Randomized Pragmatic Trial of Changing to and Stepping Down Fluticasone/Formoterol in Asthma
- Source :
- 1387.e5
- Publication Year :
- 2016
-
Abstract
- Background Guidelines recommend reducing treatment in patients with well-controlled asthma after 3 months of stability. However, there is inadequate real-life data to guide physicians on therapy change in daily practice. Objective To assess asthma control after change to and step-down of fluticasone propionate/formoterol fumarate dihydrate (FP/FOR) in real-life patients. Methods In a randomized controlled, pragmatic, open-label trial, 225 well-controlled patients with asthma were randomized (1:2) to maintain high-dose fluticasone propionate/salmeterol xinafoate (FP/SAL, 1000/100 μg) or switch to FP/FOR (1000/40 μg) daily for 12 weeks (phase 1). One hundred sixteen patients stable on FP/FOR at week 12 were subsequently randomized (1:1) to maintain this therapy, or stepped down to FP/FOR (500/20 μg) daily for 12 weeks (phase 2). The primary end point was the 7-question Asthma Control Questionnaire (ACQ7) score. Results In phase 1, FP/FOR (1000/40 μg) (n = 126) was noninferior to FP/SAL (1000/100 μg) (n = 73) for ACQ7 (difference in means, −0.12; 95% CI, −0.32 to 0.09). In phase 2, FP/FOR (500/20 μg) (n = 52) was noninferior to FP/FOR (1000/40 μg) (n = 52) for ACQ7 (difference in means, 0.01; 95% CI, −0.20 to 0.22). There was no significant difference in exacerbation rate between the groups in either phase. However, 1 to 2 exacerbations in 12 months before phase 1 were associated with the occurrence of an exacerbation after step-down ( P = .007). Conclusions In patients with well-controlled asthma, a change from FP/SAL to FP/FOR did not compromise asthma control. Step-down of FP/FOR was well tolerated; however, in contrast to current guidelines, our data suggest caution in stepping down patients uncontrolled in the last 12 months. Larger step-down studies are required to confirm these findings.
- Subjects :
- PNEUMONIA
Male
ACQ7
Exacerbation
Allergy
Antiasthmatic agents
0302 clinical medicine
MARKERS
Clinical Protocols
Asthma control
Formoterol Fumarate
Surveys and Questionnaires
Clinical endpoint
Immunology and Allergy
Medicine
030212 general & internal medicine
Formoterol
Salmeterol
Salmeterol Xinafoate
Pragmatic trials
RISK
Inhaled corticosteroids
INHALED CORTICOSTEROID-THERAPY
Middle Aged
Pragmatic trial
Bronchodilator Agents
Drug Combinations
Treatment Outcome
Step-down
Asthma Control Questionnaire
Anesthesia
Practice Guidelines as Topic
Female
Life Sciences & Biomedicine
medicine.drug
EXHALED NITRIC-OXIDE
Adult
medicine.medical_specialty
Immunology
QUESTIONNAIRE
Fluticasone propionate
VALIDATION
03 medical and health sciences
Internal medicine
Humans
Combination therapy
METAANALYSIS
Asthma
Aged
Science & Technology
business.industry
Fractional exhaled nitric oxide
medicine.disease
030228 respiratory system
Withholding Treatment
EXACERBATION
Fluticasone
Fluticasone-formoterol
business
Biomarkers
Subjects
Details
- ISSN :
- 22132201
- Volume :
- 5
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- The journal of allergy and clinical immunology. In practice
- Accession number :
- edsair.doi.dedup.....739f743f807afafa3261ab5ca05b2550