Abstract | OBJECTIVE: METHODS: A 3-month, double-blind, placebo-controlled clinical trial (n=123), followed by a 9-month open-label phase (n=120). The study was conducted at 26 medical centers in the United States. Patients were randomized to treatment with MF-MDI 400 or 800 microg twice-daily (bid) doses, or placebo in the double-blind trial. All patients received MF in the open-label phase. RESULTS: At the endpoint of the double-blind trial, MF-MDI 400 and 800 microg bid reduced the daily OCS dose by 39.4% and 31.1%, respectively, while placebo increased the OCS dose by 107.2% (P<0.01). The OCS requirement was reduced by 50% or more in 63% and 60% of patients treated with MF-MDI 400 and 800 microg bid, respectively, compared with 14% of patients receiving placebo. After 12 weeks, despite prednisone reductions, pulmonary function, asthma symptoms, albuterol use, nocturnal awakenings, and physician-evaluated response to therapy also showed significant improvement with MF-MDI treatment compared with placebo. Further reductions in OCS requirements were achieved with long-term MF-MDI treatment in the open-label phase, with an overall 67% reduction in prednisone usage and 51% of patients completely eliminating prednisone usage by the 1-year time point. CONCLUSION: MF delivered by HFA-227 MDI significantly reduces daily OCS use compared with placebo and facilitates elimination of OCS use in patients with severe persistent asthma.
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Authors | Jill P Karpel, Anjuli Nayak, William Lumry, Timothy J Craig, Edward Kerwin, James E Fish, Barry Lutsky |
Journal | Respiratory medicine
(Respir Med)
Vol. 101
Issue 3
Pg. 628-37
(Mar 2007)
ISSN: 0954-6111 [Print] England |
PMID | 16875813
(Publication Type: Journal Article, Randomized Controlled Trial)
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Chemical References |
- Anti-Inflammatory Agents
- Glucocorticoids
- Pregnadienediols
- Mometasone Furoate
- Prednisone
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Topics |
- Administration, Inhalation
- Administration, Oral
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Anti-Inflammatory Agents
(administration & dosage, adverse effects)
- Asthma
(drug therapy, physiopathology)
- Double-Blind Method
- Drug Administration Schedule
- Drug Therapy, Combination
- Female
- Glucocorticoids
(administration & dosage)
- Humans
- Lung
(drug effects, physiopathology)
- Male
- Metered Dose Inhalers
- Middle Aged
- Mometasone Furoate
- Prednisone
(administration & dosage)
- Pregnadienediols
(administration & dosage, adverse effects)
- Quality of Life
- Treatment Outcome
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