Indacaterol provides sustained 24 h bronchodilation on once-daily dosing in asthma: a 7-day dose-ranging study.

Abstract

BACKGROUND:

Indacaterol is a novel, once-daily beta(2)-agonist in development for the treatment of asthma and chronic obstructive pulmonary disease. Studies were required to determine optimal dose(s) for continuing investigation.

OBJECTIVE:

A dose-ranging study was undertaken to evaluate efficacy and safety of indacaterol.

METHODS:

A total of 436 patients with persistent asthma receiving inhaled corticosteroids were randomized to 7 days treatment with once-daily indacaterol 50, 100, 200, or 400 microg via multi-dose dry-powder inhaler (MDDPI; Certihaler), indacaterol 400 microg via single-dose dry-powder inhaler (SDDPI), or placebo. Serial 24-h spirometry was performed on days 1 and 7. Vital signs, laboratory evaluations, and adverse events were monitored.

RESULTS:

All doses of indacaterol increased the mean time-standardized area under the curve of forced expiratory volume in 1 s (FEV(1)) from 22 to 24 h postdose (P <or= 0.001 vs placebo) on days 1 and 7, with clinically relevant treatment-placebo differences of 240, 260, 350, 300, and 380 ml on day 1 and 230, 220, 320, 250, and 270 ml on day 7 for indacaterol 50, 100, 200, and 400 microg via MDDPI and 400 microg via SDDPI, respectively. All doses increased mean FEV(1) (P < 0.05 vs placebo) from 5 min to 24 h postdose on days 1 and 7. All doses were well tolerated. Most adverse events were mild-to-moderate in severity: most frequently reported were respiratory, thoracic, and mediastinal disorders.

CONCLUSION:

Once-daily dosing with indacaterol provided sustained 24-h bronchodilation in patients with moderate-to-severe asthma, with a satisfactory overall safety profile. Indacaterol 200 microg appears the optimum dose, offering the best efficacy/safety balance.

• Authors: C LaForce, M Alexander, R Deckelmann, L M Fabbri, Z Aisanov, R Cameron, R Owen, M Higgins
• Journal: Allergy (Allergy) Vol. 63 Issue 1 Pg. 103-11 (Jan 2008) ISSN: 1398-9995 [Electronic] Denmark
• PMID: 18053019 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Indans
• Quinolones
• indacaterol

Topics

• Administration, Inhalation
• Adolescent
• Adult
• Aged
• Asthma (diagnosis, drug therapy)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Indans (administration & dosage)
• Male
• Metered Dose Inhalers
• Middle Aged
• Multivariate Analysis
• Probability
• Quinolones (administration & dosage)
• Reference Values
• Respiratory Function Tests
• Severity of Illness Index
• Spirometry
• Treatment Outcome