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Efficacy and safety of the long-acting β2-agonist olodaterol over 4 weeks in Japanese patients with chronic obstructive pulmonary disease.

Ichinose M, Takizawa A, Izumoto T, Tadayasu Y, Hamilton AL, Kunz C, Fukuchi Y - Int J Chron Obstruct Pulmon Dis (2015)

Bottom Line: A clear dose-response relationship was observed across all treatment groups.All doses of olodaterol were well tolerated, and no safety concerns were identified.QD olodaterol demonstrated 24-hour bronchodilator efficacy and was well tolerated in Japanese patients with COPD.

View Article: PubMed Central - PubMed

Affiliation: Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.

ABSTRACT

Background: Olodaterol is a novel long-acting β2-agonist with proven ≥24-hour duration of action in preclinical and clinical studies.

Objective: This randomized, double-blind, placebo-controlled, parallel-group study evaluated the dose response of once-daily (QD) olodaterol based on bronchodilator efficacy, safety, and pharmacokinetics over 4 weeks in Japanese patients with chronic obstructive pulmonary disease (COPD).

Methods: All eligible patients were randomized to receive 2 µg, 5 µg, or 10 µg of olodaterol or placebo for 4 weeks via the Respimat Soft Mist inhaler. The primary end point was the change from baseline in trough forced expiratory volume in 1 second (FEV1) after 4 weeks of olodaterol treatment. Secondary end points included trough FEV1 after 1 week and 2 weeks of treatment, FEV1 area under the curve from 0 hour to 3 hours (AUC(0-3)), peak FEV1 from 0 hour to 3 hours (peak FEV1), and corresponding forced vital capacity (FVC) responses. Rescue medication use, COPD symptoms, physician global evaluation, pharmacokinetics, and safety were also assessed.

Results: A total of 328 patients with COPD were randomized to receive treatment. All olodaterol doses assessed in the study showed statistically significant increases in trough FEV1 compared to placebo at Day 29 (P<0.0001). Mean increases in peak FEV1 and FEV1 AUC(0-3) compared to placebo were also significant (P<0.0001). A clear dose-response relationship was observed across all treatment groups. FVC responses (trough and FVC AUC(0-3)) supported FEV1 outcomes. All doses of olodaterol were well tolerated, and no safety concerns were identified.

Conclusion: QD olodaterol demonstrated 24-hour bronchodilator efficacy and was well tolerated in Japanese patients with COPD.

Trial registration: ClinicalTrials.gov: NCT00824382.

No MeSH data available.


Related in: MedlinePlus

Adjusted mean trough FEV1 (A) and FVC (B) responses (± standard error) at Weeks 1, 2, and 4 of olodaterol and placebo treatment.Abbreviations: FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity.
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f3-copd-10-1673: Adjusted mean trough FEV1 (A) and FVC (B) responses (± standard error) at Weeks 1, 2, and 4 of olodaterol and placebo treatment.Abbreviations: FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity.

Mentions: Statistically significant increases in trough FEV1 responses were demonstrated with all doses of olodaterol compared to placebo at Weeks 1 and 2 (P<0.005). A clear dose response was observed (Figure 3A), with dose ordering across the three doses of olodaterol. The responses for the 5 µg and 10 µg doses of olodaterol were significantly greater than 2 µg of olodaterol (P<0.05). No statistically significant differences in trough FEV1 responses between 5 µg and 10 µg of olodaterol were seen.


Efficacy and safety of the long-acting β2-agonist olodaterol over 4 weeks in Japanese patients with chronic obstructive pulmonary disease.

Ichinose M, Takizawa A, Izumoto T, Tadayasu Y, Hamilton AL, Kunz C, Fukuchi Y - Int J Chron Obstruct Pulmon Dis (2015)

Adjusted mean trough FEV1 (A) and FVC (B) responses (± standard error) at Weeks 1, 2, and 4 of olodaterol and placebo treatment.Abbreviations: FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4548739&req=5

f3-copd-10-1673: Adjusted mean trough FEV1 (A) and FVC (B) responses (± standard error) at Weeks 1, 2, and 4 of olodaterol and placebo treatment.Abbreviations: FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity.
Mentions: Statistically significant increases in trough FEV1 responses were demonstrated with all doses of olodaterol compared to placebo at Weeks 1 and 2 (P<0.005). A clear dose response was observed (Figure 3A), with dose ordering across the three doses of olodaterol. The responses for the 5 µg and 10 µg doses of olodaterol were significantly greater than 2 µg of olodaterol (P<0.05). No statistically significant differences in trough FEV1 responses between 5 µg and 10 µg of olodaterol were seen.

Bottom Line: A clear dose-response relationship was observed across all treatment groups.All doses of olodaterol were well tolerated, and no safety concerns were identified.QD olodaterol demonstrated 24-hour bronchodilator efficacy and was well tolerated in Japanese patients with COPD.

View Article: PubMed Central - PubMed

Affiliation: Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.

ABSTRACT

Background: Olodaterol is a novel long-acting β2-agonist with proven ≥24-hour duration of action in preclinical and clinical studies.

Objective: This randomized, double-blind, placebo-controlled, parallel-group study evaluated the dose response of once-daily (QD) olodaterol based on bronchodilator efficacy, safety, and pharmacokinetics over 4 weeks in Japanese patients with chronic obstructive pulmonary disease (COPD).

Methods: All eligible patients were randomized to receive 2 µg, 5 µg, or 10 µg of olodaterol or placebo for 4 weeks via the Respimat Soft Mist inhaler. The primary end point was the change from baseline in trough forced expiratory volume in 1 second (FEV1) after 4 weeks of olodaterol treatment. Secondary end points included trough FEV1 after 1 week and 2 weeks of treatment, FEV1 area under the curve from 0 hour to 3 hours (AUC(0-3)), peak FEV1 from 0 hour to 3 hours (peak FEV1), and corresponding forced vital capacity (FVC) responses. Rescue medication use, COPD symptoms, physician global evaluation, pharmacokinetics, and safety were also assessed.

Results: A total of 328 patients with COPD were randomized to receive treatment. All olodaterol doses assessed in the study showed statistically significant increases in trough FEV1 compared to placebo at Day 29 (P<0.0001). Mean increases in peak FEV1 and FEV1 AUC(0-3) compared to placebo were also significant (P<0.0001). A clear dose-response relationship was observed across all treatment groups. FVC responses (trough and FVC AUC(0-3)) supported FEV1 outcomes. All doses of olodaterol were well tolerated, and no safety concerns were identified.

Conclusion: QD olodaterol demonstrated 24-hour bronchodilator efficacy and was well tolerated in Japanese patients with COPD.

Trial registration: ClinicalTrials.gov: NCT00824382.

No MeSH data available.


Related in: MedlinePlus