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TUDORZA for the long-term maintenance treatment of COPDEfficacy in COPD

Significant, sustained improvement inin lung function1-4 Sustained improvement in lung function was demonstrated in two 12-week and one 24-week efficacy and safety COPD clinical studies. TUDORZA PRESSAIR is not indicated for the initial treatment of acute episodes of bronchospasm (ie, rescue therapy).

 
12 Weeks, ACCORD COPD I and II Studies
12 and 24 Weeks, ATTAIN Study
 

Improved control—proven to increase lung function1-4

Significant improvement in lung function at 12 weeks1-3

In the ACCORD COPD I study:

Change in morning trough (predose) FEV1 at 12 weeks*2

TUDORZA PRESSAIR ACCORD COPD I Study Chart TUDORZA PRESSAIR ACCORD COPD I Study Chart
  • Statistically significant improvement in morning predose FEV1 was also demonstrated in the ACCORD COPD II study3
  • At 12 weeks, patients treated with TUDORZA 400 mcg achieved a 72-mL mean improvement in morning trough (predose) FEV1 over patients in the placebo group (P<0.01)*3

*Mean baseline FEV1 values were–in ACCORD COPD I: 1330 mL for the TUDORZA study group and 1380 mL for the placebo study group1,2; in ACCORD COPD II: 1250 mL for the TUDORZA study group and 1460 mL for the placebo study group.1,3

Use of rescue medication

Significantly reduced the frequency of daily rescue medication use over 12 weeks1,2,5

  • In a 12-week study (ACCORD COPD I), TUDORZA provided significant reduction in daily rescue albuterol use compared to placebo over the 12 weeks‡1,2,5
  • In another 12-week study (ACCORD COPD II), the reduction of daily rescue medication use for TUDORZA compared to placebo did not achieve statistical significance§1,3,5

The primary endpoint was the mean change from baseline in morning trough (predose) FEV1 at 12 weeks.1-3

ACCORD COPD I study–TUDORZA: -1.56 puffs/day, 35% reduction from baseline of 4.4 puffs/day; Placebo: -0.69 puffs/day, 18% reduction from baseline of 3.9 puffs/day (P<0.0001).5

§ACCORD COPD II study–TUDORZA: -1.44 puffs/day, 29% reduction from baseline of 4.9 puffs/day; Placebo: -1.13 puffs/day, 27% reduction from baseline of 4.2 puffs/day (P=not significant).5

STUDY DESIGNS

ACCORD COPD I and ACCORD COPD II: Two 12-week, randomized, double-blind, multicenter, placebo-controlled, parallel-group studies of 1105 patients with COPD compared aclidinium 400 µg BID and aclidinium 200 µg BID to placebo BID. The studies enrolled patients with a clinical diagnosis of COPD, were aged ≥40 years, were current or former smokers with a smoking history ≥10 pack-years, and had FEV1 30% to <80% predicted normal and a ratio of FEV1/FVC <0.7. The studies included a 2-week run-in period followed by a 12-week treatment period.1-3

Sustained effect—keeps patients breathing easier1-4

Significant improvement in lung function at 12 and 24 weeks1,4

Sustained improvement in lung function was demonstrated in two 12-week and one 24-week efficacy and safety COPD clinical studies.

In the ATTAIN study:

Change in morning trough (predose) FEV1 at 12 and 24 weeks*4

TUDORZA PRESSAIR ATTAIN Study Chart
TUDORZA PRESSAIR ATTAIN Study Chart

*Mean baseline FEV1 values were–in ATTAIN: 1510 mL for the TUDORZA study group and 1500 mL for the placebo study group.1,4

Use of rescue medication

Significantly reduced the frequency of daily rescue medication use over 12 and 24 weeks1,4,5

  • In the ATTAIN study, TUDORZA provided significant reductions in daily rescue albuterol use compared to placebo over 12 and 24 weeks§1,4,5

The primary endpoint was the mean change from baseline in morning trough (predose) FEV1 at 12 weeks.1,4

§ATTAIN study–Over 12 weeks, TUDORZA: -1.26 puffs/day, 36% reduction from baseline of 3.5 puffs/day; Placebo: -0.27 puffs/day, 7% reduction from baseline of 3.8 puffs/day (P=0.003). Over 24 weeks, TUDORZA: -1.20 puffs/day, 34% reduction from baseline of 3.5 puffs/day; Placebo: -0.25 puffs/day, 7% reduction in baseline of 3.8 puffs/day (P=0.0045).5

STUDY DESIGN

ATTAIN: A 24-week, randomized, double-blind, multicenter, placebo-controlled, parallel-group study of 828 patients with COPD compared aclidinium 400 µg BID and aclidinium 200 µg BID to placebo BID. The studies enrolled patients with a clinical diagnosis of COPD, were aged ≥40 years, current or former smokers with a smoking history ≥10 pack-years, a FEV1 of 30% to <80% of predicted normal, and a ratio of FEV1/FVC of <0.7. The study included a 2-week run-in period followed by a 24-week treatment period.1,4

IMPORTANT SAFETY INFORMATION

  • TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is contraindicated in patients with severe hypersensitivity to milk proteins or who have hypersensitivity to aclidinium bromide or any of the excipients
  • TUDORZA PRESSAIR is not indicated for the initial treatment of acute episodes of bronchospasm (ie, rescue therapy)
  • Immediate hypersensitivity reactions, including anaphylaxis, angioedema (swelling of lips, tongue, or throat), urticaria, rash, bronchospasm, or itching have occurred after administration of TUDORZA PRESSAIR. Additionally, inhaled medicines, including TUDORZA PRESSAIR, may cause paradoxical bronchospasm. If any of these occurs, treatment with TUDORZA PRESSAIR should be stopped and other treatments considered
  • TUDORZA PRESSAIR should be used with caution in patients with narrow-angle glaucoma or urinary retention. Instruct patients to consult a physician immediately should any signs or symptoms of acute narrow-angle glaucoma or prostatic hyperplasia or bladder-neck obstruction develop
  • The most common adverse reactions (≥3% incidence and greater than placebo) were headache (6.6% vs 5.0%), nasopharyngitis (5.5% vs 3.9%), and cough (3.0% vs 2.2%), for TUDORZA PRESSAIR vs placebo, respectively

INDICATIONS AND USAGE

TUDORZA PRESSAIR is an anticholinergic indicated for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Please also see the full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
  
 
 
 

References:

  • Prescribing Information for TUDORZA PRESSAIR. AstraZeneca Pharmaceuticals LP, Wilmington, DE.
  • Kerwin EM, D’Urzo AD, Gelb AF, et al; on behalf of the ACCORD I study investigators. Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD. 2012;9:90-101.
  • Rennard SI, Scanlon PD, Ferguson GT, et al. ACCORD COPD II: a randomized clinical trial to evaluate the 12-week efficacy and safety of twice-daily aclidinium bromide in chronic obstructive pulmonary disease patients. Clin Drug Investig. 2013;33:893-904.
  • Jones PW, Singh D, Bateman ED, et al. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. Eur Respir J. 2012;40:830-836.
  • Data on File, 3122905, AZPLP.