Clinical Study Results

Improved bronchodilation with twice-daily SEEBRI NEOHALER

for people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema

Study description

The efficacy and safety of SEEBRI NEOHALER were established in two 12-week, multicenter, randomized, double-blind, parallel-group, placebo-controlled trials of 867 patients. The primary end point was change in FEV1 AUC0-12hr following morning dose at Day 85 from baseline vs placebo. Secondary end points included change in St. George's Respiratory Questionnaire total score, rescue medication use, trough FEV1, and peak FEV1 vs placebo at Week 12. The safety of SEEBRI NEOHALER was established in four 12-week lung-function trials of 2908 patients and one 52-week, long-term study of 507 patients.1,2

Lung function

Improvement in lung function with SEEBRI NEOHALER

>120 mL improvement in FEV1 AUC0-12hr vs placebo at Week 12 in 2 trials1,2

 

SEEBRI NEOHALER is contraindicated in patients with a hypersensitivity to glycopyrrolate or to any of the ingredients.

 

 

SEEBRI NEOHALER improved FEV1 over 12 hours1,2

Improvements in FEV1 over 12 hours at Week 12 in Trial 11,†

AUC=area under the curve; FEV1=forced expiratory volume in 1 second; LS=least squares.

Sustained bronchodilation all day and night with twice-daily SEEBRI NEOHALER1

Improvements in trough FEV1 with SEEBRI NEOHALER

 

  • Trough FEV1 is the mean of FEV1 at 23 hr 15 min and 23 hr 45 min after the morning dose2
  • Clinically important difference in trough FEV1 is defined as ≥100 mL improvement vs placebo3
  • Patients treated with SEEBRI NEOHALER maintained FEV1 improvements of ≥100 mL over the full 12-week treatment period in Trial 12

SEEBRI NEOHALER should not be initiated in patients with acutely deteriorating or potentially life-threatening episodes of COPD or used as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.

Peak FEV1 improvement on Day 1 maintained at Week 12

>135 mL improvement vs placebo at Day 1 and Week 12 in 2 trials1,2

 

 

  • The peak FEV1 was defined as the maximum FEV1 recorded within 4 hours after the morning dose on Day 1 and Week 121
  • Improvement on Day 1 and Week 12 with SEEBRI NEOHALER (n=222) vs placebo (n=216) in Trial 11
  • Improvement on Day 1 and Week 12 with SEEBRI NEOHALER (n=215) vs placebo (n=213) in Trial 21

AUC=area under the curve; FEV1=forced expiratory volume in 1 second; LS=least squares.

Reduced rescue medication use over 24 hours with twice-daily SEEBRI NEOHALER

Greater reduction in daily rescue medication use vs placebo in 2 trials2*
 

 

  • SEEBRI NEOHALER is not a rescue inhaler and is not indicated to treat episodes of acute bronchospasm1
  • The mean daily number of puffs of rescue medication at baseline was [Trial 1: SEEBRI NEOHALER, 4.67; placebo, 4.79] [Trial 2: SEEBRI NEOHALER, 4.55; placebo, 3.94]2

*The total number of puffs of rescue medication per day over the whole active treatment period was calculated and divided by the total number of days with nonmissing rescue data to derive the mean daily number of puffs of rescue medication take for the patient.

AUC=area under the curve; FEV1=forced expiratory volume in 1 second; LS=least squares.

St. George’s Respiratory Questionnaire (SGRQ) measures the impact of COPD on quality of life. 

The SGRQ is a patient-reported measurement that evaluates 3 subcomponents that produce a total score: physical activity, social engagement, and symptom improvement. Improvement in SGRQ is based on the total score and not on the individual subcomponents.3

Immediate hypersensitivity reactions have been reported with SEEBRI NEOHALER. If signs occur, discontinue immediately and institute alternative therapy. SEEBRI NEOHALER should be used with caution in patients with severe hypersensitivity to milk proteins.

Clinically meaningful improvement in health-related quality of life as measured by SGRQ total score1

 

  • Meaningful improvement is defined as a ≥4-point decrease in SGRQ total score1
  • Meaningful improvement in SGRQ score reported by 49% of patients taking SEEBRI NEOHALER vs 41% with placebo in Trial 1 (odds ratio of 1.43 [95% CI: 0.95, 2.15]) and 55% of patients taking SEEBRI NEOHALER vs 42% with placebo in Trial 2 (odds ratio of 1.78 [95% CI: 1.17, 2.71])1

SEEBRI NEOHALER Adverse Reactions

Proven safety profile established in 3415 COPD patients across 5 trials (four 12-week and one 52-week)1

Adverse reactions reported in four 12-week trials ≥1% incidence and higher than placebo1

 

  • Fewer patients (2.4%) discontinued treatment due to AEs with SEEBRI NEOHALER vs placebo (3.8%) in four 12-week trials1
  • Adverse reactions reported in the long-term 52-week trial were consistent with those observed in the placebo-controlled trials of 12 weeks1
    • Additional adverse reactions ≥2% with SEEBRI NEOHALER and greater than indacaterol 75 mcg once-daily in this trial were diarrhea, nausea, upper abdominal pain, fatigue, bronchitis, pneumonia, rhinitis, back pain, arthralgia, dyspnea, and wheezing


 

References:

  1. SEEBRI NEOHALER [prescribing information]. 2018.
  2. Data on file. GEM1 and GEM2 clinical study reports. Sunovion Pharmaceuticals Inc.
  3. Jones P, Quirk F, Baveystock C. The St George’s Respiratory Questionnaire. Respir Med. 1991;85(suppl B):25-31.

Important Safety Information & Indication 

Important Safety Information

SEEBRI NEOHALER is contraindicated in patients with a hypersensitivity to glycopyrrolate or to any of the ingredients.

SEEBRI NEOHALER should not be initiated in patients with acutely deteriorating or potentially life-threatening episodes of COPD or used as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.

As with other inhaled medicines, SEEBRI NEOHALER can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs following dosing with SEEBRI NEOHALER, it should be treated immediately with an inhaled, short-acting bronchodilator; SEEBRI NEOHALER should be discontinued immediately and alternative therapy instituted.

Immediate hypersensitivity reactions have been reported with SEEBRI NEOHALER. If signs occur, discontinue immediately and institute alternative therapy. SEEBRI NEOHALER should be used with caution in patients with severe hypersensitivity to milk proteins.

SEEBRI NEOHALER should be used with caution in patients with narrow-angle glaucoma and in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema) and of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Patients should be instructed to consult a physician immediately should any of these signs or symptoms develop.

The most common adverse events reported in ≥1% of patients taking SEEBRI NEOHALER, and occurring more frequently than in patients taking placebo, were upper respiratory tract infection (3.4% vs 2.3%), nasopharyngitis (2.1% vs 1.9%), oropharyngeal pain (1.8% vs 1.2%), urinary tract infection (1.4% vs 1.3%), and sinusitis (1.4% vs 0.7%).

SEEBRI capsules must not be swallowed as the intended effects on the lungs will not be obtained. SEEBRI capsules are only for oral inhalation and should only be used with the NEOHALER device.

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.

For additional information, please see full Prescribing Information and Patient Information for SEEBRI NEOHALER.


Indication

SEEBRI® NEOHALER® (glycopyrrolate) is an anticholinergic indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.