Clinical Study Results
Improved bronchodilation with twice-daily SEEBRI NEOHALER
for people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
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:
- SEEBRI NEOHALER [prescribing information]. 2018.
- Data on file. GEM1 and GEM2 clinical study reports. Sunovion Pharmaceuticals Inc.
- Jones P, Quirk F, Baveystock C. The St George’s Respiratory Questionnaire. Respir Med. 1991;85(suppl B):25-31.