Efficacy of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Overview

The purpose of this study is to further figure out differences of glycopyrronium bromide compared to tiotropium in early bronchodilation measured by a comprehensive assessment of lung function that includes hyperinflation and specific airway resistance in patients with moderate to severe COPD.

Full Title of Study: “A Randomized, Double-blind, Multicenter, 2-period Single-dose Cross-over Study to Assess the Early Bronchodilation of Glycopyrronium Bromide (44 μg o.d.) Compared to Tiotropium (18 µg. o.d.) in Patients With Moderate to Severe COPD (FAST Study)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2014

Interventions

  • Drug: NVA237
    • NVA237 44 µg inhalation capsules once daily, delivered via single-dose dry-powder inhaler (SDDPI)
  • Drug: Tiotropium
    • Tiotropium 18 μg once daily delivered via HandiHaler® device.
  • Drug: Placebo to NVA237
    • Placebo to NVA237 once daily, delivered via single-dose dry-powder inhaler (SDDPI).
  • Drug: Placebo to tiotropium
    • Placebo to tiotropium once daily delivered via HandiHaler® device
  • Drug: Salbutamol
    • Used as resuce medication

Arms, Groups and Cohorts

  • Experimental: NVA237 followed by tiotropium
    • Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication.
  • Experimental: Tiotropium followed by NVA237
    • Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication.

Clinical Trial Outcome Measures

Primary Measures

  • Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-2
    • Time Frame: Day 1
    • Standardized Forced Expiratory Volume in One Second (FEV1) AUC0-2h will be measured via spirometry. The AUC will be calculated from the FEV1 measurements obtained at timepoints between 0 min and 2h using the trapezoidal rule and will be standardized (=divided) by the measurement time (i.e. 2h).

Secondary Measures

  • Forced Expiratory Volume in One Second (FEV1) 15 Min Post Dose
    • Time Frame: Day 1
    • Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.
  • Specific Airway Resistance (sRAW)
    • Time Frame: Day 1
    • Specific Airway Resistance (sRAW) indicates volume and resistance-dependent work of breathing needed in order to generate a reference flow rate of 1 L/s, measured by kPa*s. Whole body plethysmography (Bodybox) is used to measure SRaw.
  • Functional Resistance Capacity (FRCpleth)
    • Time Frame: Day 1
    • Functional Resistance Capacity (FRCpleth) will be measured using whole body plethysmography (Bodybox).
  • Residual Volume (RV)
    • Time Frame: Day 1
    • Residual Volume (RV) will be measured using whole body plethysmography (Bodybox).
  • Total Lung Capacity (TLC)
    • Time Frame: Day 1
    • Total Lung Capacity (TLC) is the best vital capacity plus residual volume (RV). Whole body plethysmography (Bodybox) will be used to measure TLC.
  • Inspiratory Capacity (IC)
    • Time Frame: Day 1
    • Inspiratory Capacity (IC) is the volume of air breathed in by a maximum inspiration at the end of a normal expiration. Whole body plethysmography (Bodybox) will be used to measure IC.

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female adults aged ≥40 years
  • Patients with moderate to severe COPD defined by a post-bronchodilator Forced Expiratory Volume in One Second (FEV1)/(FVC) Forced Vital Capacity ratio of <0.70 and a post-bronchodilator FEV1 of ≤70% and FEV1 ≥ 30% of predicted normal values.
  • Current or ex-smokers who have a smoking history of at least 10 pack years.

Exclusion Criteria

  • Pregnant or nursing (lactating) women
  • Patients who have a clinically significant laboratory abnormality at run-in
  • Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment (GFR <50 ml/min/1,732) or urinary retention. (BPH patients who are stable on treatment can be considered).
  • Patients with any history of asthma
  • Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation
  • Patients receiving medications in the classes listed in the protocol as prohibited.

Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

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