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Completed

NCT Number: NCT01922271

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Leipzig, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NVA237

Drug

NVA237 44 µg inhalation capsules once daily, delivered via single-dose dry-powder inhaler (SDDPI)

Tiotropium

Drug

Tiotropium 18 μg once daily delivered via HandiHaler® device.

Placebo to NVA237

Drug

Placebo to NVA237 once daily, delivered via single-dose dry-powder inhaler (SDDPI).

Placebo to tiotropium

Drug

Placebo to tiotropium once daily delivered via HandiHaler® device

Salbutamol

Drug

Used as resuce medication

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. Functional Resistance Capacity (FRCpleth)

    Time frame: Day 1

    Functional Resistance Capacity (FRCpleth) will be measured using whole body plethysmography (Bodybox).

  4. Residual Volume (RV)

    Time frame: Day 1

    Residual Volume (RV) will be measured using whole body plethysmography (Bodybox).

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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)

Acronym: FAST

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 14, 2013
Registry last updated
Jan 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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