Efficacy of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD) (FAST)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
NVA237
Tiotropium
Placebo to NVA237
Placebo to tiotropium
Salbutamol
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD
Eligibility Criteria
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
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
NVA237 followed by tiotropium
Tiotropium followed by NVA237
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-2
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 Outcome Measures
Forced Expiratory Volume in One Second (FEV1) 15 Min Post Dose
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)
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)
Functional Resistance Capacity (FRCpleth) will be measured using whole body plethysmography (Bodybox).
Residual Volume (RV)
Residual Volume (RV) will be measured using whole body plethysmography (Bodybox).
Total Lung Capacity (TLC)
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)
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.
Full Information
NCT ID
NCT01922271
First Posted
August 9, 2013
Last Updated
December 19, 2014
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01922271
Brief Title
Efficacy of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Acronym
FAST
Official 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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NVA237 followed by tiotropium
Arm Type
Experimental
Arm Description
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.
Arm Title
Tiotropium followed by NVA237
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
NVA237
Intervention Description
NVA237 44 µg inhalation capsules once daily, delivered via single-dose dry-powder inhaler (SDDPI)
Intervention Type
Drug
Intervention Name(s)
Tiotropium
Intervention Description
Tiotropium 18 μg once daily delivered via HandiHaler® device.
Intervention Type
Drug
Intervention Name(s)
Placebo to NVA237
Intervention Description
Placebo to NVA237 once daily, delivered via single-dose dry-powder inhaler (SDDPI).
Intervention Type
Drug
Intervention Name(s)
Placebo to tiotropium
Intervention Description
Placebo to tiotropium once daily delivered via HandiHaler® device
Intervention Type
Drug
Intervention Name(s)
Salbutamol
Intervention Description
Used as resuce medication
Primary Outcome Measure Information:
Title
Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-2
Description
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).
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Forced Expiratory Volume in One Second (FEV1) 15 Min Post Dose
Description
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.
Time Frame
Day 1
Title
Specific Airway Resistance (sRAW)
Description
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.
Time Frame
Day 1
Title
Functional Resistance Capacity (FRCpleth)
Description
Functional Resistance Capacity (FRCpleth) will be measured using whole body plethysmography (Bodybox).
Time Frame
Day 1
Title
Residual Volume (RV)
Description
Residual Volume (RV) will be measured using whole body plethysmography (Bodybox).
Time Frame
Day 1
Title
Total Lung Capacity (TLC)
Description
Total Lung Capacity (TLC) is the best vital capacity plus residual volume (RV). Whole body plethysmography (Bodybox) will be used to measure TLC.
Time Frame
Day 1
Title
Inspiratory Capacity (IC)
Description
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.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12043
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12687
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13086
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Novartis Investigative Site
City
Gelsenkirchen
ZIP/Postal Code
45879
Country
Germany
Facility Name
Novartis Investigative Site
City
Grosshansdorf
ZIP/Postal Code
22947
Country
Germany
Facility Name
Novartis Investigative Site
City
Gummersbach
ZIP/Postal Code
51643
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Novartis Investigative Site
City
Kassel
ZIP/Postal Code
34121
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04207
Country
Germany
Facility Name
Novartis Investigative Site
City
Lübeck
ZIP/Postal Code
23552
Country
Germany
Facility Name
Novartis Investigative Site
City
Rüdersdorf
ZIP/Postal Code
15562
Country
Germany
Facility Name
Novartis Investigative Site
City
Sonneberg
ZIP/Postal Code
96515
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
27940287
Citation
Watz H, Mailander C, May C, Baier M, Kirsten AM. Fast onset of action of glycopyrronium compared with tiotropium in patients with moderate to severe COPD - A randomised, multicentre, crossover trial. Pulm Pharmacol Ther. 2017 Feb;42:13-20. doi: 10.1016/j.pupt.2016.12.001. Epub 2016 Dec 9.
Results Reference
derived
Learn more about this trial
Efficacy of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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