Effect of NVA237 on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (COPD) (GLOW3)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01154127

First received: June 29, 2010

Last updated: April 10, 2012

Last verified: April 2012

History of Changes

Results First Received: February 8, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Chronic Obstructive Pulmonary Disease
Interventions:	Drug: NVA237 Drug: Placebo

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
NVA237 Followed by Placebo	Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days. Period 2: Matching placebo via NEOHALER inhaler device for 21 days The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. Salbutamol (albuterol) was used as rescue medication throughout the study.
Placebo Followed by NVA237	Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days Period 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days. The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. Salbutamol (albuterol) was used as rescue medication throughout the study.

Description

NVA237 Followed by Placebo

Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days.

Period 2: Matching placebo via NEOHALER inhaler device for 21 days

The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.

Salbutamol (albuterol) was used as rescue medication throughout the study.

Placebo Followed by NVA237

Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days

Period 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days.

The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.

Salbutamol (albuterol) was used as rescue medication throughout the study.

Participant Flow for 3 periods

Period 1: Period 1 (21 Days)

	NVA237 Followed by Placebo	Placebo Followed by NVA237
STARTED	55	53
COMPLETED	52	47
NOT COMPLETED	3	6
Adverse Event	3	4
Withdrawal by Subject	0	2

Period 2: Washout (14 - 28 Days)

	NVA237 Followed by Placebo	Placebo Followed by NVA237
STARTED	52	47
COMPLETED	49	47
NOT COMPLETED	3	0
Adverse Event	2	0
Abnormal Test Procedure	1	0

Period 3: Period 2 (21 Days)

	NVA237 Followed by Placebo	Placebo Followed by NVA237
STARTED	49	47
COMPLETED	49	46
NOT COMPLETED	0	1
Protocol Deviation	0	1

Baseline Characteristics

Show Baseline Characteristics

Outcome Measures

Show All Outcome Measures

1. Primary:

Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks (Day 21) of Treatment [ Time Frame: Day 21 ]

Show Outcome Measure 1

2. Secondary:

Isotime Inspiratory Capacity (IC) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment [ Time Frame: Day 21 ]

Show Outcome Measure 2

3. Secondary:

Inspiratory Capacity (IC) at Rest (1 Hour Post Dose) and at Peak (End of Exercise) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment [ Time Frame: Day 21 ]

Show Outcome Measure 3

4. Secondary:

Peak and Trough (24 h Post Dose) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) [ Time Frame: Day 21 ]

Show Outcome Measure 4

5. Secondary:

Slow Vital Capacity (SVC) and Total Lung Capacity (TLC) [ Time Frame: Day 21 ]

Show Outcome Measure 5

6. Secondary:

Specific Airways Conductance (SGaw) [ Time Frame: Day 21 ]

Show Outcome Measure 6

7. Secondary:

Exertional Dyspnea (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment [ Time Frame: Day 21 ]

Show Outcome Measure 7

8. Secondary:

Leg Discomfort (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment [ Time Frame: Day 21 ]

Show Outcome Measure 8

9. Secondary:

Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) on Treatment Day 1 [ Time Frame: Day 1 ]

Show Outcome Measure 9

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided by Novartis

Publications automatically indexed to this study:

Beeh KM, Singh D, Di Scala L, Drollmann A. Once-daily NVA237 improves exercise tolerance from the first dose in patients with COPD: the GLOW3 trial. Int J Chron Obstruct Pulmon Dis. 2012;7:503-13. doi: 10.2147/COPD.S32451. Epub 2012 Jul 31.

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01154127 History of Changes
Other Study ID Numbers:	CNVA237A2310, 2010-018597-20
Study First Received:	June 29, 2010
Results First Received:	February 8, 2012
Last Updated:	April 10, 2012
Health Authority:	Germany: Ministry of Health Italy: Ethics Committee Romania: National Medicines Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration

To Top