Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Spartanburg, South Carolina 29303


Purpose:

The ability for patients with COPD to exercise is limited due to the deterioration of their lung function. NVA237 is being developed to treat COPD. This study is designed to look at how well NVA237 improves the ability to exercise in patients with moderate to severe COPD.


Criteria:

Inclusion Criteria: - Male or female adults (aged 40 years and over) with a clinical diagnosis of moderate to severe COPD with a smoking history of at least 10 cigarettes pack years. - Patients with a post-bronchodilator FEV1 ≥35% and < 70% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 during screening. - Increase in FEV1 from Pre-bronchodilator to Post-bronchodilator assessment of at least 5% Exclusion Criteria: - Pregnant or nursing mothers, women of child bearing potential unless using a reliable contraception method, Cardiac (heart) disorders, history of asthma, requiring oxygen therapy, treatment with certain COPD medication, on another investigational study, limitations on the exercise test due to non-respiratory conditions. - Other criteria applies


Study is Available At:


Original ID:

CNVA237A2310


NCT ID:

NCT01154127


Secondary ID:

2010-018597-20


Study Acronym:

GLOW3


Brief Title:

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


Official Title:

A Multi-center, Randomized, Double-blind, Placebo-controlled, Two-period Cross-over Study to Assess the Effect of 50µg Inhaled NVA237 on Exercise Endurance in Patients With Moderate to Severe COPD


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

40 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novartis


Oversight 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


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Cros


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

108


Enrollment Type:

Actual


Overall Contact Information

Official Name:Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Study Dates

Start Date:June 2010
Completion Date:February 2011
Completion Type:Actual
Primary Completion Date:February 2011
Primary Completion Type:Actual
Verification Date:September 2011
Last Changed Date:September 5, 2011
First Received Date:June 29, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Measure: To evaluate the effects of 5050µg NVA237 compared with placebo on exertional dyspnea during SMETT
Time Frame:Three weeks after treatment
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Measure: To determine the effect of 50 µg NVA237 compared with placebo on inspiratory capacity at rest and at peak during SMETT.
Time Frame:Three weeks after treatment
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Measure: To determine the effect of 50µg NVA237 compared with placebo on isotime inspiratory capacity (IC) during SMETT.
Time Frame:Three weeks after treatment
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Measure: To determine the effect of 50µg NVA237 compared with matched placebo inhaled once daily on exercise tolerance as measured by exercise endurance time during a sub-maximal constant-load cycle ergometry test (SMETT).
Time Frame:Three weeks after treatment
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:NVA237
Arm Name:NVA237
Intervention Type:Drug
Name:NVA237 Placebo
Arm Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Study Arm Type:Experimental
Arm Name:NVA237

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novartis Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.