NCT00856193

Brief Summary

This study was intended to assess how well inhaled NVA237 opens up the airways of patients with mild, moderate or severe COPD over a 24 hour period after a 14 day treatment period.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_2 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_2 chronic-obstructive-pulmonary-disease

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
2 years until next milestone

Results Posted

Study results publicly available

May 6, 2011

Completed
Last Updated

September 14, 2016

Status Verified

June 1, 2011

Enrollment Period

3 months

First QC Date

March 4, 2009

Results QC Date

January 20, 2011

Last Update Submit

August 2, 2016

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDBronchodilator

Outcome Measures

Primary Outcomes (1)

  • Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14

    Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from predose (day 1) to the readings taken 0-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.

    From Day 1 to 0-24 hours after drug administration on Day 14

Secondary Outcomes (3)

  • Forced Expiratory Volume in One Second (FEV1) AUC 0-12 Hours on Day 14

    From day 1 to 0 -12 hours after drug administration on Day 14

  • Forced Expiratory Volume in One Second (FEV1) AUC 12-24 Hours on Day 14

    From Day 1 to 12 hours-24 hours after drug administration on Day 14

  • Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs)

    Day 14

Study Arms (2)

Placebo then NVA237 50μg

PLACEBO COMPARATOR

Placebo 50 μg capsules followed by NVA237 50 μg capsules for inhalation once daily with Concept 1 device.

Drug: PlaceboDrug: NVA237

NVA237 50μg then placebo

EXPERIMENTAL

NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device.

Drug: PlaceboDrug: NVA237

Interventions

PlaceboDRUG

Matching placebo capsules were supplied for inhalation once daily with Concept 1 device.

NVA237 50μg then placeboPlacebo then NVA237 50μg
NVA237DRUG

NVA237 50 μg capsules were supplied for inhalation once daily with Concept 1 device.

NVA237 50μg then placeboPlacebo then NVA237 50μg

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged greater than 40 years with COPD Current or ex-smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Harrison Clinical Research Deutschland GmbH

Albrechtstrasse 14, Munich, 80636, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycopyrrolate

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2009

First Posted

March 5, 2009

Study Start

February 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

September 14, 2016

Results First Posted

May 6, 2011

Record last verified: 2011-06

Locations

DE(1)US(1)