NCT00274534

Brief Summary

To evaluate changes in PaO2 following inhalation of Tiotropium by HandiHaler compared to Salmeterol MDI in patients with moderate to severe COPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2000

Typical duration for phase_3

Geographic Reach
1 country

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

December 1, 2000

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2006

Completed
Last Updated

November 5, 2013

Status Verified

November 1, 2013

First QC Date

January 9, 2006

Last Update Submit

November 4, 2013

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • The change from baseline (Visit 2) in the PaO2 area under the curve (AUC) for the time period 0 to 105 minutes obtained through arterial blood gases (ABGs) at the end of each treatment period.

    up to day 90

Secondary Outcomes (8)

  • Maximum decline in PaO2 from baseline

    up to day 90

  • Maximum increase in alveolar-arterial oxygen gradient from baseline

    up to day 90

  • Change from baseline (Visit 2) in FEV1 prior to insertion of catheter and 15 minutes post removal of catheter

    up to day 90

  • Change from baseline (Visit 2) in FVC prior to insertion of catheter and 15 minutes post removal of catheter

    up to day 90

  • Rescue medication use

    up to day 90

  • +3 more secondary outcomes

Interventions

TiotropiumDRUG
SalmeterolDRUG

Sponsors & Collaborators

Study Sites (2)

Hines Veterans Administration Hospital

Hines, Illinois, United States

Location

Hunter Holmes McGuire Medical Center

Richmond, Virginia, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium BromideSalmeterol Xinafoate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingAlbuterolEthanolaminesAmino AlcoholsAlcoholsAminesPhenethylaminesEthylamines

Study Officials

  • Boehringer Ingelheim Study Coordinator

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 9, 2006

First Posted

January 11, 2006

Study Start

December 1, 2000

Study Completion

July 1, 2003

Last Updated

November 5, 2013

Record last verified: 2013-11

Locations

US(2)