NCT00465959

Brief Summary

To assess the effect of a single dose of TrIP on pulmonary function in patients with COPD

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_1 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

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

April 1, 2007

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

December 27, 2013

Status Verified

July 1, 2011

Enrollment Period

2 months

First QC Date

April 24, 2007

Last Update Submit

December 3, 2013

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

  • Safety and efficacy (measured by spirometry) of TrIP will be assessed in patients with chronic obstructive pulmonary disease.

Study Arms (3)

400 mg TrIP

EXPERIMENTAL
Drug: trospium chloride inhalation powder (TrIP)

800 mg TrIP

EXPERIMENTAL
Drug: trospium chloride inhalation powder (TrIP)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

trospium chloride inhalation powder (TrIP)DRUG
400 mg TrIP800 mg TrIP
PlaceboDRUG
Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female COPD patients between the ages of 40 and 80 years
  • Smoking history of at least 10 pack years
  • Not currently using (or able to wash out of) any long acting bronchodilators

You may not qualify if:

  • Candidate on a waiting list for surgery while on study
  • Using long-term oxygen therapy
  • Hospitalization for COPD exacerbation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United States Investigational Site

Spartanburg, South Carolina, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 24, 2007

First Posted

April 27, 2007

Study Start

April 1, 2007

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

December 27, 2013

Record last verified: 2011-07

Locations

US(1)