NCT02238197

Brief Summary

To obtain further information on the tolerability and efficacy of Atrovent® 500µg/2ml inhalation solution in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice

Trial Health

100
On Track

Trial Health Score

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

Enrollment
477

participants targeted

Target at P75+ for all trials

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, 2001

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2001

Completed
13 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

8 months

First QC Date

September 11, 2014

Last Update Submit

September 11, 2014

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

  • Change in total severity of the clinical picture rated on a 4-point scale

    Up to 4 weeks after first study drug administration

  • Investigator assessment of improvement of the clinical picture of the course on a 6-point symptoms profile

    up to 4 weeks after first study drug administration

Secondary Outcomes (5)

  • Assessment of efficacy by investigator on a 4-point scale

    Up to 4 weeks after first study drug administration

  • Assessment of efficacy by patient on a 4-point scale

    Up to 4 weeks after first study drug administration

  • Assessment of tolerability by investigator on a 4-point scale

    Up to 4 weeks after first study drug administration

  • Assessment of tolerability by patient on a 4-point scale

    Up to 4 weeks after first study drug administration

  • Number of patients with adverse drug reactions

    Up to 4 weeks after first study drug administration

Study Arms (1)

Chronic Obstructive Pulmonary Disease

Drug: Atrovent® Inhalation Solution

Interventions

Atrovent® Inhalation SolutionDRUG
Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Age13 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic obstructive airways disease recruited at pneumologists and internists

You may qualify if:

  • Patients of both genders, older than 40 years,who suffer from chronic obstructive Pulmonary disease

You may not qualify if:

  • Contraindication listed in the instructions for use/summary of product characteristics for Atrovent® 500µg/2ml Inhalation Solution
  • Patients who exhibited adverse drug reactions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2014

First Posted

September 12, 2014

Study Start

February 1, 2001

Primary Completion

October 1, 2001

Last Updated

September 12, 2014

Record last verified: 2014-09