NCT02238132

Brief Summary

To obtain further information on the tolerability of Atrovent® inhalets in the treatment of Chronic Obstructive Airways 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
374

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

December 1, 1998

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 1999

Completed
14.9 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

11 months

First QC Date

September 11, 2014

Last Update Submit

September 11, 2014

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

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

    Up to 4 weeks after first study drug administration

Secondary Outcomes (8)

  • Investigator assessment of efficacy on a 4-point scale

    Up to 4 weeks after first study drug administration

  • Investigator assessment of tolerability 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

  • Number of patients who withdrew from the study

    Up to 4 weeks after first study drug administration

  • Number of patients who changed the concomitant medication

    Up to 4 weeks after first study drug administration

  • +3 more secondary outcomes

Study Arms (1)

Chronic Obstructive Airways Disease

Drug: ATROVENT® inhalets

Interventions

ATROVENT® inhaletsDRUG
Chronic Obstructive Airways Disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic obstructive airways disease recruited at general practitioners, pneumologists, internists

You may qualify if:

  • Primarily, Patients with chronic obstructive airways disease

You may not qualify if:

  • \- Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® inhalets

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

December 1, 1998

Primary Completion

November 1, 1999

Last Updated

September 12, 2014

Record last verified: 2014-09