NCT02236715

Brief Summary

Study to obtain further information on the tolerability and efficacy of Atrovent® unit dose vial 500 µg 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
1,039

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

September 1, 1999

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2000

Completed
14.6 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

5 months

First QC Date

September 10, 2014

Last Update Submit

September 10, 2014

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

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

    after 4 weeks

Secondary Outcomes (5)

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

    after 4 weeks

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

    after 4 weeks

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

    after 4 weeks

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

    after 4 weeks

  • Number of patients with adverse drug reactions

    up to 4 weeks

Study Arms (1)

Chronic Obstructive Airways Disease

Drug: Atrovent®

Interventions

Atrovent®DRUG
Chronic Obstructive Airways Disease

Eligibility Criteria

Age30 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 of both gender, older than 30 years, who suffer from chronic obstructive airways disease

You may not qualify if:

  • Contraindication listed in the instructions for use/summary of product characteristics for Atrovent® unit dose vial 500 µg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ipratropium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Atropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Design

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

Study Record Dates

First Submitted

September 10, 2014

First Posted

September 11, 2014

Study Start

September 1, 1999

Primary Completion

February 1, 2000

Last Updated

September 11, 2014

Record last verified: 2014-09