NCT02233920

Brief Summary

Study to obtain further information on the tolerability and efficacy of Ventilat® metered-dose inhaler in the treatment of Chronic Obstructive bronchitis under conditions of daily practice

Trial Health

100
On Track

Trial Health Score

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

Enrollment
716

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

January 1, 2000

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2000

Completed
13.8 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

11 months

First QC Date

September 8, 2014

Last Update Submit

September 8, 2014

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Change in the clinical picture

    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

  • Number of patients with adverse drug reactions

    up to 4 weeks

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

    after 4 weeks

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

    after 4 weeks

Study Arms (1)

Chronic obstructive bronchitis patients

Drug: Ventilat® - metered dose inhaler

Interventions

Ventilat® - metered dose inhalerDRUG
Chronic obstructive bronchitis patients

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with chronic obstructive bronchitis disease recruited at pneumologists

You may qualify if:

  • Primarily Patients of both genders older than 40 years, who suffer from Chronic Obstructive bronchitis

You may not qualify if:

  • Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Ventilat® metered dose inhaler

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 8, 2014

First Posted

September 9, 2014

Study Start

January 1, 2000

Primary Completion

December 1, 2000

Last Updated

September 9, 2014

Record last verified: 2014-09