CClinicalTrials.gg
CompletedNCT02231437Updated Sep 4, 2014

Post-marketing Surveillance of Berodual® Metered-dose Inhaler in the Treatment of Chronic Obstructive Respiratory Tract Disease

An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2014-09-04.

Sponsored by Boehringer Ingelheim · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,488
Ages
6 Years and older
Sex
All
01

Study summary

The aim of this post-marketing surveillance is to obtain further information about the tolerability of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice

02

Conditions studied

  • Pulmonary Disease, Chronic Obstructive
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's enrollment of 3,488 is above the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

general practitioners, pneumologists and internists

Inclusion criteria

  • Patients with diagnosis of Chronic obstructive respiratory tract disease
  • Patients of either sex, including children over 6 years

Exclusion criteria

Exclusion Criteria:

  • Contraindications listed in the Instructions of Use/Summary of Product Characteristics of Berodual® metered-dose inhaler
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,488 participants (actual)
Patient registry
No

Groups and cohorts

  • chronic obstructive respiratory tract disease patients

    Drug: Berodual®

Interventions

  • DrugBerodual®
06

What researchers measure

Primary outcomes

  1. Overall severity of the clinical picture rated on a 4-point scale

    Time frame: after 3 and 6 weeks

Secondary outcomes

  1. Changes in dyspnea and/or asthma attacks rated on a 4-point scale

    Time frame: after 3 and 6 weeks

  2. Number of dyspnea episodes rated on a 4-point scale

    Time frame: after 3 and 6 weeks

  3. Number of awakenings due to night-time dyspnea rated on a 4-point scale

    Time frame: after 3 and 6 weeks

  4. Assessment of morning coughing with expectoration on a 4-point scale

    Time frame: after 3 and 6 weeks

  5. Assessment of tolerability on a 4-point scale

    Time frame: after 3 and 6 weeks

  6. Number of patients with adverse drug reactions

    Time frame: up to 6 weeks

  7. Changes in pathological auscultation findings rated on a 3-point scale

    Time frame: after 3 and 6 weeks

  8. Changes in concomitant medication

    Time frame: up to 6 weeks

  9. Assessment of efficacy on a 4-point scale

    Time frame: after 3 and 6 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02231437
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Sep 4, 2014
Start date
Jan 1999
Primary completion
Nov 1999
Last update
Sep 4, 2014
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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