Postmarketing Surveillance Study of Berotec® N 100 µg Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law]) of Berotec® N 100 µg Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02244216
• Other study ID #: 260.3178
• Status: Completed
• Phase: N/A
• First received: September 18, 2014
• Last updated: September 18, 2014
• Start date: April 2000

Study information

• Verified date: September 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

Study to obtain data about changing from the chlorofluorocarbon (CFC) - containing Berotec® 200 µg metered - dose inhaler to the CFC - free Berotec® N 100 µg metered - dose inhaler

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2914
• Est. primary completion date: June 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients were included in the study only if they had been treated with Berotec® 200 µg metered - dose inhaler before switching to the CFC-free Berotec® N 100 µg metered
• dose inhaler

Exclusion Criteria:

• Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Berotec® N 100 µg metered - dose inhaler

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Pulmonary Disease, Chronic Obstructive
• Respiratory Tract Diseases

Intervention

Drug:
• Berotec® N 100 µg Metered-dose Inhaler

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the clinical picture of chronic obstructive airways disease on switching from Berotec® 200 µg to Berotec® N 100 µg		After 3 weeks of first drug administration	No
Secondary	Investigator assessment of efficacy on a 4-point scale		Up to 3 weeks after first drug administration	No
Secondary	Patient assessment of efficacy on a 4-point scale		Up to 3 weeks after first drug administration	No
Secondary	Patient assessment of tolerability on a 4-point scale		Up to 3 weeks after first drug administration	No
Secondary	Investigator comparative overall assessment on a 4-point scale		After 3 weeks of first drug administration	No
Secondary	Number of patients with adverse drug reactions		Up to 3 weeks after first drug administration	No
Secondary	Number of patients who changed the concomitant medication		Up to 3 weeks after first drug administration	No
Secondary	Number of patients who continued treatment		Up to 3 weeks after first drug administration	No
Secondary	Number of patients who premature withdrew from the treatment		Up to 3 weeks after first drug administration	No

External Links

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