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

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Berotec® N 100 µg Metered-dose Inhaler

• Registration Number: NCT02244216
• Lead Sponsor: Boehringer Ingelheim

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-04
• Primary Completion: 2000-06
• Status Verified: 2014-09
• Study First Submitted: 2014-09-18
• Study First Submitted QC: 2014-09-18
• Last Update Submitted: 2014-09-18
• Study First Posted: 2014-09-19
• Last Update Posted: 2014-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2914

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic Obstructive Respiratory Tract Disease	Berotec® N 100 µg Metered-dose Inhaler	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Investigator comparative overall assessment on a 4-point scale	After 3 weeks of first drug administration
Number of patients with adverse drug reactions	Up to 3 weeks after first drug administration
Investigator assessment of efficacy on a 4-point scale	Up to 3 weeks after first drug administration
Patient assessment of efficacy on a 4-point scale	Up to 3 weeks after first drug administration
Number of patients who changed the concomitant medication	Up to 3 weeks after first drug administration
Number of patients who premature withdrew from the treatment	Up to 3 weeks after first drug administration
Patient assessment of tolerability on a 4-point scale	Up to 3 weeks after first drug administration
Number of patients who continued treatment	Up to 3 weeks after first drug administration