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Completed

NCT Number: NCT02244216

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

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

Completed

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Berotec® N 100 µg Metered-dose Inhaler

Drug

Primary outcomes

  1. Change in the clinical picture of chronic obstructive airways disease on switching from Berotec® 200 µg to Berotec® N 100 µg

    Time frame: After 3 weeks of first drug administration

Secondary outcomes

  1. Investigator assessment of efficacy on a 4-point scale

    Time frame: Up to 3 weeks after first drug administration

  2. Patient assessment of efficacy on a 4-point scale

    Time frame: Up to 3 weeks after first drug administration

  3. Patient assessment of tolerability on a 4-point scale

    Time frame: Up to 3 weeks after first drug administration

  4. Investigator comparative overall assessment on a 4-point scale

    Time frame: After 3 weeks of first drug administration

  5. Number of patients with adverse drug reactions

    Time frame: Up to 3 weeks after first drug administration

  6. Number of patients who changed the concomitant medication

    Time frame: Up to 3 weeks after first drug administration

  7. Number of patients who continued treatment

    Time frame: Up to 3 weeks after first drug administration

  8. Number of patients who premature withdrew from the treatment

    Time frame: Up to 3 weeks after first drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2000
Primary completion
2000
First posted
Sep 19, 2014
Registry last updated
Sep 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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