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OpenTrials
Completed

NCT Number: NCT02233907

Post-marketing Surveillance of Ventilat® in Long-term Therapy in Chronic Obstructive Pulmonary Disease

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

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

Age range

40 year and older

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 of both genders older than 40 years, who suffer from Chronic Obstructive Pulmonary Disease
  • Only patients who have not been treated with Ventilat® within the last year are to be considered for inclusion

Exclusion criteria

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

Treatment and study plan

Ventilat® - metered dose inhaler

Drug

Primary outcomes

  1. Change in the clinical picture

    Time frame: up to 12 months

Secondary outcomes

  1. Assessment of efficacy by investigator on a 4-point scale

    Time frame: after 12 months

  2. Assessment of efficacy by patient on a 4-point scale

    Time frame: after 12 months

  3. Number of patients with adverse drug reactions

    Time frame: up to 12 months

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

    Time frame: after 12 months

  5. Assessment of tolerability by patient on a 4-point scale

    Time frame: after 12 months

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Post-marketing Surveillance (as Per § 67(6) AMG [German Drug Law]) of Ventilat® in Long-term Therapy in Chronic Obstructive Pulmonary Disease

Important dates

Study start
1999
Primary completion
2001
First posted
Sep 9, 2014
Registry last updated
Sep 9, 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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