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Completed

NCT Number: NCT02103374

Evaluation of Benefit of Nebulized Bronchodilators at Home in Severe Chronic Obstructive Pulmonary Disease and Very Severe Steady State

Design studies of nebulization in COPD does not respond adequately to the clinically relevant question: the intervention of administering nebulized bronchodilators at home it is likely to make a profit, compared to the standard optimized treatment as defined by the recommendations of the SPLF, patients with severe COPD (stage III, FEV between 30% and 50% of the theoretical value) and very severe (stage IV, less than 30% of the theoretical value FEV)? The concept of profit in this context is based on criteria of dyspnea, quality of life, use of health system (exacerbations, hospitalizations, prescription of antibiotics and steroids ...).

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Service de Pneumologie, Amiens, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult
  • COPD Patients stage 3 et 4
  • Has not submitted an exacerbation in the 3 months preceding the pre-inclusion visit
  • Weaned from tobacco for at least 6 months
  • vaccinated against pneumococcal
  • Have not been included in a pulmonary rehabilitation program during the 6 months preceding the screening visit inclusion
  • Patient pre-included not showing exacerbation since the pre-inclusion visit

Exclusion criteria

  • Patient under nebulizer or has been treated with nebulized bronchodilators at home over the last 6 months
  • Patient with an indication of oxygen is expected in the coming year
  • Progressive malignant disease known
  • Patient under non-invasive ventilation (NIV) for less than 6 months or NIV provided in the following year
  • Patient known to be colonized by Pseudomonas aeruginosa, A. xylosoxidans, Burkholderia cepacia or Stenotrophomonas maltophilia
  • Patients with severe cardiovascular disease
  • Pregnancy

Treatment and study plan

Atrovent + Bricanyl or Atrovent + Ventoline

Drug

3 daily inhalations of Atrovent mixture to form Bricanyl or Ventolin form during 48 weeks

Placebo

Drug

1 capsule lactose during 48 weeks

Primary outcomes

  1. Score for quality of life, assessed by the questionnaire St Georges

    Time frame: Patients will be followed for the duration of their participation ie 48 weeks

Secondary outcomes

  1. Score for quality of life, assessed by the questionnaire VQ11

    Time frame: Patients will be followed for the duration of their participation ie 48 weeks

  2. Dyspnea score according Medical Research Council

    Time frame: Patients will be followed for the duration of their participation ie 48 weeks

  3. Prognostic Score Mortality assessed by the score BODE

    Time frame: Patients will be followed for the duration of their participation ie 48 weeks

Other outcomes

  1. Number of exacerbations

    Time frame: Patients will be followed for the duration of their participation ie 48 weeks

  2. Number of hospitalizations

    Time frame: Patients will be followed for the duration of their participation ie 48 weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: Nebuadom

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 3, 2014
Registry last updated
Apr 27, 2016

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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