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

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 ...).

Study Overview

• Status: Completed
• Conditions: Severe Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Atrovent + Bricanyl or Atrovent + Ventoline; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • Service de Pneumologie
  • Angers, France, 49033
    • Service de Pneumologie
  • Brest, France, 29609
    • Service de Pneumologie
  • Grenoble, France, 38043
    • Service de Pneumologie
  • Limoges, France, 87042
    • Service de Pneumologie
  • Nancy, France, 54511
    • Service de Pneumologie
  • Nantes, France, 44093
    • Service de Pneumologie
  • Orléans, France, 45067
    • Service de Pneumologie
  • Paris, France, 75004
    • Service de Pneumologie
  • Poitiers, France, 86000
    • Service de Pneumologie
  • Reims, France, 51100
    • Service de Pneumologie
  • Rouen, France, 76031
    • Service de Pneumologie
  • Tours, France, 37044
    • Service de Pneumologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atrovent + Bricanyl or Atrovent + Ventolin; 3 daily inhalations of Atrovent mixture to form Bricanyl or Ventolin form Atrovent 0,5mg/1ml Bricanyl 5mg/2ml Ventolin 5mg/2,5ml	Drug: Atrovent + Bricanyl or Atrovent + Ventoline; 3 daily inhalations of Atrovent mixture to form Bricanyl or Ventolin form during 48 weeks
Placebo Comparator: Placebo; 1 capsule per day lactose (in addition to the standard optimized treatment)	Drug: Placebo; 1 capsule lactose during 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Score for quality of life, assessed by the questionnaire St Georges	Patients will be followed for the duration of their participation ie 48 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Score for quality of life, assessed by the questionnaire VQ11	Patients will be followed for the duration of their participation ie 48 weeks
Dyspnea score according Medical Research Council	Patients will be followed for the duration of their participation ie 48 weeks
Prognostic Score Mortality assessed by the score BODE	Patients will be followed for the duration of their participation ie 48 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Number of exacerbations	Patients will be followed for the duration of their participation ie 48 weeks
Number of hospitalizations	Patients will be followed for the duration of their participation ie 48 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Patrice DIOT, MD-PhD, University Hospital, Tours

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 12, 2014
• First Submitted That Met QC Criteria: March 31, 2014
• First Posted (Estimate): April 3, 2014

Study Record Updates

• Last Update Posted (Estimate): April 27, 2016
• Last Update Submitted That Met QC Criteria: April 26, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: weaned tobacco; Has not submitted an exacerbation in the past 3 months
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Sympathomimetics; Ipratropium; Terbutaline
• Other Study ID Numbers: PHRN10-PD/Nebuadom; 2010-023743-14 (EudraCT Number); 2010-R38 (Other Identifier: CPP); A101466-30 (Other Identifier: Afssaps)