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

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ClinicalTrials.gov Identifier: NCT02103374
Recruitment Status : Completed
First Posted : April 3, 2014
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Brief Summary:
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 ...).

Condition or disease Intervention/treatment Phase
Severe Chronic Obstructive Pulmonary Disease Drug: Atrovent + Bricanyl or Atrovent + Ventoline Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Evaluation of Benefit of Nebulized Bronchodilators at Home in Severe Chronic Obstructive Pulmonary Disease and Very Severe Steady State
Study Start Date : January 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103374


Locations
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France
Service de Pneumologie
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
Sponsors and Collaborators
University Hospital, Tours
Investigators
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Principal Investigator: Patrice DIOT, MD-PhD University Hospital, Tours

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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT02103374     History of Changes
Other Study ID Numbers: PHRN10-PD/Nebuadom
2010-023743-14 ( EudraCT Number )
2010-R38 ( Other Identifier: CPP )
A101466-30 ( Other Identifier: Afssaps )
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016
Keywords provided by University Hospital, Tours:
weaned tobacco
Has not submitted an exacerbation in the past 3 months
Additional relevant MeSH terms:
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Ipratropium
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Albuterol
Terbutaline
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents
Sympathomimetics