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

NCT02103374 | Completed Phase 4 DMC

• 4 other identifiers: PHRN10-PD/Nebuadom2010-023743-142010-R38A101466-30
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 13

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 ...).

Conditions

Severe Chronic Obstructive Pulmonary Disease

Keywords

weaned tobacco; Has not submitted an exacerbation in the past 3 months

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (2)

Atrovent + Bricanyl or Atrovent + Ventolin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

1 capsule per day lactose (in addition to the standard optimized treatment)

Drug: Placebo

Interventions

Atrovent + Bricanyl or Atrovent + Ventoline DRUG

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

Atrovent + Bricanyl or Atrovent + Ventolin

Placebo DRUG

1 capsule lactose during 48 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult
• COPD Patients stage 3 et 4
• Weaned from tobacco for at least 6 months
• vaccinated against pneumococcal

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (13)

Service de Pneumologie

Amiens, 80054, France

Location

Service de Pneumologie

Angers, 49033, France

Location

Service de Pneumologie

Brest, 29609, France

Location

Service de Pneumologie

Grenoble, 38043, France

Location

Service de Pneumologie

Limoges, 87042, France

Location

Service de Pneumologie

Nancy, 54511, France

Location

Service de Pneumologie

Nantes, 44093, France

Location

Service de Pneumologie

Orléans, 45067, France

Location

Service de Pneumologie

Paris, 75004, France

Location

Service de Pneumologie

Poitiers, 86000, France

Location

Service de Pneumologie

Reims, 51100, France

Location

Service de Pneumologie

Rouen, 76031, France

Location

Service de Pneumologie

Tours, 37044, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ipratropium; Terbutaline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Ethanolamines; Amino Alcohols; Alcohols; Amines

Study Officials

• Patrice DIOT, MD-PhD

  University Hospital, Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: April 3, 2014
• Study Start: January 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 27, 2016

Record last verified: 2016-04

Locations

FR (13)