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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02103374
Other study ID # PHRN10-PD/Nebuadom
Secondary ID 2010-023743-1420
Status Completed
Phase Phase 4
First received March 12, 2014
Last updated April 26, 2016
Start date January 2012
Est. completion date December 2015

Study information

Verified date April 2016
Source University Hospital, Tours
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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 ...).


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)


Related Conditions & MeSH terms


Intervention

Drug:
Atrovent + Bricanyl or Atrovent + Ventoline
3 daily inhalations of Atrovent mixture to form Bricanyl or Ventolin form during 48 weeks
Placebo
1 capsule lactose during 48 weeks

Locations

Country Name City State
France Service de Pneumologie Amiens
France Service de Pneumologie Angers
France Service de Pneumologie Brest
France Service de Pneumologie Grenoble
France Service de Pneumologie Limoges
France Service de Pneumologie Nancy
France Service de Pneumologie Nantes
France Service de Pneumologie Orléans
France Service de Pneumologie Paris
France Service de Pneumologie Poitiers
France Service de Pneumologie Reims
France Service de Pneumologie Rouen
France Service de Pneumologie Tours

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of exacerbations Patients will be followed for the duration of their participation ie 48 weeks Yes
Other Number of hospitalizations Patients will be followed for the duration of their participation ie 48 weeks Yes
Primary Score for quality of life, assessed by the questionnaire St Georges Patients will be followed for the duration of their participation ie 48 weeks No
Secondary Score for quality of life, assessed by the questionnaire VQ11 Patients will be followed for the duration of their participation ie 48 weeks No
Secondary Dyspnea score according Medical Research Council Patients will be followed for the duration of their participation ie 48 weeks No
Secondary Prognostic Score Mortality assessed by the score BODE Patients will be followed for the duration of their participation ie 48 weeks No
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