Evaluation of the Reversibility of the Bronchial Obstruction by Impulse Oscillometry Technique in Chronic Obstructive Pulmonary Disease (COPD): Correlation With Functional Features Measured by Plethysmography and Dyspnoea

COPD Clinical Trial

— OSCILLOREVERS  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02928744
• Other study ID #: 2011/43
• Secondary ID: 2011-A00964-37
• Status: Terminated
• Phase: N/A
• First received: October 7, 2016
• Last updated: October 10, 2016
• Start date: December 2011
• Est. completion date: January 2016

Study information

• Verified date: October 2016
• Source: Hopital Foch
• 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

Limitation of expiratory flows is considered as the main determiner of dynamic distension and dyspnoea in chronic obstructive pulmonary disease (COPD). The analysis of proximal and distal resistances should allow to better appreciate the functional impact.

This study should also allow to specify the best parameters in respiratory functional explorations useful for the follow-up in COPD and to specify the relevance of functional indications other than the forced expiration volume at 1 second (FEV1) or the functional residual capacity (FRC) to estimate in a more relevant way the clinical improve with the increase of the therapeutic load (increase of posology, association of two bronchodilatators, addition of an anti-inflammatory drug, thus etc…) at already handled patients suffering from a persistent dyspnoea insufficiently relieved.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: January 2016
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• COPD with dyspnoea with Medical Research Council scale (MRC) >1,

• No exacerbation for 6 weeks

• No bronchodilatator short action(share) (ß 2 agonist or ipratropium) within 6 hours before the respiratory evaluation and the test of reversibility.

• Patient under current treatment (ß2 long-acting agonist (LABA) or anticholinergic long-acting (LLAMA(LAMA)) or LABA-corticoid association inhaled (CSI), or triples LABA-CSI-LAMA association) stable for at least 4 weeks, and taken for at least the 1 hour the day of the visit

• Having given a written consent

Exclusion Criteria:

• Patient Under 18

• Other respiratory illness

• Clinically significant left cardiac failure

• Obesity with BMI > 35 kg / m2)

• Unable to perform respiratory evaluations

• Contraindication to the salbutamol or to the ipratropium bromide or to one of its components

• Pregnant or breast-feeding woman

• Unable to agree

• No social security scheme

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• COPD
Plethysmography
• COPD
Forced oscillations

Locations

Country	Name	City	State
France	CHRU	Lille
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of obstruction reversibility		2 hours	No