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

NCT ID: NCT02928744

Last Updated: 2016-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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COPD

Group Type EXPERIMENTAL

COPD

Intervention Type OTHER

Plethysmography

COPD

Intervention Type OTHER

Forced oscillations

Interventions

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COPD

Plethysmography

Intervention Type OTHER

COPD

Forced oscillations

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hélène Neveu

Role: PRINCIPAL_INVESTIGATOR

Hôpital Foch

Locations

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CHRU

Lille, , France

Site Status

Hôpital Foch

Suresnes, , France

Site Status

Countries

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France

References

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Le Rouzic O, Picaud M, Salvator H, Bautin N, Devillier P, Perez T. Residual reversibility in COPD patients already on long-acting bronchodilator: The OscilloRevers Study. Respir Med Res. 2024 Jun;85:101082. doi: 10.1016/j.resmer.2023.101082. Epub 2024 Jan 26.

Reference Type DERIVED
PMID: 38280281 (View on PubMed)

Other Identifiers

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2011-A00964-37

Identifier Type: OTHER

Identifier Source: secondary_id

2011/43

Identifier Type: -

Identifier Source: org_study_id

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