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

NCT02928744 | Terminated

• 2 other identifiers: 2011/432011-A00964-37
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

COPD

Keywords

Resistance; Forced oscillations; Dyspnea

Outcome Measures

Primary Outcomes (1)

• Percentage of obstruction reversibility

  2 hours

Study Arms (1)

COPD

EXPERIMENTAL

Other: COPD

Interventions

COPD OTHER

Plethysmography

COPD

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (2)

CHRU

Lille, 59000, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

Related Publications (1)

• 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.

  PMID: 38280281 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

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

Study Officials

• Hélène Neveu

  Hôpital Foch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 10, 2016
• Study Start: December 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: January 1, 2016
• Last Updated: October 12, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)