OSCILLOREVERS: 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

• Sponsor: Hopital Foch (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02928744
• Collaborator: (none)
• Enrollment: 23
• Locations: 2
• Arm: 1
• Duration (Months): 49
• Patients Per Site: 11.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD	Other: COPD; Other: COPD	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: COPD	Other: COPD; Plethysmography; Other: COPD; Forced oscillations

Outcome Measures

Primary Outcome Measures

1. Percentage of obstruction reversibility [2 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU	Lille		France	59000
2	Hôpital Foch	Suresnes		France	92150

Sponsors and Collaborators

• Hopital Foch

Investigators

• Principal Investigator: Hélène Neveu, Hôpital Foch

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hopital Foch
• ClinicalTrials.gov Identifier: NCT02928744
• Other Study ID Numbers: 2011/43; 2011-A00964-37
• First Posted: Oct 10, 2016
• Last Update Posted: Oct 12, 2016
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Hopital Foch: Resistance; Forced oscillations; Dyspnea
• Additional relevant MeSH terms: Dyspnea

Study Results

No Results Posted as of Oct 12, 2016