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Clinical Trials/NCT02928744
NCT02928744TerminatedNot Applicable

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

Hopital Foch2 sites in 1 country23 target enrollmentStarted: December 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
23
Locations
2
Primary Endpoint
Percentage of obstruction reversibility

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

COPD

Experimental

Intervention: COPD (Other)

Outcomes

Primary Outcomes

Percentage of obstruction reversibility

Time Frame: 2 hours

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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