Description of the Ability to Learn How to Handle Inhaler Devices in COPD

• Status: Unknown status
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of death in the world and further increase in its prevalence and mortality has been predicted. Currently, the main long-term treatments are the long-acting beta-2 agonist, indacaterol, salmeterol and the anticholinergic drug, tiotropium and glycopyrronium, used alone or in combination:

• long-acting beta-2 agonist with corticosteroid (e.g. salmeterol/fluticasone),

• long-acting beta-2 agonist with anticholinergic (e.g. indacatetrol/glycopyrronium).

These drugs are delivered to the lung using different inhaler devices such as Breezhaler ®, Handihaler® and Diskus®.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Treatments: Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination; Tiotropium Bromide

Criteria

Inclusion Criteria:

• Male or female aged more than 40 years,

• Written informed consent,

• Diagnosis of COPD according to international guidelines (GOLD 2012),

• Social security or health insurance,

• Women of childbearing potential with a very effective contraception according to the Haute Autorité de Santé (HAS) recommendations.

Exclusion Criteria:

• Previous treatment with Breezhaler®, Diskus® or Respimat® or similar device,

• QT ≥ 450 ms,

• Contraindications to tiotropium: hypersensitivity to tiotropium,

• Contraindications to indacatérol: hypersensitivity to indacatérol,

• Contraindications to salmeterol: hypersensitivity to salmeterol,

• Contraindications to fluticasone: hypersensitivity to fluticasone,

• Contraindications to glycopyrronium: hypersensitivity to glycopyrronium,

• COPD exacerbation within 6 weeks before inclusion,

• Chronic psychiatric disease,

• Medical condition that may affect handling of inhaler devices,

• Subject deprived of his/her liberty,

• Protected adult,

• Subject in exclusion period related to another protocol,

• Pregnant or breastfeeding woman