CPASMA: Is There an Improvement in Asthma in Patients With Both Asthma and OSAS Treated With CPAP?

Phase 3

• Conditions: Asthma; Obstructive Sleep Apnea Syndrome
• Interventions: Device: CPAP

• Registration Number: NCT01374932
• Lead Sponsor: Cimera

Brief Summary

The CPASMA trial is a descriptive, prospective, multicentre clinical trial, with a before/after Continuous Positive Airway Pressure (CPAP) assessment in participating patients. It aims to answer the following question: Is there an improvement in asthma in those patients with both asthma and obstructive sleep apnoea syndrome (OSAS) treated with CPAP after six months?. It is hypothesized that treatment of OSAS with CPAP in patients with both OSAS and asthma concommitantly, may have a beneficial effect also on asthma outcomes. This clinical effect in asthma could be assessed objectively by applying validated questionnaires for quality of life and asthma control.

Detailed Description

Full protocol in Spanish, available upon request

Study Timeline

• Study First Submitted: 2011-05-30
• Study First Submitted QC: 2011-06-15
• Study First Posted: 2011-06-16
• Study Start: 2011-07
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-21
• Last Update Posted: 2012-06-22
• Primary Completion: 2012-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Adult patients (18 to 70 yrs.) with asthma who require treatment with CPAP because of OSAS (RDI> = 20 events per hour)

Exclusion Criteria

• unstable or severe comorbidity,
• patients in treatment with drugs that interfere with the clinical course of asthma and/or OSAS,
• cognitive/psychiatric disorders that preclude patient participation/cooperation,
• COPD or other lung disease accompanied by chronic airflow limitation, and
• any clinical condition considered severe enough by the investigators to preclude all the diagnostic and therapeutic procedures outlined in this protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CPAP (see below)	CPAP	Adult patients with asthma who require treatment with CPAP because of OSAS (RDI\> = 20 events per hour). CPAP will be administered according to SEPAR guidelines and tailored to individual characteristics

Primary Outcome Measures

Name	Time	Method
Asthma control questionnaire	6 months	Changes in clinical and functional variables and in the asthma control questionnaire (ACQ) in the period prior to start the CPAP treatment and after a 6-months follow-up period

Trial Locations

Locations (10)

Hospital Universitario Príncipe de Asturias; 🇪🇸 Alcalá de Henares, Madrid, Spain

Hospital de la Santa Creu i de Sant Pau; 🇪🇸 Barcelona, Spain

Hospital comarcal de Inca; 🇪🇸 Inca, Balearic Islands, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Corporació Sanitària Parc Taulí; 🇪🇸 Sabadell., Spain

Hospital de Laredo; 🇪🇸 Cantabria., Spain

Hospital de Jerez; 🇪🇸 Cádiz., Spain

Hospital Universitario Dr. Negrín; 🇪🇸 Las Palmas, Spain

Hospital Moncloa; 🇪🇸 Madrid, Spain

Hospital Universitario Puerta de Hierro; 🇪🇸 Madrid, Spain