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

Asthma Clinical Trial

— CPASMA  

Official title:

The CPASMA Trial: Is There an Improvement in Asthma in Patients With Both Asthma and Obstructive Sleep Apnoea Syndrome (OSAS) Treated With Continuous Positive Airway Pressure (CPAP) After Six Months?

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01374932
• Other study ID #: The CPASMA trial
• Status: Unknown status
• Phase: Phase 3
• First received: May 30, 2011
• Last updated: June 21, 2012
• Start date: July 2011
• Est. completion date: December 2013

Study information

• Verified date: June 2012
• Source: Cimera
• Contact: José Serrano, MD
• Phone: +34-971888500
• Email: jserrano[@]separ.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Full protocol in Spanish, available upon request

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 120
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Asthma
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Device:
• CPAP
Continuous positive airways pressure (CPAP)

Locations

Country	Name	City	State
Spain	Hospital Universitario Príncipe de Asturias	Alcalá de Henares	Madrid
Spain	Hospital de la Santa Creu i de Sant Pau	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital de Jerez	Cádiz.
Spain	Hospital de Laredo	Cantabria.
Spain	Hospital comarcal de Inca	Inca	Balearic Islands
Spain	Hospital Universitario Dr. Negrín	Las Palmas
Spain	Hospital Moncloa	Madrid
Spain	Hospital Universitario Puerta de Hierro	Madrid
Spain	Corporació Sanitària Parc Taulí	Sabadell.

Sponsors (1)

Lead Sponsor	Collaborator
Cimera

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma control questionnaire	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	6 months