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

NCT01374932 | Unknown Phase 3

• 1 other identifier: The CPASMA trial
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 10

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.

Conditions

Asthma; Obstructive Sleep Apnea Syndrome

Keywords

Asthma; Obstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

CPAP (see below)

EXPERIMENTAL

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

Device: CPAP

Interventions

CPAP DEVICE

Continuous positive airways pressure (CPAP)

Also known as: Brand names will be added during fieldwork

CPAP (see below)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cimera: lead

Study Sites (10)

Hospital comarcal de Inca

Inca, Balearic Islands, Spain

RECRUITING

Hospital Universitario Príncipe de Asturias

Alcalá de Henares, Madrid, Spain

RECRUITING

Hospital de la Santa Creu i de Sant Pau

Barcelona, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

RECRUITING

Hospital de Jerez

Cadiz, Spain

RECRUITING

Hospital de Laredo

Cantabria., Spain

RECRUITING

Hospital Universitario Dr. Negrín

Las Palmas, Spain

RECRUITING

Hospital Moncloa

Madrid, Spain

RECRUITING

Hospital Universitario Puerta de Hierro

Madrid, Spain

RECRUITING

Corporació Sanitària Parc Taulí

Sabadell, Spain

RECRUITING

MeSH Terms

Conditions

Asthma; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jose Serrano, MD

  Hospital de Inca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José Serrano, MD

CONTACT

+34-971888500; jserrano@separ.es

Joan B Soriano, MD

CONTACT

jbsoriano@caubet-cimera.es

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Programme Director

Study Record Dates

• First Submitted: May 30, 2011
• First Posted: June 16, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: June 22, 2012

Record last verified: 2012-06

Locations

ES (10)