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

June 21, 2012 updated by: Dr. Joan B Soriano, Cimera

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?

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Full protocol in Spanish, available upon request

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital de la Santa Creu i de Sant Pau
        • Contact:
      • Barcelona, Spain
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Contact:
          • Merce Mayos Perez, MD
      • Cantabria., Spain
        • Recruiting
        • Hospital de Laredo
        • Contact:
          • Juan Luis García Rivero, MD
      • Cádiz., Spain
        • Recruiting
        • Hospital de Jerez
        • Contact:
          • José Gregorio Soto Campos, MD
      • Las Palmas, Spain
        • Recruiting
        • Hospital Universitario Dr. Negrín
        • Contact:
          • Carlos Cabrera López, MD
      • Madrid, Spain
        • Recruiting
        • Hospital Moncloa
        • Contact:
          • Sagrario Mayoralas Alises, MD
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Puerta de Hierro
        • Contact:
      • Sabadell., Spain
        • Recruiting
        • Corporacio Sanitaria Parc Tauli
        • Contact:
          • Ana Isabel Sogo Sagardia, MD
        • Sub-Investigator:
          • Laura Vigil Giménez., MD
    • Balearic Islands
      • Inca, Balearic Islands, Spain
        • Recruiting
        • Hospital Comarcal de Inca
        • Contact:
        • Principal Investigator:
          • José Serrano, MD
    • Madrid
      • Alcalá de Henares, Madrid, Spain
        • Recruiting
        • Hospital Universitario Príncipe de Asturias
        • Contact:
          • Soledad Alonso Viteri, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CPAP (see below)
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
Continuous positive airways pressure (CPAP)
Other Names:
  • Brand names will be added during fieldwork

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma control questionnaire
Time Frame: 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cimera

Investigators

  • Principal Investigator: Jose Serrano, MD, Hospital de Inca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ANTICIPATED)

December 1, 2012

Study Completion (ANTICIPATED)

December 1, 2013

Study Registration Dates

First Submitted

May 30, 2011

First Submitted That Met QC Criteria

June 15, 2011

First Posted (ESTIMATE)

June 16, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 22, 2012

Last Update Submitted That Met QC Criteria

June 21, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The CPASMA trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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