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

Primary Purpose

Asthma, Obstructive Sleep Apnea Syndrome

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
CPAP
Sponsored by
Cimera
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Obstructive Sleep Apnea Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital comarcal de IncaRecruiting
  • Hospital Universitario Príncipe de AsturiasRecruiting
  • Hospital de la Santa Creu i de Sant PauRecruiting
  • Hospital de la Santa Creu i Sant PauRecruiting
  • Hospital de LaredoRecruiting
  • Hospital de JerezRecruiting
  • Hospital Universitario Dr. NegrínRecruiting
  • Hospital MoncloaRecruiting
  • Hospital Universitario Puerta de HierroRecruiting
  • Corporació Sanitària Parc TaulíRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CPAP (see below)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 30, 2011
Last Updated
June 21, 2012
Sponsor
Cimera
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1. Study Identification

Unique Protocol Identification Number
NCT01374932
Brief Title
CPASMA: Is There an Improvement in Asthma in Patients With Both Asthma and OSAS Treated With CPAP?
Acronym
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?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cimera

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Obstructive Sleep Apnea Syndrome
Keywords
Asthma, Obstructive Sleep Apnea Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPAP (see below)
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
CPAP
Other Intervention Name(s)
Brand names will be added during fieldwork
Intervention Description
Continuous positive airways pressure (CPAP)
Primary Outcome Measure Information:
Title
Asthma control questionnaire
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
José Serrano, MD
Phone
+34-971888500
Ext
4020
Email
jserrano@separ.es
First Name & Middle Initial & Last Name or Official Title & Degree
Joan B Soriano, MD
Email
jbsoriano@caubet-cimera.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Serrano, MD
Organizational Affiliation
Hospital de Inca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital comarcal de Inca
City
Inca
State/Province
Balearic Islands
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Serrano, MD
Email
jserrano@separ.es
First Name & Middle Initial & Last Name & Degree
José Serrano, MD
Facility Name
Hospital Universitario Príncipe de Asturias
City
Alcalá de Henares
State/Province
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soledad Alonso Viteri, MD
Facility Name
Hospital de la Santa Creu i de Sant Pau
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicente Plaza Moral, MD
Email
vplaza@santpau.cat
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merce Mayos Perez, MD
Facility Name
Hospital de Laredo
City
Cantabria.
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Luis García Rivero, MD
Facility Name
Hospital de Jerez
City
Cádiz.
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Gregorio Soto Campos, MD
Facility Name
Hospital Universitario Dr. Negrín
City
Las Palmas
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Cabrera López, MD
Facility Name
Hospital Moncloa
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sagrario Mayoralas Alises, MD
Facility Name
Hospital Universitario Puerta de Hierro
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antolin Lopez Viña, MD
Email
alopezv@separ.es
Facility Name
Corporació Sanitària Parc Taulí
City
Sabadell.
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Isabel Sogo Sagardia, MD
First Name & Middle Initial & Last Name & Degree
Laura Vigil Giménez., MD

12. IPD Sharing Statement

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

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