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

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ClinicalTrials.gov Identifier: NCT01374932
Recruitment Status : Unknown
Verified June 2012 by Dr. Joan B Soriano, Cimera.
Recruitment status was:  Recruiting
First Posted : June 16, 2011
Last Update Posted : June 22, 2012
Sponsor:
Information provided by (Responsible Party):
Dr. Joan B Soriano, 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.

Condition or disease Intervention/treatment Phase
Asthma Obstructive Sleep Apnea Syndrome Device: CPAP Phase 3

Detailed Description:
Full protocol in Spanish, available upon request

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Sleep Apnea
U.S. FDA Resources

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 Name: Brand names will be added during fieldwork



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01374932


Contacts
Contact: José Serrano, MD +34-971888500 ext 4020 jserrano@separ.es
Contact: Joan B Soriano, MD jbsoriano@caubet-cimera.es

Locations
Spain
Hospital comarcal de Inca Recruiting
Inca, Balearic Islands, Spain
Contact: José Serrano, MD       jserrano@separ.es   
Principal Investigator: José Serrano, MD         
Hospital Universitario Príncipe de Asturias Recruiting
Alcalá de Henares, Madrid, Spain
Contact: Soledad Alonso Viteri, MD         
Hospital de la Santa Creu i de Sant Pau Recruiting
Barcelona, Spain
Contact: Vicente Plaza Moral, MD       vplaza@santpau.cat   
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain
Contact: Merce Mayos Perez, MD         
Hospital de Laredo Recruiting
Cantabria., Spain
Contact: Juan Luis García Rivero, MD         
Hospital de Jerez Recruiting
Cádiz., Spain
Contact: José Gregorio Soto Campos, MD         
Hospital Universitario Dr. Negrín Recruiting
Las Palmas, Spain
Contact: Carlos Cabrera López, MD         
Hospital Moncloa Recruiting
Madrid, Spain
Contact: Sagrario Mayoralas Alises, MD         
Hospital Universitario Puerta de Hierro Recruiting
Madrid, Spain
Contact: Antolin Lopez Viña, MD       alopezv@separ.es   
Corporació Sanitària Parc Taulí Recruiting
Sabadell., Spain
Contact: Ana Isabel Sogo Sagardia, MD         
Sub-Investigator: Laura Vigil Giménez., MD         
Sponsors and Collaborators
Cimera
Investigators
Principal Investigator: Jose Serrano, MD Hospital de Inca

Responsible Party: Dr. Joan B Soriano, Programme Director, Cimera
ClinicalTrials.gov Identifier: NCT01374932     History of Changes
Other Study ID Numbers: The CPASMA trial
First Posted: June 16, 2011    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012

Keywords provided by Dr. Joan B Soriano, Cimera:
Asthma
Obstructive Sleep Apnea Syndrome

Additional relevant MeSH terms:
Syndrome
Asthma
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Disease
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases