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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Cimera.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Joan B Soriano, Cimera
ClinicalTrials.gov Identifier:
NCT01374932
First received: May 30, 2011
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Asthma
Obstructive Sleep Apnea Syndrome
Device: CPAP
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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?

Resource links provided by NLM:


Further study details as provided by Cimera:

Primary Outcome Measures:
  • Asthma control questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 120
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Full protocol in Spanish, available upon request

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Sant Pau Recruiting
Barcelona, Spain
Contact: Merce Mayos Perez, MD         
Hospital de la Santa Creu i de Sant Pau Recruiting
Barcelona, Spain
Contact: Vicente Plaza Moral, MD       vplaza@santpau.cat   
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 Universitario Puerta de Hierro Recruiting
Madrid, Spain
Contact: Antolin Lopez Viña, MD       alopezv@separ.es   
Hospital Moncloa Recruiting
Madrid, Spain
Contact: Sagrario Mayoralas Alises, MD         
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
  More Information

No publications provided

Responsible Party: Dr. Joan B Soriano, Programme Director, Cimera
ClinicalTrials.gov Identifier: NCT01374932     History of Changes
Other Study ID Numbers: The CPASMA trial
Study First Received: May 30, 2011
Last Updated: June 21, 2012
Health Authority: Spain: Ethics Committee

Keywords provided by Cimera:
Asthma
Obstructive Sleep Apnea Syndrome

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

ClinicalTrials.gov processed this record on October 20, 2014