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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

May 30, 2011
June 16, 2011
June 22, 2012
July 2011
December 2012   (Final data collection date for primary outcome measure)
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
Asthma control questionnaire [ Time Frame: 3 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 3-months follow-up period
Complete list of historical versions of study NCT01374932 on ClinicalTrials.gov Archive Site
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CPASMA: Is There an Improvement in Asthma in Patients With Both Asthma and OSAS Treated With CPAP?
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.
Full protocol in Spanish, available upon request
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Asthma
  • Obstructive Sleep Apnea Syndrome
Device: CPAP
Continuous positive airways pressure (CPAP)
Other Name: Brand names will be added during fieldwork
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
Intervention: Device: CPAP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
120
Same as current
December 2013
December 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01374932
The CPASMA trial
No
Not Provided
Not Provided
Dr. Joan B Soriano, Cimera
Cimera
Not Provided
Principal Investigator: Jose Serrano, MD Hospital de Inca
Cimera
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP