CPASMA: Is There an Improvement in Asthma in Patients With Both Asthma and OSAS Treated With CPAP?
This study is currently recruiting participants.
Verified June 2012 by Cimera
Sponsor:
Cimera
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
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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
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 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 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:
|
Apnea Asthma Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Bronchial Diseases Lung Diseases, Obstructive |
Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013