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

NCT ID: NCT01374932

Last Updated: 2012-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Full protocol in Spanish, available upon request

Conditions

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Asthma Obstructive Sleep Apnea Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

CPAP

Intervention Type DEVICE

Continuous positive airways pressure (CPAP)

Interventions

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CPAP

Continuous positive airways pressure (CPAP)

Intervention Type DEVICE

Other Intervention Names

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Brand names will be added during fieldwork

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cimera

NETWORK

Sponsor Role lead

Responsible Party

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Dr. Joan B Soriano

Programme Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jose Serrano, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Inca

Locations

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Hospital comarcal de Inca

Inca, Balearic Islands, Spain

Site Status RECRUITING

Hospital Universitario Príncipe de Asturias

Alcalá de Henares, Madrid, Spain

Site Status RECRUITING

Hospital de la Santa Creu i de Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Hospital de Jerez

Cadiz, , Spain

Site Status RECRUITING

Hospital de Laredo

Cantabria., , Spain

Site Status RECRUITING

Hospital Universitario Dr. Negrín

Las Palmas, , Spain

Site Status RECRUITING

Hospital Moncloa

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Puerta de Hierro

Madrid, , Spain

Site Status RECRUITING

Corporació Sanitària Parc Taulí

Sabadell, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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José Serrano, MD

Role: CONTACT

[email protected]
+34-971888500 ext. 4020

Joan B Soriano, MD

Role: CONTACT

[email protected]

Facility Contacts

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José Serrano, MD

Role: primary

[email protected]

Soledad Alonso Viteri, MD

Role: primary

Vicente Plaza Moral, MD

Role: primary

[email protected]

Merce Mayos Perez, MD

Role: primary

José Gregorio Soto Campos, MD

Role: primary

Juan Luis García Rivero, MD

Role: primary

Carlos Cabrera López, MD

Role: primary

Sagrario Mayoralas Alises, MD

Role: primary

Antolin Lopez Viña, MD

Role: primary

[email protected]

Ana Isabel Sogo Sagardia, MD

Role: primary

Other Identifiers

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The CPASMA trial

Identifier Type: -

Identifier Source: org_study_id

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