AsthmaPhase 3CPASMANCT01374932
CPASMA: Is There an Improvement in Asthma in Patients With Both Asthma and OSAS Treated With CPAP?
A Phase 3 study testing CPAP in people with Asthma and Obstructive Sleep Apnea Syndrome, run by Cimera at 10 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma, Obstructive Sleep Apnea Syndrome
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 10 sitesSpain
- Study dates
- Jul 2011to Dec 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 to 70 yrs.) with asthma who require treatment with CPAP because of OSAS (RDI> = 20 events per hour)
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
Joan B Soriano, MD contact
10 sites in 1 country
Spain10 sites, 10 recruiting
- Recruiting
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid
Soledad Alonso Viteri, MD
- Recruiting
Hospital de la Santa Creu i de Sant Pau
Barcelona
Vicente Plaza Moral, MD, vplaza@santpau.cat
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona
Merce Mayos Perez, MD
- Recruiting
Hospital de Jerez
Cadiz
José Gregorio Soto Campos, MD
- Recruiting
Hospital de Laredo
Cantabria.
Juan Luis García Rivero, MD
- Recruiting
Hospital comarcal de Inca
Inca, Balearic Islands
José Serrano, MD, jserrano@separ.es
José Serrano, MD
- Recruiting
Hospital Universitario Dr. Negrín
Las Palmas
Carlos Cabrera López, MD
- Recruiting
Hospital Moncloa
Madrid
Sagrario Mayoralas Alises, MD
- Recruiting
Hospital Universitario Puerta de Hierro
Madrid
Antolin Lopez Viña, MD, alopezv@separ.es
- Recruiting
Corporació Sanitària Parc Taulí
Sabadell
Ana Isabel Sogo Sagardia, MD
Laura Vigil Giménez., MD
About this study
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?
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.
Read the detailed description
Full protocol in Spanish, available upon request
- Conditions
- Asthma, Obstructive Sleep Apnea Syndrome
- Being tested
- CPAP
- Keywords
- Asthma, Obstructive Sleep Apnea Syndrome
- Medical subject headings
- Asthma, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Also called Brand names will be added during fieldwork
Continuous positive airways pressure (CPAP)
| Study group | Role | What they receive |
|---|---|---|
| CPAP (see below) | Experimental | 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 Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control questionnaire
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cimera
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Dr. Joan B Soriano, Cimera
- Investigators
- Jose Serrano, MD, Principal investigator, Hospital de Inca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374932
- Sponsor's protocol ID
- The CPASMA trial
- Acronym
- CPASMA
- Status last verified
- Jun 2012
- First submitted
- 30 May 2011
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT01374932
- Acronym / sponsor ID
- CPASMA / The CPASMA trial
- Conditions
- Asthma, Obstructive Sleep Apnea Syndrome
- Keywords
- Asthma, Obstructive Sleep Apnea Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- CimeraResearch network
- Study start
- Jul 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 16 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Full protocol in Spanish, available upon request
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP (see below) | Experimental | Device: CPAPAdult 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (18 to 70 yrs.) with asthma who require treatment with CPAP because of OSAS (RDI> = 20 events per hour)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPAlso: Brand names will be added during fieldworkContinuous positive airways pressure (CPAP) | Device | CPAP (see below) |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan B Soriano, MD contact
Jose Serrano, MD principal investigator
Hospital de Inca
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CPAP in people with Asthma and Obstructive Sleep Apnea Syndrome, run by Cimera at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact José Serrano, MD (+34-971888500 ext. 4020, jserrano@separ.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma control questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2012.