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Non Invasive Ventilation as Airway Clearance in Patients With Cystic Fibrosis

NCT ID: NCT02083263

Last Updated: 2014-07-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-09-30

Brief Summary

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With the use of Non invasive ventilation the patients with cystic fibrosis will have better lung function (FEV1).

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Detailed Description

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3 months intervention between PEP an Bilevel. The patients will follow up under 3 months.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bilevel

Bilevel, 3 months. The treatment was performed twice a day, 1 hour each treatment.

Group Type EXPERIMENTAL

Bilevel

Intervention Type DEVICE

3 months

PEP mask

PEP mask, 3 months. The treatment was performed twice a day, 1 hour each treatment.

Group Type ACTIVE_COMPARATOR

PEP mask

Intervention Type DEVICE

3 months

Interventions

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Bilevel

3 months

Intervention Type DEVICE

PEP mask

3 months

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with CF older than 18 years
* FEV1 between 20% and 69% of predictive.
* No acute exacerbation.
* No Burkhordelia Cepacia/MRSA colonization.

Exclusion Criteria

* Children under 18 year
* acute exacerbation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Cecilia Rodriguez

Specialist Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cecilia Rodriguez, Physio

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Cecilia Rodriguez

Stockholm, Stockholm County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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CF2012-1

Identifier Type: -

Identifier Source: org_study_id

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