Clinical trial NCT01854788: 3 Airway Clearance Techniques in Non Cystic Fibrosis Bronchiectasis
Official title: A Comparative Study of Three Airway Clearance Techniques With Different Autonomy Degrees in Non Cystic Fibrosis Bronchiectasis: Randomized Cross-over Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiectasis
Keywords: Airway clearance techniques
Mucus clearance
Chest physiotherapy
Autogenic drainage
Slow expiration with glottis opened in lateral posture(ELTGOL)
Temporary-positive expiratory pressure (T-PEP)
Non cystic fibrosis bronchiectasis
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study design: a randomized, crossover trial. Each patient performed three different airway clearance techniques (Autogenic drainage, slow expiratory with glottis opened in lateral posture \[ELTGOL\], temporary- positive expiratory pressure \[T-PEP\] with not similar autonomy degree in a randomized order. Each technique were applied in 3 sessions during one week at alternate days (Monday /Wednesday/Friday or Tuesday/Thursday/Saturday). The time spent in each bronchial session was 40 minutes. Seven days were the wash-out time period between the different techniques.


Eligibility criteria: Inclusion Criteria:

1. - Non Cystic Fibrosis bronchiectasis diagnosed by High Resolution Computed Tomographic
2. - Mean sputum production ≥ 15 ml /24h
3. - Clinical stability in the last 6 weeks
4. - Not carrying out regular chest physiotherapy
5. - Forced expiratory volume in 1 second ≥ 30% pred. ; Forced Vital Capacity ≥ 45% pred. and peak expiratory flow \>270 L/s

Exclusion Criteria:

1. - Smoker or non-smoker form less than 2 years
2. - Cystic fibrosis
3. - Active tuberculosis or sarcoidosis

Primary outcomes:
measure: Weight of sputum expectorated during each airway clearance therapy session
timeFrame: 40 minutes
measure: Weight of sputum expectorated 24 hours post each bronchial session
timeFrame: 24 hours
Secondary outcomes:
measure: Saint George Respiratory Questionnaire (SGRQ)
timeFrame: Change from baseline at 5 weeks
measure: Leicester Cough Questionnaire (LCQ)
timeFrame: Changes from baseline arm to 1 week
Other outcomes:
measure: Lung function measured by simple spirometry: forced expiratory volume in 1 second, Forced vital capacity, Forced expiratory flow 25-75
timeFrame: Change from baseline arm to 1 week
measure: Likert test
timeFrame: Change from baseline arm to 1 week
Locations:
city: Barcelona
country: Spain
facility: Hospital CLinic
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Beatriz Herrero, Phy
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Eva Polverino, Doctor
role: STUDY_DIRECTOR
References:
citation: Herrero-Cortina B, Alcaraz-Serrano V, Torres A, Polverino E. Reliability and Minimum Important Difference of Sputum Weight in Bronchiectasis. Respir Care. 2020 Oct;65(10):1478-1487. doi: 10.4187/respcare.07175. Epub 2020 Feb 18.
citation: Herrero-Cortina B, Vilaro J, Marti D, Torres A, San Miguel-Pagola M, Alcaraz V, Polverino E. Short-term effects of three slow expiratory airway clearance techniques in patients with bronchiectasis: a randomised crossover trial. Physiotherapy. 2016 Dec;102(4):357-364. doi: 10.1016/j.physio.2015.07.005. Epub 2015 Dec 1.