Cystic Fibrosis (CF)NCT07903792
Diagnostic Value of Oropharyngeal Suction and Effect of Respiratory Physiotherapy on the Detection of Microorganisms in the Pediatric Patient
A study testing Respiratory physiothperapy, Oropharyngeal suction and Oropharyngeal swab in people with Cystic Fibrosis (CF) and Bronchiectasis, Non-Cystic Fibrosis, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
The goal of this clinical trial is to determine the effectiveness of oropharyngeal suction in detecting microorganisms by comparing it with induced sputum and oropharyngeal swab samples. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cystic Fibrosis (CF), Bronchiectasis, Non-Cystic Fibrosis
- What is being tested?
- Respiratory physiothperapy, Oropharyngeal suction and Oropharyngeal swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Having a chronic respiratory disease that requires sputum sample collection.
- Being able to cooperate during the physiotherapy session.
- Having provided signed informed consent.
Who cannot join
- Severe acute infection that contraindicates any of the procedures (e.g., severe respiratory failure, shock, etc.).
- Having taken antibiotics in the previous week, except for patients receiving chronic azithromycin treatment.
- Decompensated cardiorespiratory disease.
- History of severe adverse reactions to hypertonic saline nebulization.
- Patients who do not consent to or are unable to undergo the procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, 08208
Alba Valls-Llovera, +34644253942, avallsl@tauli.cat
About this study
Official title: Diagnostic Value of Oropharyngeal Suction Compared With Induced Sputum and Oropharyngeal Swab, and the Effect of Respiratory Physiotherapy on the Detection of Microorganisms in Paediatric Patients With Chronic Respiratory Disease: a Randomized Clinical Trial
The goal of this clinical trial is to determine the effectiveness of oropharyngeal suction in detecting microorganisms by comparing it with induced sputum and oropharyngeal swab samples. It also aims to assess the effect of respiratory physiotherapy on improving the results obtained in children aged 5-18 years with chronic lung disease.
The main questions it aims to answer are:
Read more
- What is the diagnostic efficacy of oropharyngeal suction in detecting microorganisms compared with induced sputum?
- What is the effect of undergoing a physiotherapy session before sample collection?
- How do the results obtained from oropharyngeal suction correlate with those obtained from oropharyngeal swabs?
- How does the age of the participants affect the results obtained from each sampling technique and the effect of prior physiotherapy?
- Are these techniques safe?
Researchers will compare samples collected after a physiotherapy session with those collected without prior physiotherapy to determine whether physiotherapy improves culture results.
Participants will be randomized into two groups: one group will undergo a physiotherapy session before sample collection, while the other will not. Three samples will be collected from each participant using oropharyngeal suction, an oropharyngeal swab, and induced sputum. Each participant may take part on multiple occasions, provided that at least one month has elapsed since their previous participation. On each occasion, participants will be randomized again.
Read the detailed description
Oropharyngeal suction (OPS) is a technique used to obtain respiratory samples from children with chronic respiratory diseases who have difficulty expectorating. However, its diagnostic performance has not been sufficiently compared with that of other sampling techniques commonly used in clinical practice, such as induced sputum (IS) and oropharyngeal swab (OS).
Induced sputum is a recommended comparator for evaluating respiratory sampling techniques in patients who have difficulty producing sputum spontaneously. This study will compare the results obtained using OPS with those obtained using IS and OS to assess the agreement between these methods in detecting respiratory microorganisms.
In addition, the effect of respiratory physiotherapy prior to sample collection has not been sufficiently investigated in this population. Respiratory physiotherapy promotes the mobilization and clearance of airway secretions and may improve sample quality and increase the detection of respiratory pathogens.
This study aims to assess the diagnostic performance of OPS compared with IS and OS and to determine whether respiratory physiotherapy prior to sample collection improves the detection of respiratory microorganisms in children with chronic respiratory diseases. An exploratory analysis will also investigate potential differences between age subgroups (5-11 years and 12-18 years).
Study Design This is a randomized, controlled clinical trial with two parallel groups. Participants will be randomized to undergo respiratory physiotherapy before sample collection or to undergo sample collection without prior respiratory physiotherapy.
Primary Objective To assess the diagnostic performance of OPS for detecting microorganisms by comparing the results with those obtained from IS, used as the reference comparator.
Secondary Objectives To assess the agreement between OPS and OS in detecting respiratory microorganisms; to evaluate whether respiratory physiotherapy prior to sample collection improves microorganism detection; to compare the results obtained using the different sampling techniques; to explore whether the diagnostic performance of the sampling techniques and the effect of respiratory physiotherapy differ between age subgroups (5-11 years and 12-17 years); and to assess the safety and tolerability of the sampling procedures.
Study Procedures and Intervention Participants will undergo sample collection using three consecutive sampling procedures: oropharyngeal swab (OS), oropharyngeal suction (OPS), and induced sputum (IS).
Participants will be randomized to one of two groups. In the intervention group, a respiratory physiotherapy session will be performed before sample collection. In the control group, samples will be collected without a prior respiratory physiotherapy session.
If a participant is unable to expectorate a sputum sample following the induced sputum procedure, oropharyngeal suction will be repeated. In these cases, the sampling sequence will consist of OS, OPS, and a second OPS procedure following induced sputum (OPS_postIS).
All samples will be processed according to standard laboratory protocols. Laboratory personnel responsible for processing and analysing the samples will remain blinded to the intervention allocation.
Culture results will be compared across the different sampling techniques, focusing on the presence or absence of microorganisms.
Participants may take part in more than one study visit, provided that at least one month has elapsed since their previous participation. Randomization will be performed again at each participation, according to the study protocol.
Study Population The study population will consist of children aged 5-18 years with chronic respiratory diseases who require sputum sampling for microbiological culture and are followed by the Paediatric Pulmonology Unit at Hospital Taulí, Sabadell, Spain.
Eligible conditions include cystic fibrosis (CF), non-cystic fibrosis bronchiectasis (NCFB), protracted bacterial bronchitis (PBB), and recurrent pneumonia.
Statistical Analysis Descriptive statistics will be used to summarize the study data. Quantitative variables will be described using means and standard deviations or medians and interquartile ranges, as appropriate. Categorical variables will be summarized using frequencies and percentages.
The diagnostic performance of OPS will be assessed by comparing its culture results with those obtained from IS. Sensitivity, specificity, and positive and negative predictive values will be calculated where appropriate. Agreement between sampling methods will be evaluated using Cohen's kappa coefficient with 95% confidence intervals, using IS as the reference comparator.
Exploratory subgroup analyses will investigate potential differences between children aged 5-11 years and those aged 12-18 years. The effect of respiratory physiotherapy on microorganism detection will also be assessed by comparing the results between the randomized groups.
The statistical significance level will be set at 0.05.
Safety Assessment Adverse events occurring during the sample collection procedures will be recorded to assess the safety and tolerability of the sampling techniques and the respiratory physiotherapy intervention.
- Being tested
- Respiratory physiothperapy, Oropharyngeal suction, Oropharyngeal swab, Induced Sputum
- Keywords
- Cystic Fibrosis, Bronchiectasis, Bacterial, Sputum culture, Orofaringeal swab, Respiratory physiotherapy, Oropharyngeal suction, induced sputum
- Medical subject headings
- Cystic Fibrosis, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory physiothperapyOther
It has not been studied whether carrying out a respiratory physiotherapy session prior to sampling improves the diagnostic performance of the different methods.
Oropharyngeal suctionOther
Sterile aspiration of the oropharyngeal area to collect mucus.
Oropharyngeal swabOther
Sterile swab of the oropharyngeal area to collect mucus.
Induced SputumOther
Collection of expectorated sputum after a 15-minute nebulization with a 4.5% hypertonic saline solution
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy group | Experimental | Participants will undergo a physiotherapy session before sample collection, consisting of inspiratory exercises and airway clearance techniques. Following the session, three samples will be collected: oropharyngeal swap, oropharyngeal suction, and induced sputum. Receives: Other: Respiratory physiothperapy; Other: Oropharyngeal suction; Other: Oropharyngeal swab; Other: Induced Sputum |
| Non-Physiotherapy group | Other | Three samples will be collected: oropharyngeal swab, oropharyngeal suction, and induced sputum. Receives: Other: Oropharyngeal suction; Other: Oropharyngeal swab; Other: Induced Sputum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/absence of microorganisms in each sample, as a binary variable
To determine the diagnostic efficacy of oropharyngeal suction, the detection of the studied microorganisms in the samples obtained using this method will be evaluated as a binary variable (presence/absence). The microorganisms studied are:
- Staphylococcus aureus, methicillin-sensitive (MSSA) and methicillin-resistant (MRSA)
- Pseudomonas aeruginosa (PA)
- Haemophilus influenzae (HI)
- Streptococcus pneumoniae (SP)
- Enterobacter cloacae (EC)
- Burkholderia cepacia (BC)
- Moraxella catarrhalis (MC)
- Mycobacterium abscessus (MA)
- Aspergillus fumigatus (AF)
- Other
From these variables, the following derived indicators will be obtained:
- Suction vs. induced sputum agreement (percentage agreement and kappa coefficient)
- Suction sensitivity
- Suction specificity
Measured: At baseline
Secondary outcomes (7)
Presence/absence of microorganisms in Oropharyngeal Suction and Induced Sputum obtained post-physiotherapy
To determine the effect of a physiotherapy session prior to sample collection, the presence/absence of the studied microorganisms in samples obtained by suction and those obtained through induced sputum will be evaluated.
The following derived indicators will be compared with those of the group that has NOT undergone prior physiotherapy to determine whether this improves the agreement between the methods:
- Suction and induced sputum agreement by group (κ and % agreement)
- Sensitivity and specificity stratified by group
Measured: At baseline
Presence/absence of microorganisms in oropharyngeal swab and oropharyngeal suction
To compare the results obtained from samples collected by oropharyngeal swab and those obtained by oropharyngeal suction, the presence or absence of the microorganisms studied will be determined in both samples. The degree of agreement will be calculated as a derived indicator (κ and percentage of agreement).
Measured: At baseline
Sensitivity and specificity of oropharyngeal suction and oropharyngeal swab compared to induced sputum
It will be determined by the proportions of true positives and true negatives, respectively, relative to induced sputum, which is considered the reference method.
Measured: At baseline
Age
Quantitative variable (years), which will be categorized into two subgroups for analysis: children (5-11 years) and adolescents (12-18 years). It will be used as a potential effect modifier in the analysis of diagnostic concordance and response to respiratory physiotherapy.
Measured: At baseline
Oxygen saturation
Oxygen saturation (as a percentage) to determine safety of the three sample taking methods.
Measured: Before and immediately after the procedure
Heart rate
Heart rate (in beats per minute) will be recorded before and after sample collection to determine the safety of each technique.
Measured: Before and immediately after the procedure
Presence/absence of adverse effects
The presence or absence of the following adverse effects will be recorded both during sample collection and on the following day:
- Irritative/persistent cough
- Vomiting
- Nausea
- Other (specify)
Measured: During the procedure and up to 24 hours post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis (CF)Studies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The same participant may be included multiple times, provided that at least one month has elapsed since their previous sample collection. At each inclusion, the participant will be randomized again to one of the study groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alba Valls-Llovera, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903792
- Sponsor's protocol ID
- 2026.020-30
- Other IDs
- CIR2025028
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Marguet C, Houdouin V, Pin I, Reix P, Huet F, Mittaine M, Ramel S, Wizla-Derambure N, Abely M, Dalphin ML, Fayon M, Bihouee T, Le Bourgeois M, Deneuville E, Corvol H, Laurans M, Couderc L, Leroux E, Lemee L. Chest physiotherapy enhances detection of Pseudomonas aeruginosa in nonexpectorating children with cystic fibrosis. ERJ Open Res. 2021 Mar 8;7(1):00513-2020. doi: 10.1183/23120541.00513-2020. eCollection 2021 Jan.
PubMed 33718497Avital A, Uwyyed K, Picard E, Godfrey S, Springer C. Sensitivity and specificity of oropharyngeal suction versus bronchoalveolar lavage in identifying respiratory tract pathogens in children with chronic pulmonary infection. Pediatr Pulmonol. 1995 Jul;20(1):40-3. doi: 10.1002/ppul.1950200108.
PubMed 7478780Doumit M, Belessis Y, Stelzer-Braid S, Mallitt KA, Rawlinson W, Jaffe A. Diagnostic accuracy and distress associated with oropharyngeal suction in cystic fibrosis. J Cyst Fibros. 2016 Jul;15(4):473-8. doi: 10.1016/j.jcf.2015.09.001. Epub 2015 Sep 18.
PubMed 26388518Wang L, Yang S, Yan X, Liu T, Feng Z, Li G. Comparing the yield of oropharyngeal swabs and sputum for detection of 11 common pathogens in hospitalized children with lower respiratory tract infection. Virol J. 2019 Jun 24;16(1):84. doi: 10.1186/s12985-019-1177-x.
PubMed 31234918Serigstad S, Knoop ST, Markussen DL, Ulvestad E, Bjorneklett RO, Ebbesen MH, Kommedal O, Grewal HMS. Diagnostic utility of oropharyngeal swabs as an alternative to lower respiratory tract samples for PCR-based syndromic testing in patients with community-acquired pneumonia. J Clin Microbiol. 2023 Sep 21;61(9):e0050523. doi: 10.1128/jcm.00505-23. Epub 2023 Aug 16.
PubMed 37585220Zampoli M, Pillay K, Carrara H, Zar HJ, Morrow B. Microbiological yield from induced sputum compared to oropharyngeal swab in young children with cystic fibrosis. J Cyst Fibros. 2016 Sep;15(5):605-10. doi: 10.1016/j.jcf.2016.01.001. Epub 2016 Jan 26.
PubMed 26825010Eyns H, Pierard D, De Wachter E, Eeckhout L, Vaes P, Malfroot A. Respiratory Bacterial Culture Sampling in Expectorating and Non-expectorating Patients With Cystic Fibrosis. Front Pediatr. 2018 Dec 18;6:403. doi: 10.3389/fped.2018.00403. eCollection 2018.
PubMed 30619797Wang H, Li X, Zheng Y, Verhagen LM, Gu J, Li L, Xu Z, Wang W, de Jonge MI. Concordance in pathogen identification at the upper and lower respiratory tract of children with severe pneumonia. BMC Infect Dis. 2023 Mar 20;23(1):170. doi: 10.1186/s12879-023-08127-w.
PubMed 36941581Prevaes SM, de Steenhuijsen Piters WA, de Winter-de Groot KM, Janssens HM, Tramper-Stranders GA, Chu ML, Tiddens HA, van Westreenen M, van der Ent CK, Sanders EA, Bogaert D. Concordance between upper and lower airway microbiota in infants with cystic fibrosis. Eur Respir J. 2017 Mar 29;49(3):1602235. doi: 10.1183/13993003.02235-2016. Print 2017 Mar.
PubMed 28356374Fenn D, Abdel-Aziz MI, Brinkman P, Kos R, Neerincx AH, Altenburg J, Weersink E, Haarman EG, Terheggen-Lagro SWJ, Maitland-van der Zee AH, Bos LDJ; Amsterdam mucociliary clearance disease research group. Comparison of microbial composition of cough swabs and sputum for pathogen detection in patients with cystic fibrosis. J Cyst Fibros. 2022 Jan;21(1):52-60. doi: 10.1016/j.jcf.2021.08.031. Epub 2021 Sep 20.
PubMed 34548223Ronchetti K, Tame JD, Paisey C, Thia LP, Doull I, Howe R, Mahenthiralingam E, Forton JT. The CF-Sputum Induction Trial (CF-SpIT) to assess lower airway bacterial sampling in young children with cystic fibrosis: a prospective internally controlled interventional trial. Lancet Respir Med. 2018 Jun;6(6):461-471. doi: 10.1016/S2213-2600(18)30171-1. Epub 2018 May 16.
PubMed 29778403Dubourg G, Abat C, Rolain JM, Raoult D. Correlation between sputum and bronchoalveolar lavage fluid cultures. J Clin Microbiol. 2015 Mar;53(3):994-6. doi: 10.1128/JCM.02918-14. Epub 2014 Dec 24.
PubMed 25540405Blau H, Linnane B, Carzino R, Tannenbaum EL, Skoric B, Robinson PJ, Robertson C, Ranganathan SC. Induced sputum compared to bronchoalveolar lavage in young, non-expectorating cystic fibrosis children. J Cyst Fibros. 2014 Jan;13(1):106-10. doi: 10.1016/j.jcf.2013.05.013. Epub 2013 Jun 24.
PubMed 23806622Luo W, Lin Y, Li Z, Wang W, Shi Y. Comparison of sputum induction and bronchoscopy in diagnosis of sputum smear-negative pulmonary tuberculosis: a systemic review and meta-analysis. BMC Pulm Med. 2020 May 25;20(1):146. doi: 10.1186/s12890-020-01192-w.
PubMed 32450826Ogawa M, Hoshina T, Abushawish A, Kusuhara K. Evaluation of the usefulness of culture of induced sputum and the optimal timing for the collection of a good-quality sputum sample to identify causative pathogen of community-acquired pneumonia in young children: A prospective observational study. J Microbiol Immunol Infect. 2023 Oct;56(5):1036-1044. doi: 10.1016/j.jmii.2023.05.005. Epub 2023 Jun 2.
PubMed 37302895
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Oropharyngeal Suction Compared With Induced Sputum and Oropharyngeal Swab, and the Effect of Respiratory Physiotherapy on the Detection of Microorganisms in Paediatric Patients With Chronic Respiratory Disease: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07903792
- Acronym / sponsor ID
- 2026.020-30
- Keywords
- Cystic Fibrosis, Bronchiectasis, Bacterial, Sputum culture, Orofaringeal swab, Respiratory physiotherapy, Oropharyngeal suction, induced sputum
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 29 Oct 2026 (actual)
- 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 goal of this clinical trial is to determine the effectiveness of oropharyngeal suction in detecting microorganisms by comparing it with induced sputum and oropharyngeal swab samples. It also aims to assess the effect of respiratory physiotherapy on improving the results obtained in children aged 5-18 years with chronic lung disease.
The main questions it aims to answer are:
- What is the diagnostic efficacy of oropharyngeal suction in detecting microorganisms compared with induced sputum?
- What is the effect of undergoing a physiotherapy session before sample collection?
- How do the results obtained from oropharyngeal suction correlate with those obtained from oropharyngeal swabs?
- How does the age of the participants affect the results obtained from each sampling technique and the effect of prior physiotherapy?
- Are these techniques safe?
Researchers will compare samples collected after a physiotherapy session with those collected without prior physiotherapy to determine whether physiotherapy improves culture results.
Participants will be randomized into two groups: one group will undergo a physiotherapy session before sample collection, while the other will not. Three samples will be collected from each participant using oropharyngeal suction, an oropharyngeal swab, and induced sputum. Each participant may take part on multiple occasions, provided that at least one month has elapsed since their previous participation. On each occasion, participants will be randomized again.
Detailed description
Oropharyngeal suction (OPS) is a technique used to obtain respiratory samples from children with chronic respiratory diseases who have difficulty expectorating. However, its diagnostic performance has not been sufficiently compared with that of other sampling techniques commonly used in clinical practice, such as induced sputum (IS) and oropharyngeal swab (OS).
Induced sputum is a recommended comparator for evaluating respiratory sampling techniques in patients who have difficulty producing sputum spontaneously. This study will compare the results obtained using OPS with those obtained using IS and OS to assess the agreement between these methods in detecting respiratory microorganisms.
In addition, the effect of respiratory physiotherapy prior to sample collection has not been sufficiently investigated in this population. Respiratory physiotherapy promotes the mobilization and clearance of airway secretions and may improve sample quality and increase the detection of respiratory pathogens.
This study aims to assess the diagnostic performance of OPS compared with IS and OS and to determine whether respiratory physiotherapy prior to sample collection improves the detection of respiratory microorganisms in children with chronic respiratory diseases. An exploratory analysis will also investigate potential differences between age subgroups (5-11 years and 12-18 years).
Study Design This is a randomized, controlled clinical trial with two parallel groups. Participants will be randomized to undergo respiratory physiotherapy before sample collection or to undergo sample collection without prior respiratory physiotherapy.
Primary Objective To assess the diagnostic performance of OPS for detecting microorganisms by comparing the results with those obtained from IS, used as the reference comparator.
Secondary Objectives To assess the agreement between OPS and OS in detecting respiratory microorganisms; to evaluate whether respiratory physiotherapy prior to sample collection improves microorganism detection; to compare the results obtained using the different sampling techniques; to explore whether the diagnostic performance of the sampling techniques and the effect of respiratory physiotherapy differ between age subgroups (5-11 years and 12-17 years); and to assess the safety and tolerability of the sampling procedures.
Study Procedures and Intervention Participants will undergo sample collection using three consecutive sampling procedures: oropharyngeal swab (OS), oropharyngeal suction (OPS), and induced sputum (IS).
Participants will be randomized to one of two groups. In the intervention group, a respiratory physiotherapy session will be performed before sample collection. In the control group, samples will be collected without a prior respiratory physiotherapy session.
If a participant is unable to expectorate a sputum sample following the induced sputum procedure, oropharyngeal suction will be repeated. In these cases, the sampling sequence will consist of OS, OPS, and a second OPS procedure following induced sputum (OPS_postIS).
All samples will be processed according to standard laboratory protocols. Laboratory personnel responsible for processing and analysing the samples will remain blinded to the intervention allocation.
Culture results will be compared across the different sampling techniques, focusing on the presence or absence of microorganisms.
Participants may take part in more than one study visit, provided that at least one month has elapsed since their previous participation. Randomization will be performed again at each participation, according to the study protocol.
Study Population The study population will consist of children aged 5-18 years with chronic respiratory diseases who require sputum sampling for microbiological culture and are followed by the Paediatric Pulmonology Unit at Hospital Taulí, Sabadell, Spain.
Eligible conditions include cystic fibrosis (CF), non-cystic fibrosis bronchiectasis (NCFB), protracted bacterial bronchitis (PBB), and recurrent pneumonia.
Statistical Analysis Descriptive statistics will be used to summarize the study data. Quantitative variables will be described using means and standard deviations or medians and interquartile ranges, as appropriate. Categorical variables will be summarized using frequencies and percentages.
The diagnostic performance of OPS will be assessed by comparing its culture results with those obtained from IS. Sensitivity, specificity, and positive and negative predictive values will be calculated where appropriate. Agreement between sampling methods will be evaluated using Cohen's kappa coefficient with 95% confidence intervals, using IS as the reference comparator.
Exploratory subgroup analyses will investigate potential differences between children aged 5-11 years and those aged 12-18 years. The effect of respiratory physiotherapy on microorganism detection will also be assessed by comparing the results between the randomized groups.
The statistical significance level will be set at 0.05.
Safety Assessment Adverse events occurring during the sample collection procedures will be recorded to assess the safety and tolerability of the sampling techniques and the respiratory physiotherapy intervention.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The same participant may be included multiple times, provided that at least one month has elapsed since their previous sample collection. At each inclusion, the participant will be randomized again to one of the study groups.
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy group | Experimental | Other: Respiratory physiothperapy, Other: Oropharyngeal suction, Other: Oropharyngeal swab, Other: Induced SputumParticipants will undergo a physiotherapy session before sample collection, consisting of inspiratory exercises and airway clearance techniques. Following the session, three samples will be collected: oropharyngeal swap, oropharyngeal suction, and induced sputum. |
| Non-Physiotherapy group | Other | Other: Oropharyngeal suction, Other: Oropharyngeal swab, Other: Induced SputumThree samples will be collected: oropharyngeal swab, oropharyngeal suction, and induced sputum. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Having a chronic respiratory disease that requires sputum sample collection.
- Being able to cooperate during the physiotherapy session.
- Having provided signed informed consent.
Key exclusion criteria (5 listed)
- Severe acute infection that contraindicates any of the procedures (e.g., severe respiratory failure, shock, etc.).
- Having taken antibiotics in the previous week, except for patients receiving chronic azithromycin treatment.
- Decompensated cardiorespiratory disease.
- History of severe adverse reactions to hypertonic saline nebulization.
- Patients who do not consent to or are unable to undergo the procedures.
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 |
|---|---|---|
| Respiratory physiothperapyIt has not been studied whether carrying out a respiratory physiotherapy session prior to sampling improves the diagnostic performance of the different methods. | Other | Physiotherapy group |
| Oropharyngeal suctionSterile aspiration of the oropharyngeal area to collect mucus. | Other | Non-Physiotherapy group, Physiotherapy group |
| Oropharyngeal swabSterile swab of the oropharyngeal area to collect mucus. | Other | Non-Physiotherapy group, Physiotherapy group |
| Induced SputumCollection of expectorated sputum after a 15-minute nebulization with a 4.5% hypertonic saline solution | Other | Non-Physiotherapy group, Physiotherapy group |
Primary outcome
Presence/absence of microorganisms in each sample, as a binary variable
Time frame: At baseline
To determine the diagnostic efficacy of oropharyngeal suction, the detection of the studied microorganisms in the samples obtained using this method will be evaluated as a binary variable (presence/absence). The microorganisms studied are: * Staphylococcus aureus, methicillin-sensitive (MSSA) and methicillin-resistant (MRSA) * Pseudomonas aeruginosa (PA) * Haemophilus influenzae (HI) * Streptococcus pneumoniae (SP) * Enterobacter cloacae (EC) * Burkholderia cepacia (BC) * Moraxella catarrhalis (MC) * Mycobacterium abscessus (MA) * Aspergillus fumigatus (AF) * Other From these variables, the following derived indicators will be obtained: * Suction vs. induced sputum agreement (percentage agreement and kappa coefficient) * Suction sensitivity * Suction specificity
7 secondary outcomes
Presence/absence of microorganisms in Oropharyngeal Suction and Induced Sputum obtained post-physiotherapy
Time frame: At baseline
Presence/absence of microorganisms in oropharyngeal swab and oropharyngeal suction
Time frame: At baseline
Sensitivity and specificity of oropharyngeal suction and oropharyngeal swab compared to induced sputum
Time frame: At baseline
Age
Time frame: At baseline
Oxygen saturation
Time frame: Before and immediately after the procedure
Heart rate
Time frame: Before and immediately after the procedure
Presence/absence of adverse effects
Time frame: During the procedure and up to 24 hours post-procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 33718497Marguet C, Houdouin V, Pin I, Reix P, Huet F, Mittaine M, Ramel S, Wizla-Derambure N, Abely M, Dalphin ML, Fayon M, Bihouee T, Le Bourgeois M, Deneuville E, Corvol H, Laurans M, Couderc L, Leroux E, Lemee L. Chest physiotherapy enhances detection of Pseudomonas aeruginosa in nonexpectorating children with cystic fibrosis. ERJ Open Res. 2021 Mar 8;7(1):00513-2020. doi: 10.1183/23120541.00513-2020. eCollection 2021 Jan.
- Background: PubMed 7478780Avital A, Uwyyed K, Picard E, Godfrey S, Springer C. Sensitivity and specificity of oropharyngeal suction versus bronchoalveolar lavage in identifying respiratory tract pathogens in children with chronic pulmonary infection. Pediatr Pulmonol. 1995 Jul;20(1):40-3. doi: 10.1002/ppul.1950200108.
- Background: PubMed 26388518Doumit M, Belessis Y, Stelzer-Braid S, Mallitt KA, Rawlinson W, Jaffe A. Diagnostic accuracy and distress associated with oropharyngeal suction in cystic fibrosis. J Cyst Fibros. 2016 Jul;15(4):473-8. doi: 10.1016/j.jcf.2015.09.001. Epub 2015 Sep 18.
- Background: PubMed 31234918Wang L, Yang S, Yan X, Liu T, Feng Z, Li G. Comparing the yield of oropharyngeal swabs and sputum for detection of 11 common pathogens in hospitalized children with lower respiratory tract infection. Virol J. 2019 Jun 24;16(1):84. doi: 10.1186/s12985-019-1177-x.
- Background: PubMed 37585220Serigstad S, Knoop ST, Markussen DL, Ulvestad E, Bjorneklett RO, Ebbesen MH, Kommedal O, Grewal HMS. Diagnostic utility of oropharyngeal swabs as an alternative to lower respiratory tract samples for PCR-based syndromic testing in patients with community-acquired pneumonia. J Clin Microbiol. 2023 Sep 21;61(9):e0050523. doi: 10.1128/jcm.00505-23. Epub 2023 Aug 16.
- Background: PubMed 26825010Zampoli M, Pillay K, Carrara H, Zar HJ, Morrow B. Microbiological yield from induced sputum compared to oropharyngeal swab in young children with cystic fibrosis. J Cyst Fibros. 2016 Sep;15(5):605-10. doi: 10.1016/j.jcf.2016.01.001. Epub 2016 Jan 26.
- Background: PubMed 30619797Eyns H, Pierard D, De Wachter E, Eeckhout L, Vaes P, Malfroot A. Respiratory Bacterial Culture Sampling in Expectorating and Non-expectorating Patients With Cystic Fibrosis. Front Pediatr. 2018 Dec 18;6:403. doi: 10.3389/fped.2018.00403. eCollection 2018.
- Background: PubMed 36941581Wang H, Li X, Zheng Y, Verhagen LM, Gu J, Li L, Xu Z, Wang W, de Jonge MI. Concordance in pathogen identification at the upper and lower respiratory tract of children with severe pneumonia. BMC Infect Dis. 2023 Mar 20;23(1):170. doi: 10.1186/s12879-023-08127-w.
- Background: PubMed 28356374Prevaes SM, de Steenhuijsen Piters WA, de Winter-de Groot KM, Janssens HM, Tramper-Stranders GA, Chu ML, Tiddens HA, van Westreenen M, van der Ent CK, Sanders EA, Bogaert D. Concordance between upper and lower airway microbiota in infants with cystic fibrosis. Eur Respir J. 2017 Mar 29;49(3):1602235. doi: 10.1183/13993003.02235-2016. Print 2017 Mar.
- Background: PubMed 34548223Fenn D, Abdel-Aziz MI, Brinkman P, Kos R, Neerincx AH, Altenburg J, Weersink E, Haarman EG, Terheggen-Lagro SWJ, Maitland-van der Zee AH, Bos LDJ; Amsterdam mucociliary clearance disease research group. Comparison of microbial composition of cough swabs and sputum for pathogen detection in patients with cystic fibrosis. J Cyst Fibros. 2022 Jan;21(1):52-60. doi: 10.1016/j.jcf.2021.08.031. Epub 2021 Sep 20.
- Background: PubMed 29778403Ronchetti K, Tame JD, Paisey C, Thia LP, Doull I, Howe R, Mahenthiralingam E, Forton JT. The CF-Sputum Induction Trial (CF-SpIT) to assess lower airway bacterial sampling in young children with cystic fibrosis: a prospective internally controlled interventional trial. Lancet Respir Med. 2018 Jun;6(6):461-471. doi: 10.1016/S2213-2600(18)30171-1. Epub 2018 May 16.
- Background: PubMed 25540405Dubourg G, Abat C, Rolain JM, Raoult D. Correlation between sputum and bronchoalveolar lavage fluid cultures. J Clin Microbiol. 2015 Mar;53(3):994-6. doi: 10.1128/JCM.02918-14. Epub 2014 Dec 24.
- Individual participant dataSharing planned: Undecided
Related trials for Cystic Fibrosis (CF)
Active, not recruiting
Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis
Cystic Fibrosis (CF)
RecruitingObservational study
TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age
Cystic Fibrosis (CF)
Active, not recruitingObservational study
Genetic Modifiers of Cystic Fibrosis (CF) Liver Disease
Cystic Fibrosis, Liver Disease
Recruiting
Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 2
Phase 2 Study to Assess the Safety and Efficacy of ANG003
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory physiothperapy, Oropharyngeal suction and Oropharyngeal swab in people with Cystic Fibrosis (CF) and Bronchiectasis, Non-Cystic Fibrosis, run by Corporacion Parc Tauli at 1 site 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 3 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: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alba Valls-Llovera (+34644253942, avallsl@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence/absence of microorganisms in each sample, as a binary variable (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07903792, which also lists 20 linked publications.
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 29 Oct 2026.