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CompletedNCT06086730Updated Dec 27, 2023

Comparison Of Blow Bottle Positive Expiratory Pressure (BBPEP) Versus Acapella Among Patient With Chronic Bronchitis

An interventional study of blow bottle positive expiratory pressure and acapella in Chronic Bronchitis, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-12-27.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
All
01

Study summary

Comparison of Blow Bottle Positive Expiratory pressure(BBPEP)versus acapella on Oxygenation ,peak Expiratory Flow Rate(PEFR)among patient with chronic bronchitis.

Read the detailed description

Worldwide most of the people belong to all age group may affected with Non communicable diseases(NCD) which leads them toward death globally . According to stats World Health Organization (WHO) declares about 41 million people are died due to NCD which means about 71 %people are died globally due to this .Chronic Respiratory diseases are one of the main non communicable disease . About 9.0 million(3.6%) adult belong to age group of 18 or older may suffer from chronic bronchitis . Hallmark of chronic bronchitis is that cough and sputum production for more than >3months in each of at least two connective years. Chronic bronchitis effects every third person having COPD but it may effect any body who had normal pulmonary functions. Now a days positive expiratory pressure (PEP)devices are used along Cardio Pulmonary Therapy(CPT) .PEP devices are help full in mobilize the secretion in lower respiratory tract , may also beneficial in collateral ventilation ,mucous secretion and most importantly optimize functional residual capacity among people who had pulmonary complications. Many PEP devices are available in market but BBPEP is in low cost and are easily in approach of every single person .PEP is non invasive technique used to improve clinical outcome .

In this study investigator compare the effect of BBPEP and Acapella in participant having chronic bronchitis .In case of BBPEP patient expires against resistance of water column which increase PEP ( positive expiratory pressure ) in inlet which transferred airway patients lungs this will keep the alveoli patent or may recruit the collapsed alveoli. This will decrease airway resistance and improve lung compliance . As airway resistance decreases the amount of SPO2 AND PEFR also improved . participant are randomly assigned into two different group GROUP(A) AND GROUP(B) Group (A) receive intervention by using BBPEP device along with deep breathing exercises group (B)participant use acapella devices so out come will be measured participant rotate the device toward positive(+) sign to increase resistance or may rotate device to minus (-) to decrease resistance participant is in comfortable short sitting position ask him to take deep breath and hold it for 3 sec nose clip attached to the participant participant lips sealed mouthpiece ask him to exhale into mouth piece maneuver repeated for 10 to 12 breath with 3 to 4 huffs all the steps repeated for 15 minute. study will be carried out for 8 weeks , 3 days per week. Outcome variables will be Peak flow meter , pulse oximeter ,casa q scale ,heart rate, respiratory rate blood pressure. Data will be analyzed on SPSS-25.

02

Conditions studied

  • Chronic Bronchitis

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Keywords

  • alveolar collapse,hypersecreation,airway obstruction
03

In context

Bronchitis, Chronic

209 studies on the registry are indexed under Bronchitis, Chronic; 14 are open to participants now.

This study's enrollment of 36 is below the median of 101 across 154 interventional studies indexed under Bronchitis, Chronic.

Browse Bronchitis, Chronic studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,193 studies on the registry; 650 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant having chronic bronchitis both male and female.
  • Presence of chronic bronchitis I-e daily cough and sputum production for at least 3 months each year during the past 2 years.
  • Current smoker or ex smoker with 5 packs years of smoking history.
  • Participant willing to participate.
  • Presence of air flow obstruction by spirometry(GOLD stage 2).
  • Participant with stable hemodynamic .

Exclusion criteria

Exclusion Criteria:

  • History of cough syncope.
  • participant who required intubation.
  • Participant who is critically ill.
  • Participant who required functional dependency.
  • Participant having angina at rest or in minor effort.
  • Participant having cardiac arrhythmia.
  • Participant having severe airway obstruction I-e GOLD stage 4
  • Participant with hemodynamic instability having heart rate >120 bpm.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    blow bottle positive expiratory pressure

    Water was poured into a 1 L plastic container until it reached a 10 cm height. A 30 cm long tube was put into the water in the bottle, 8 cm deep. The participants were instructed to close their mouths around the tubing in the apparatus for three seconds to produce bubbles, do this for a total of 10 breaths, perform two huffs, then cough. Such exhalations were conducted in two sets of ten, with a five-minute pause in between. For each subject, a fresh, disposable tube and bottle were utilized

    Device: blow bottle positive expiratory pressure

  • Active comparator
    acapella

    Make sure the frequency adjustment dial has been rotated counterclockwise to the lowest frequency-resistance setting before using the Acapella for the first time. On a chair, adopt a straight stance. maintaining a straight back and relaxing your elbows on a table. Now gradually tilt your head upward to maintain the opening of your upper airways. Inhale more deeply than you frequently do. Make sure your lips are encircling the mouthpiece, then blow into the device with a strong expiration. You should ideally blow out roughly twice as quickly as usual. For around ten breaths. Make careful to expel to clear the secretions from the airways after the final try. You can even conduct 2 to 3 "huffs" to improve secretion elimination when necessary. It should be noted that while using the device, you must be capable of exhale for a minimum of three to four seconds.

    Device: acapella

Interventions

  • Deviceblow bottle positive expiratory pressure

    Water was poured into a 1 L plastic container until it reached a 10 cm height. A 30 cm long tube was put into the water in the bottle, 8 cm deep. The participants were instructed to close their mouths around the tubing in the apparatus for three seconds to produce bubbles, do this for a total of 10 breaths, perform two huffs, then cough. Such exhalations were conducted in two sets of ten, with a five-minute pause in between. For each subject, a fresh, disposable tube and bottle were utilized,Because it is a homemade device and can be used with less equipment and with more ease at home . patient perform session three day per week for the duration of 8 weeks , each session last for 35-40 minutes.

  • Deviceacapella

    Make sure the frequency adjustment dial has been rotated counterclockwise to the lowest frequency-resistance setting before using the Acapella for the first time.On a chair, adopt a straight stance. maintaining a straight back and relaxing your elbows on a table. Now gradually tilt your head upward to maintain the opening of your upper airways.Inhale more deeply than you frequently do. Make sure your lips are encircling the mouthpiece, then blow into the device with a strong expiration.You should ideally blow out roughly twice as quickly as usual.For around ten breaths, keep going like this.Make careful to expel to clear the secretions from the airways after the final try. You can even conduct 2 to 3 "huffs" to improve secretion elimination when necessary.It should be noted that while using the device, you must be capable of exhale for a minimum of three to four seconds. patient perform session three day per week for the duration of 8 weeks , each session last for 35-40 minutes

06

What researchers measure

Primary outcomes

  1. pulse oximeter

    Pulse oximeter that measures the proportion of oxygenated hemoglobin in the blood in pulsating vessels, especially the capillaries of the finger or ear.

    Time frame: 8 weeks

  2. peak expiratory flow rate (PEFR)

    Peak expiratory flow rate is the volume of air expelled from the lungs in one quick exhalation and is reliable indicator of ventillation adequacy as well as air flow obstruction .The normal peak flow value can range from person to person and is dependent upon factors such as sex ,age height

    Time frame: 8 weeks

  3. casa q scale

    The cough and sputum assessment questionnaire (CASA-Q) was used to measure the severity and impact of cough and sputum in patients with COPD and chronic bronchitis. CASA-Q scores of each domain demonstrated significant association with HRQoL impairment CASA-Q was strongly lower when chronic bronchitis was present, but multivariate analyses demonstrated that the association of HRQoL impairment was greater with the cough impact domain score than with the usual definition of chronic bronchitis. The CASA-Q targets cough and sputum by an original approach assessing both the symptoms and impacts in dailyactivities within the last 7 days. Each item is answered ranging from never to always or from not at all to a lot / extremely as applicable each type is answered using five categories.

    Time frame: 8 weeks

07

Study locations

1 site
  • Govt .Mian Meer Hospital
    Lahore, Punjab 54000, Pakistan
08

References and documents

Publications

  • Liverani B, Nava S, Polastri M. An integrative review on the positive expiratory pressure (PEP)-bottle therapy for patients with pulmonary diseases. Physiother Res Int. 2020 Jan;25(1):e1823. doi: 10.1002/pri.1823. Epub 2019 Nov 25. PubMed 31762162 ↗
  • Widysanto A, Goldin J, Mathew G. Chronic Bronchitis. 2025 Feb 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482437/ PubMed 29494044 ↗
  • Kim V, Criner GJ. Chronic bronchitis and chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2013 Feb 1;187(3):228-37. doi: 10.1164/rccm.201210-1843CI. Epub 2012 Nov 29. PubMed 23204254 ↗
  • Sehlin M, Ohberg F, Johansson G, Winso O. Physiological responses to positive expiratory pressure breathing: a comparison of the PEP bottle and the PEP mask. Respir Care. 2007 Aug;52(8):1000-5. PubMed 17650355 ↗
  • Patterson JE, Hewitt O, Kent L, Bradbury I, Elborn JS, Bradley JM. Acapella versus 'usual airway clearance' during acute exacerbation in bronchiectasis: a randomized crossover trial. Chron Respir Dis. 2007;4(2):67-74. doi: 10.1177/1479972306075483. PubMed 17621572 ↗
  • Sharma P, Prem V, Jain S. Immediate Effects of Acapella(R) on Dynamic Lung Compliance in Mechanically Ventilated Patients with Acute Respiratory Distress Syndrome: A Case Series. Indian J Crit Care Med. 2018 Feb;22(2):100-102. doi: 10.4103/ijccm.IJCCM_157_17. PubMed 29531450 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2023 to primary completion in Dec 2023, 4 months.

Of 24 interventional studies with no phase under Bronchitis, Chronic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 47. This study's 4 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2023
First posted
Oct 17, 2023
StartActual
Jul 20, 2023
Primary completionActual
Dec 1, 2023
CompletionActual
Dec 10, 2023
Last update
Dec 27, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06086730
Responsible party
Sponsor
First posted
Oct 17, 2023
Start date
Jul 20, 2023
Primary completion
Dec 1, 2023
Completion
Dec 10, 2023
Last update
Dec 27, 2023

Study contacts

Sumera abdulhameed, MS
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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