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Assessment of Emergency Spacers Versus Traditional Spacers for Delivery of Aerosolized Drugs

ConditionsAsthmatic PatientsMDIAerosol Generating Procedure
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-80
SponsorBeni-Suef University

About this trial

* The goal of this clinical trial is to evaluate the performance, feasibility, and safety of emergency spacers compared to traditional spacers for the delivery of aerosolized drugs using pMDI. in young children and adult asthmatic patients The main questions it aims to answer are:

1. Measuring total emitted dose emitted from pMDI alone and attached to spacers. 2. Determining the pharmacokinetic parameter of aerosol delivered by different spacers. 3. Determining the lung bioavailability of aerosol delivered by different spacers. 4. Determining the systemic bioavailability of aerosol delivered by different spacers. 5. Determining the lung function after aerosol delivered by different spacers. 6. Determining the safety Researchers will compare salbutamol amount delivered using pMDI alone and pMDI connected to differents spacers to evaluate the performance, feasibility, and safety of emergency spacers compared to traditional spacers for the delivery of aerosolized drugs.

Participants will asked to * inhale salbutamol through pMDI alone and pMDI connected to different spacers * perform lung function test using spirometer * urine samples will be taken from patients 30 minutes and 24 hours after dose inhalation. * use pulse oximeter to measure heart rate

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Severe asthmatics or patients admitted to an intensive care unit

ischemic heart disease

recent abdominal surgery

inability to perform properly the pulmonary function tests

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ventoline® Evohaler® 100 µg/inhalation pMDI alone

    Drug

    patients use ventoline pMDI alone

  • Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Able spacer

    Drug

    patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Able spacer

  • Ventoline® Evohaler® 100 µg/inhalation pMDI connectec to Tips-Haler spacer

    Drug

    patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connectec to Tips-Haler spacer

  • Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Aerochamber plus flow vu valved holding chamber

    Drug

    patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Aerochamber plus flow vu valved holding chamber

  • Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Atomizer chamber spacer

    Drug

    patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Atomizer chamber spacer

  • Ventoline® Evohaler® 100 µg/inhalation pMDI connected to plastic juice cup spacer

    Drug

    patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to plastic juice cup spacer

  • Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the DispozABLE spacer

    Drug

    patient use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the DispozABLE spacer

  • Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the Lite-Aire collapsible valved holding chamber spacer

    Drug

    patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the Lite-Aire collapsible valved holding chamber spacer

  • Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the MDI package

    Drug

    patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the MDI package

  • Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the hand-made paper sheet spacer

    Drug

    patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the hand-made paper sheet spacer

Treatment groups

120 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: pMDI aloneActive comparator 1 intervention
Group B: Able spacerActive comparator 1 intervention
Group C: Tips-Haler spacerActive comparator 1 intervention
Group D: Aerochaber plus flow vu valved holding chamberActive comparator 1 intervention
Group E: Atomizer chamberActive comparator 1 intervention
Group F: plastic juice cupActive comparator 1 intervention
Group G: DispozABLE SpacerActive comparator 1 intervention
Group H: Lite-Aire Valved holding chamberActive comparator 1 intervention
Group I: ventoline packageActive comparator 1 intervention
Group J: paper sheet spacerActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

the total emitted dose

in-vitro determination of the total emitted dose from pMDI alone and different pMDI-spacer combination using pMDI sampling apparatus (Copley Scientific, Nottingham, United Kingdom)

Time frame
3 months
2

Mass median aerodynamic diameter (MMAD)

in-vitro determination of the aerodynamic particle size of salbutamol after release from the pMDI alone and the pMDI/spacer combinations using Andersen MKII cascade impactor. MMAD will be assessed by CITDAS software (Copley Scientific, Nottingham, UK).

Time frame
3 months
3

fine particle dose (FPD)

in-vitro determination of the aerodynamic particle size of salbutamol after release from the pMDI alone and the pMDI/spacer combinations using Andersen MKII cascade impactor. fine particle dose (FPD) will be assessed by CITDAS software (Copley Scientific, Nottingham, UK).

Time frame
3 months
4

fine particle fraction (FPF)

in-vitro determination of the aerodynamic particle size of salbutamol after release from the pMDI alone and the pMDI/spacer combinations using Andersen MKII cascade impactor. fine particle fraction (FPF) will be assessed by CITDAS software (Copley Scientific, Nottingham, UK).

Time frame
3 months

Secondary outcomes

1

peak expiratory flow (PEF)

(PEF) is tested using One flow spirometer before and 15 minutes after dose inhalation.

Time frame
3months
2

Forced expiratory volume in second (FEV1)

(FEV1) is tested using One flow spirometer before and 15 minutes after dose inhalation.

Time frame
3 months
3

forced vital capacity (FVC)

(FVC) is tested using One flow spirometer before and 15 minutes after dose inhalation.

Time frame
3 months
4

FEV1/FVC ration

FEV1/FVC ration is tested using One flow spirometer before and 15 minutes after dose inhalation.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beni-Suef University

Lead sponsor

Source ClinicalTrials.gov
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