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

NCT06816342 | Recruiting Phase 4 FDA Drug

• 1 other identifier: FMBSUREC/01102024/ Hashem
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

• 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

Conditions

Asthmatic Patients; MDI; Aerosol Generating Procedure

Keywords

pMDI; valved holding chamber; salbutamol; Aerosol delivery; emergency spacers

Outcome Measures

Primary Outcomes (6)

• 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)

  3 months

• 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).

  3 months

• 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).

  3 months

• 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).

  3 months

• lung bioavailability

  lung bioavailability determined by measuring the concentration of salbutamol in urine 30 minutes after dose administration , Salbutamol levels in urine will be measured using HPLC after samples will be solid-phase extracted

  4 months

• systemic bioavailability

  systemic bioavailability determined by measuring salbutamol concentration 24 hours collectively after dose administration, Salbutamol levels in urine will be measured using HPLC after samples will be solid-phase extracted

  4 months

Secondary Outcomes (5)

• peak expiratory flow (PEF)

  3months

• Forced expiratory volume in second (FEV1)

  3 months

• forced vital capacity (FVC)

  3 months

• FEV1/FVC ration

  3 months

• heart rate

  3 months

Study Arms (10)

pMDI alone

ACTIVE COMPARATOR

patients use pMDI directly without spacer

Drug: Ventoline® Evohaler® 100 µg/inhalation pMDI alone

Able spacer

ACTIVE COMPARATOR

patients use pMDI connected to the Able spacer

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

Tips-Haler spacer

ACTIVE COMPARATOR

patients use pMDI connected to the Tips-Haler spacer

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

Aerochaber plus flow vu valved holding chamber

ACTIVE COMPARATOR

patients use pMDI connected to the Aerochaber plus flow vu valved holding chamber

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

Atomizer chamber

ACTIVE COMPARATOR

patients use pMDI connected to the Atomizer chamber

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

plastic juice cup

ACTIVE COMPARATOR

patients use pMDI connected to a plastic juice cup

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

DispozABLE Spacer

ACTIVE COMPARATOR

patients use pMDI connected to the DispozABLE Spacer

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

Lite-Aire Valved holding chamber

ACTIVE COMPARATOR

patients use pMDI connected to the Lite-Aire Valved holding chamber

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

ventoline package

ACTIVE COMPARATOR

patients use pMDI connected to the ventoline package spacer

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

paper sheet spacer

ACTIVE COMPARATOR

patients use pMDI connected to the paper sheet spacer

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

Interventions

Ventoline® Evohaler® 100 µg/inhalation pMDI alone DRUG

patients use ventoline pMDI alone

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

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

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

Aerochaber 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

Atomizer chamber

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

plastic juice cup

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

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

Lite-Aire Valved holding chamber

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 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

paper sheet spacer

Eligibility Criteria

• Age: 6 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild and moderate asthmatic patients aged from 6 - 80 year old.

You may not qualify if:

• Severe asthmatics or patients admitted to an intensive care unit
• ischemic heart disease
• recent abdominal surgery
• inability to perform properly the pulmonary function tests
• hepatic or renal impairment
• hypersensitivity to salbutamol.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef university hospital

Banī Suwayf, Egypt, Egypt

RECRUITING

Related Publications (1)

• Sayed OA, Laz NI, Abdelrahim ME, Saeed H. Emergency-use spacers: a considerable option for asthmatic patients. Heart Lung. 2026 Jan 2;77:102719. doi: 10.1016/j.hrtlng.2025.102719. Online ahead of print.

  PMID: 41483541 DERIVED

Study Officials

• Mohamed Emam Abdelrahim, professor

  Beni-Suef

  STUDY CHAIR

• Haitham Saeed Abdel-Azeez, Associate professor

  Beni-Suef

  STUDY DIRECTOR

• Nabila Ibrahim Abdel Mageed Laz, professor

  Beni-Suef

  STUDY DIRECTOR

Central Study Contacts

Omar Ahmed Sayed, Demonstrator

CONTACT

+201152677683; OmarAhmed@pharm.bsu.edu.eg

Omar Ahmed Sayed, Demonstrator

CONTACT

+201090313474; omarahmedsayed1111@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator

Model Details: patients were assigned to 10 groups, each group use a specific type of MDI spacers

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: November 1, 2024
• Primary Completion: February 10, 2025
• Study Completion: February 10, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)