Comparison of four inhalation training methods in healthy adult volunteers when they inhale salbutamol through a pressurized inhaler

• Register: ISRCTN
• Last refreshed on: 5 September 2022
• Main ID: ISRCTN88332465
• Date of registration: 06/12/2017
• Prospective Registration: Yes
• Primary sponsor: Al-Ahliyya Amman University
• Public title: Comparison of four inhalation training methods in healthy adult volunteers when they inhale salbutamol through a pressurized inhaler
• Scientific title: Relative lung and systemic bioavailability and oropharyngeal deposition of inhaled salbutamol: evaluation of Trainhaler, Flo-Tone CR, Able Spacer and verbal pMDI counselling
• Date of first enrolment: 15/12/2017
• Target sample size: 16
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN88332465
• Study type: Interventional
• Study design: Investigational four-treatment four-period randomized crossover pharmacokinetic study (Other)
• Phase: Not Applicable

Countries of recruitment

Jordan

Contacts

• Name: Wesam Ammari

Key inclusion & exclusion criteria

Inclusion criteria:
1. Non-smoker
2. Male aged 18 – 50
3. The subject is within the limits for his height & weight as defined by the body mass index range (18.5 – 30.0 kg/m2) or as judged acceptable by the principal investigator/clinical investigator
4. The subject is willing to undergo the necessary pre- & post- medical examinations set by this study
5. The results of medical history, vital signs, physical examination & conducted medical laboratory tests are normal as determined by the clinical investigator
6. The subject tested negative for hepatitis (B & C) viruses and Human Immunodeficiency Virus (HIV)
7. There is no evidence of psychiatric disorder, antagonistic personality, and poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements
8. The subject is able to understand and willing to sign the informed consent form
9. The subject has normal cardiovascular system and ECG recording

Exclusion criteria:
1. The subject has suffered an acute illness one week before dosing
2. The subject has a history of or concurrent abuse of alcohol
3. The subject has a history of or concurrent abuse of illicit drugs
4. The subject has a history of hypersensitivity and/or contraindications to the study drug and any related compounds.
5. The subject has been hospitalized within three months before the study or during the study
6. The subject is vegetarian
7. The subject has consumed caffeine or xanthine containing beverages or foodstuffs within two days before dosing and until 24 hours after dosing in either study period
8. The subject has taken a prescription medication within two weeks or even an over the counter product (OTC) within one week before dosing in each study period and any time during the study
9. The subject has taken grapefruit containing beverages or foodstuffs within seven (7) days before first dosing and any time during the study
10. The subject has been participating in any clinical study (e.g. pharmacokinetics, bioavailability and bioequivalence studies) within the last 80 days prior to the present study
11. The subject has a history or presence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinal, immunological, dermatological, neurological, musculoskeletal or psychiatric diseases


Age minimum:
Age maximum:
Gender: Male

Health Condition(s) or Problem(s) studied

Testing ways of improving inhaler technique in healthy volunteers
Respiratory

Intervention(s)

The study will evaluate and compare the impact of using the Trainhaler (TH), Flo-Tone CR (FT), Able Spacer (AS) and Verbal pMDI technique counselling (VC) methods on the relative lung and systemic bioavailability of salbutamol inhaled by healthy adult volunteers. Additionally, oropharyngeal deposition will be assessed immediately post inhalation.

The Trainhaler (TH), Flo-Tone CR (FT), Able Spacer (AS) are manufactured by Clement Clarke International, UK.
Ventolin® Evohaler® (100 µg/puff), GlaxoSmithKline, will be used as the salbutamol pMDI. The 30-min urinary excretion pharmacokinetic method will be used to determine the relative lung and systemic bioavailability following salbutamol inhalation. The salbutamol oropharyngeal deposition will be assessed by analysing mouthwash aqueous samples collected immediately post-inhalation.

Enrolled healthy volunteers will be randomized into a four-period, four-treatment (TH, FT, AS and VC) based on a randomization table constructed prior to study recruitment.

Primary Outcome(s)

1. Relative lung bioavailability of inhaled salbutamol, assessed by determining salbutamol concentration using a developed and validated HPLC-MS/MS analytical method in urine sample given 30 minutes post inhalation from Ventolin Evohaler using the assigned inhalation technique method
2. Relative systemic bioavailability of inhaled salbutamol, assessed by determining salbutamol concentration using a developed and validated HPLC-MS/MS analytical method in urine samples given at 60, 120 minutes and in urine subsequently pooled for 24 hours post inhalation from Ventolin Evohaler using the assigned inhalation technique method

Secondary Outcome(s)

Salbutamol oropharyngeal deposition, assessed using a developed and validated HPLC-MS/MS analytical method in mouthwash aqueous samples collected immediately post-inhalation

Secondary ID(s)

Protocol Code: 694-2017, V.03 / Project Code: BC-SAL-16/547

Source(s) of Monetary Support

Al-Ahliyya Amman University, Clement Clarke International Ltd

Ethics review

Status:
Approval date:
Contact:

1. ACDIMA BioCenter Institutional Review Board (IRB), 12/03/2017 2. Jordan Food and Drug Administration (JFDA) Clinical Studies Committee, 25/07/2017, ref: 01/30/2017

Results

• Results available: Yes
• Date Completed: 30/06/2018