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Taking peoplePhase 1

Compares two salbutamol inhaler propellants in adults with mild asthma

Tests whether a newer propellant works like the standard one in salbutamol inhalers.

Key facts

Who runs it
GlaxoSmithKline
Where
Sofia, BulgariaSee the siteAlso in 4 other countries, 5 sites
Registry title
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Status
Recruiting
Phase
Phase 1
People taking part
84 people, planned
Started
14 Aug 2024
Expected to end
16 Apr 2027
Type of study
Interventional, 2 groups
Treatments tested
  • Salbutamol HFA-152a
  • Salbutamol HFA-134a
  • Placebo
Record updated
6 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 65 with mild asthma who take stable asthma treatment. It compares two versions of a salbutamol inhaler.

Age
18 to 65 years
Sex
Men and women can join.
Disease stage
Mild asthma, documented for at least 6 months. Lung function (FEV1) of at least 80% of predicted. Methacholine PC20 of 8 mg/mL or less.
Earlier treatment
Stable asthma treatment for at least 12 weeks: SABA only, or low-dose inhaled steroid (100-250 μg/day fluticasone propionate or equivalent), with or without a LABA. Must be able to pause SABA for 12 hours and LABA for 48 hours before tests.
Biomarker or test result
Methacholine PC20 of 8 mg/mL or less at screening.

Main reasons for not taking part

  • History of life-threatening or unstable asthma
  • Other lung diseases, such as COPD, cystic fibrosis or tuberculosis
  • Tobacco or nicotine use in the last 12 months, or more than 10 pack years
  • Pregnant or breastfeeding women
  • Regular heavy alcohol use or a positive drug test

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal
  • Participant must be 18 to 65 years of age inclusive, at the time of screening
  • ≥50 kg, at the time of screening
  • Body mass index (BMI) with 19.0-35.0 kg/m2 inclusive, at the time of screening
  • Documented history of asthma ≥ 6 months. 5. Receiving 1 of following asthma treatments, at a stable dose, for at least 12 weeks prior to the screening visit and is anticipated to remain stable for the duration of the study: i. Short-acting beta-agonist (SABA) only. ii. Daily maintenance low-dose inhaled corticosteroids (ICS) (defined as 100-250 μg/day fluticasone propionate or equivalent plus or minus SABA which is anticipated to remain stable for the duration of the study
  • Daily maintenance low-dose ICS + Long-acting beta-2 agonist (LABA) therapy (low-dose ICS defined as 100-250 μg/day fluticasone propionate or equivalent as defined by GINA [GINA, 2023]) plus or minus SABA, which is anticipated to remain stable for the duration of the study
  • No severe asthma exacerbations within 6 months prior to screening and ≤1 severe exacerbation during the 12 months prior to screening
  • Pre-bronchodilator FEV1 ≥80% of predicted, at screening. 8. PC20 to methacholine of ≤8 mg/mL, at screening. 9. Participants should be able to withhold SABA for ≥12 hours and LABA-containing medications for ≥48 hours for the purposes of performing the spirometry and methacholine challenge at screening and during the study visits (treatment periods)
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and Is a woman of woman of nonchildbearing potential (WONCBP) OR ii. Is a woman of child bearing potential (WOCBP) and using a contraceptive method that is highly effective
  • Provide signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol
  • Non-smokers who have not used any tobacco containing-products within 12 months prior to study start, and with a total pack year history of ≤10 pack years

Who cannot take part

  • Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day or participation in a clinical study within 30 days of study start, or 5 half-lives of study drug if that is longer
  • Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of >21 units for males or >14 units for females
  • A positive test result for drugs of abuse (including tetrahydrocannabinol) at screening or Day -1
  • Use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to "vape" within 12 months prior to the start of the study
  • Medical Conditions; A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator; A history of respiratory diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, cystic fibrosis, bronchiectasis, interstitial lung disease, emphysema, chronic obstructive pulmonary disease, tuberculosis, or other respiratory abnormalities other than asthma; Asymptomatic gallstones; History or current evidence of hematologic, neurologic, psychiatric, or other diseases that, in the opinion of the investigator, would put the participant at risk through study participation, or would affect the study analyses if the disease exacerbates during the study; Recent eye surgery or any other condition in which raised intracranial pressure (caused by forceful exhalation) would be harmful; Current use of cholinesterase inhibitor medication e.g., to treat myasthenia gravis
  • Participants who are currently or in the last 15 days have worked nightshifts

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in Bulgaria

Also in 4 other countries, 5 sites

  • Medical Center Comac Medical Ltd.Sofia, BulgariaNo longer taking part

About the trial

What the trial wants to find out

The primary objectives of the study are: Part 1: to characterize the potency and variability of dose response on efficacy (Provocative concentration of methacholine causing at least a 20% fall in forced expiratory volume (FEV1) [PC20]) of salbutamol administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma. Part 2: to compare the comparative dose response on efficacy (PC20) of salbutamol when administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma.

The 2 groups in the trial

  • Part 1Treatment being tested

    Part 1 will consist of a 7 treatment, 7 period cross-over evaluation with all participants receiving the following treatments once, randomized to varying pre-specified sequences of: * Zero dose (placebo of both salbutamol HFA-134a and salbutamol HFA-152a) * 100 μg salbutamol HFA-134a * 200 μg salbutamol HFA-134a * 400 μg salbutamol HFA-134a * 100 μg salbutamol HFA-152a * 200 μg salbutamol HFA-152a * 400 μg salbutamol HFA-152a A minimum of a 2-day and maximum of a 7-day methacholine washout will separate each treatment period.

    Treatment: Salbutamol HFA-152a, Salbutamol HFA-134a, and Placebo

  • Part 2Treatment being tested

    Part 2 will consist of a 7 treatment, 7-way cross-over with all participants receiving the following treatments given once, randomized to varying pre-specified sequences of: * Zero dose (placebo of both salbutamol HFA-134a and salbutamol HFA-152a) * 100 μg salbutamol HFA-134a * 200 μg salbutamol HFA-134a * 400 μg salbutamol HFA-134a * 100 μg salbutamol HFA-152a * 200 μg salbutamol HFA-152a * 400 μg salbutamol HFA-152a A minimum of a 3-day and maximum of a 7-day methacholine washout will separate each treatment period.

    Treatment: Salbutamol HFA-152a, Salbutamol HFA-134a, and Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 1, Randomized, 2-part, 7-way Cross-over (Part 1) and 7-way Cross-over (Part 2), Blinded, Single Dose Study in Mild Asthmatics Aged 18-65 to Assess the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152a (Test) and HFA-134a (Reference) Via Methacholine Bronchoprovocation and Systemic Pharmacodynamic Effects
Plain-language title
Compares two salbutamol inhaler propellants in adults with mild asthmaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06433921, who can take part
Record updated
6 November 2026