Mild AsthmaNCT04912596
Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma
A study testing Albuterol Sulfate inhalation aerosol 108 mcg per actuation, Proair HFA (Albuterol Sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg per actuation and Methacholine in people with Mild Asthma, run by Intech Biopharm Ltd. at 12 sites in 2 countries.
Trial summary
The objective of this study is to evaluate the pharmacodynamic (PD) bioequivalence (BE) of albuterol inhalers, test formulation: Albuterol Sulfate HFA inhalation aerosol 108 mcg (equal to albuterol base 90 mcg) per actuation and reference formulation: ProAir HFA (albuterol sulfate) or FDA authorized generic: Albuterol… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Mild Asthma
- What is being tested?
- Albuterol Sulfate inhalation aerosol 108 mcg per actuation, Proair HFA (Albuterol Sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg per actuation and Methacholine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 15 Aug 2022to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, non-pregnant and non-lactating female subjects (20-65 years of age, inclusive).
- A clinical diagnosis of mild asthma with historical documentation of the asthma diagnosis according to either: (1) the National Asthma Education and Prevention Program (NAEPP) guidelines (2007) or (2) the Global Initiative for Asthma (GINA) Global Strategy for Asthma Management and Prevention (2020).
- Stable mild asthma receiving the following required inhaled medications for at least 1 month prior to screening: Low doses of ICS alone, or in combination with SABA, used regularly with a stable regimen.
- Forced Expiratory Volume in 1 second (FEV1) ≥ 80% of the local predicted normal value after withholding SABA ≥ 8 hours.
- Airway responsiveness to methacholine demonstrated by a pre-albuterol-dose (baseline) PC20 ≤ 8 mg/mL.
- Nonsmoker for at least 6 months prior to the study and a maximum smoking history of 5 pack-years (the equivalent of one pack per day for 5 years).
Show all 12Show fewer
- Provision of written informed consent.
- Other than asthma, in general good health.
- Body mass index (BMI) between 17 and 35 kg/m2 (inclusive).
- Able to correctly use MDI inhalers.
- Able to perform valid and reproducible pulmonary function tests including no evidence of spirometry effort-induced bronchoconstriction.
- If the subject or subject's partner is of child-bearing potential, a medically acceptable form of contraception will be used for the duration of the study. Medically acceptable contraceptives include: (1) surgical sterilization, (2) Health Authority approved female hormonal contraceptives, (3) an intrauterine device (IUD), (4) condoms with spermicide, or (5) diaphragm with spermicide.
Who cannot join
- Evidence of conditions altering airway reactivity to methacholine, including upper or lower respiratory tract infections (e.g., pneumonia, viral bronchitis, allergic rhinitis, sinobronchitis, etc.) within 6 weeks before Screening.
- Evidence of a baseline FEV1 < 60% of the local predicted normal value or FEV1 < 1.5 L.
- History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season.
- History of cystic fibrosis, bronchiectasis, COPD, or other respiratory diseases including COPD, chronic bronchitis, emphysema, tuberculosis, pulmonary carcinoma, pulmonary fibrosis, pulmonary hypertension that, in the opinion of the Investigator, would compromise subject safety or interfere with the evaluations.
- History of cardiovascular, hematological, renal, neurologic, hepatic, psychiatric, endocrine dysfunction, including ECG with evidence of ischemic heart diseases and significant arrhythmias.
- Treatment in an emergency room or hospitalization for acute asthmatic symptoms within 3 months prior to screening.
Show all 19Show fewer
- Known intolerance or hypersensitivity to any component of the albuterol MDI, beta2 receptor-agonist drug, HFA, any related compounds or methacholine.
- Need for daily oral corticosteroids within 3 months prior to screening.
- Cardiac arrhythmia or 12-lead electrocardiogram (ECG) abnormalities, that in the opinion of the Investigator would compromise subject safety or interfere with the evaluations, or a QTc > 440 ms for males and > 460 ms for females using Fredericia formula.
- Subjects receiving beta blocker via any route or who may require beta blockers during the study.
- History of narrow angle glaucoma, convulsive disorders, hyperthyroidism, uncontrolled diabetes, paradoxical bronchospasm.
- History of malignancies.
- History of alcohol or drug abuse.
- Eye, brain, thoracic, and abdominal surgeries within 3 months prior to screening.
- Use of cromyolyn, leukotriene receptor antagonists (LTRA), nedocromil, zileuton, theophylline, or long-acting beta-agonists (LABA) within 1 month prior to screening.
- History of receiving muscarinic beta2-agonists (MABAs), short-acting muscarinic antagonists (SAMAs), long-acting muscarinic antagonists (LAMAs), anti-IgE, anti-IL5/5R, anti-IL4R, high dose ICS, or systemic corticosteroid for treatment of asthma within 6 months prior to screening.
- Known Human Immunodeficiency Virus (HIV)-positive status.
- Participated in any interventional clinical trials within 1 month prior to screening.
- Pregnancy or breast feeding.
Trial locations and contacts
12 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 2 countries
India8 sites, 8 recruiting
- Not yet recruiting
Dr. Jivraj Mehta Smarak Health Foundation
Ahmedabad, 38007
Vaishal Sheth
Vaishal Sheth
- Not yet recruiting
KLEs Dr Prabhakar Kore Hospital & MRC
Belagāve, 590010
Jyothi Hattiholi
Jyothi Hattiholi
- Not yet recruiting
NRS Medical College and Hospital
Kolkata, 700014
Jaydip Deb
Jaydip Deb
- Not yet recruiting
Medical College and Hospital
Kolkata, 700073
Kaushik Saha
Kaushik Saha
- Not yet recruiting
Aakash Healthcare Super Specialty Hospital
New Delhi, 110075
Akshay Budhraja
Akshay Budhraja
- Not yet recruiting
Pimpri Chinchwad Municipal Corporation Post Graduate Institute Yashwantrao Chavan Memorial Hospital
Pune, 411018
Pravin Soni
Pravin Soni
- Not yet recruiting
Kothrud Hospital
Pune, 411038
Himanshu Pophale
Himanshu Pophale
- Not yet recruiting
Ashirwad Hospital and Research Centre
Ulhasnagar, 421004
Shrikant Vishnu Deshpande
Shrikant Vishnu Deshpande
Taiwan4 sites, 4 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Chau-Chyun Sheu, MD
Chau-Chyun Sheu, MD
- Recruiting
Tamshui Mackay Memorial Hospital
New Taipei City, 251
Hsin-Pei Chung, MD
Hsin-Pei Chung, MD
- Recruiting
Taipei Medical University Hospital
Taipei, 110
Pai-Chien Chou, MD, PhD
Pai-Chien Chou, MD, PhD
- Recruiting
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111
Shih-Sen Lin, MD
Shih-Sen Lin, MD
About this study
Official title: A Randomized, Single-dose, Double-blind, Double-dummy, Placebo and Active Controlled, Crossover Design Study Using Bronchoprovocation to Evaluate the Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma
The objective of this study is to evaluate the pharmacodynamic (PD) bioequivalence (BE) of albuterol inhalers, test formulation: Albuterol Sulfate HFA inhalation aerosol 108 mcg (equal to albuterol base 90 mcg) per actuation and reference formulation: ProAir HFA (albuterol sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg (equal to albuterol base 90 mcg) per actuation manufactured by two different manufacturers using methacholine bronchoprovocation challenge test in patients with stable mild asthma.
Read the detailed description
This study will be conducted using the single-dose, randomized, double-blind, double-dummy, four-sequence, four-treatment, and multiple-center study design to evaluate the PD bioequivalence between the test albuterol sulfate (T) inhalation aerosol 108 mcg per actuation (eq. to albuterol base 90 mcg/puff) and the reference albuterol sulfate (R) (ProAir HFA or FDA authorized generic: Albuterol Sulfate HFA [Teva Pharmaceutical USA, Inc.]) inhalation aerosol 108 mcg per actuation (equal to albuterol base 90 mcg/puff). The two products will be studied using a crossover design in patients with stable mild asthma by administering a minimum of 3 doses of reference product (0, 90, 180 mcg albuterol) and 2 doses of test product (0, 90 mcg albuterol). The bronchodilation potency of albuterol sulfate are measured by the inhibition effects of methacholine challenge on the bronchodilation, as indicated by increase in the provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20).
- Conditions
- Mild Asthma
- Being tested
- Albuterol Sulfate inhalation aerosol 108 mcg per actuation, Proair HFA (Albuterol Sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg per actuation, Proair HFA or FDA authorized generic: Albuterol Sulfate HFA Inhalation Placebo, Albuterol Sulfate inhalation Placebo, Methacholine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albuterol Sulfate inhalation aerosol 108 mcg per actuationDrug
Also called Albuterol Sulfate
equal to albuterol 90 mcg/puff, MDI
Proair HFA (Albuterol Sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg per actuationDrug
Also called Albuterol Sulfate
equal to albuterol 90 mcg/puff, MDI
Proair HFA or FDA authorized generic: Albuterol Sulfate HFA Inhalation PlaceboOther
MDI
Albuterol Sulfate inhalation PlaceboOther
MDI
MethacholineOther
Methacholine 100 mg/vial
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Two different Reference Placebo inhalers and two different Test Placebo inhalers Receives: Other: Proair HFA or FDA authorized generic: Albuterol Sulfate HFA Inhalation Placebo; Other: Albuterol Sulfate inhalation Placebo; Other: Methacholine |
| Reference 1 group | Active comparator | One Reference inhaler, one Reference Placebo inhaler, and two different Test Placebo inhalers Receives: Drug: Proair HFA (Albuterol Sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg per actuation; Other: Proair HFA or FDA authorized generic: Albuterol Sulfate HFA Inhalation Placebo; Other: Albuterol Sulfate inhalation Placebo; Other: Methacholine |
| Reference 2 group | Active comparator | Two different Reference inhalers and two different Test Placebo inhalers Receives: Drug: Proair HFA (Albuterol Sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg per actuation; Other: Albuterol Sulfate inhalation Placebo; Other: Methacholine |
| Test group | Experimental | One Test inhaler, one Test Placebo inhaler, and two different Reference Placebo inhalers Receives: Drug: Albuterol Sulfate inhalation aerosol 108 mcg per actuation; Other: Proair HFA or FDA authorized generic: Albuterol Sulfate HFA Inhalation Placebo; Other: Albuterol Sulfate inhalation Placebo; Other: Methacholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-dose PC20 Concentration
Post-dose PC20, which are the provocative concentrations, respectively, of the methacholine challenge agent required to reduce the forced expiratory volume in one second (FEV1) by 20% following administration of differing concentrations of albuterol (or placebo) by inhalation.
Measured: 15 minutes post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start15 Aug 2022
- Primary completion31 Jan 2025
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intech Biopharm Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pai-Chien Chou, MD, PhD, Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912596
- Sponsor's protocol ID
- TW20-4643
- Status last verified
- Feb 2025
- First submitted
- 28 May 2021
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-dose, Double-blind, Double-dummy, Placebo and Active Controlled, Crossover Design Study Using Bronchoprovocation to Evaluate the Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma
- ClinicalTrials.gov ID
- NCT04912596
- Acronym / sponsor ID
- TW20-4643
- Conditions
- Mild Asthma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Intech Biopharm Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- Jun 2025 (estimated)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the pharmacodynamic (PD) bioequivalence (BE) of albuterol inhalers, test formulation: Albuterol Sulfate HFA inhalation aerosol 108 mcg (equal to albuterol base 90 mcg) per actuation and reference formulation: ProAir HFA (albuterol sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg (equal to albuterol base 90 mcg) per actuation manufactured by two different manufacturers using methacholine bronchoprovocation challenge test in patients with stable mild asthma.
Detailed description
This study will be conducted using the single-dose, randomized, double-blind, double-dummy, four-sequence, four-treatment, and multiple-center study design to evaluate the PD bioequivalence between the test albuterol sulfate (T) inhalation aerosol 108 mcg per actuation (eq. to albuterol base 90 mcg/puff) and the reference albuterol sulfate (R) (ProAir HFA or FDA authorized generic: Albuterol Sulfate HFA [Teva Pharmaceutical USA, Inc.]) inhalation aerosol 108 mcg per actuation (equal to albuterol base 90 mcg/puff). The two products will be studied using a crossover design in patients with stable mild asthma by administering a minimum of 3 doses of reference product (0, 90, 180 mcg albuterol) and 2 doses of test product (0, 90 mcg albuterol). The bronchodilation potency of albuterol sulfate are measured by the inhibition effects of methacholine challenge on the bronchodilation, as indicated by increase in the provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: Proair HFA or FDA authorized generic: Albuterol Sulfate HFA Inhalation Placebo, Other: Albuterol Sulfate inhalation Placebo, Other: MethacholineTwo different Reference Placebo inhalers and two different Test Placebo inhalers |
| Reference 1 group | Active comparator | Drug: Proair HFA (Albuterol Sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg per actuation, Other: Proair HFA or FDA authorized generic: Albuterol Sulfate HFA Inhalation Placebo, Other: Albuterol Sulfate inhalation Placebo, Other: MethacholineOne Reference inhaler, one Reference Placebo inhaler, and two different Test Placebo inhalers |
| Reference 2 group | Active comparator | Drug: Proair HFA (Albuterol Sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg per actuation, Other: Albuterol Sulfate inhalation Placebo, Other: MethacholineTwo different Reference inhalers and two different Test Placebo inhalers |
| Test group | Experimental | Drug: Albuterol Sulfate inhalation aerosol 108 mcg per actuation, Other: Proair HFA or FDA authorized generic: Albuterol Sulfate HFA Inhalation Placebo, Other: Albuterol Sulfate inhalation Placebo, Other: MethacholineOne Test inhaler, one Test Placebo inhaler, and two different Reference Placebo inhalers |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male, non-pregnant and non-lactating female subjects (20-65 years of age, inclusive).
- A clinical diagnosis of mild asthma with historical documentation of the asthma diagnosis according to either: (1) the National Asthma Education and Prevention Program (NAEPP) guidelines (2007) or (2) the Global Initiative for Asthma (GINA) Global Strategy for Asthma Management and Prevention (2020).
- Stable mild asthma receiving the following required inhaled medications for at least 1 month prior to screening: Low doses of ICS alone, or in combination with SABA, used regularly with a stable regimen.
- Forced Expiratory Volume in 1 second (FEV1) ≥ 80% of the local predicted normal value after withholding SABA ≥ 8 hours.
- Airway responsiveness to methacholine demonstrated by a pre-albuterol-dose (baseline) PC20 ≤ 8 mg/mL.
Key exclusion criteria (19 listed)
- Evidence of conditions altering airway reactivity to methacholine, including upper or lower respiratory tract infections (e.g., pneumonia, viral bronchitis, allergic rhinitis, sinobronchitis, etc.) within 6 weeks before Screening.
- Evidence of a baseline FEV1 < 60% of the local predicted normal value or FEV1 < 1.5 L.
- History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season.
- History of cystic fibrosis, bronchiectasis, COPD, or other respiratory diseases including COPD, chronic bronchitis, emphysema, tuberculosis, pulmonary carcinoma, pulmonary fibrosis, pulmonary hypertension that, in the opinion of the Investigator, would compromise subject safety or interfere with the evaluations.
- History of cardiovascular, hematological, renal, neurologic, hepatic, psychiatric, endocrine dysfunction, including ECG with evidence of ischemic heart diseases and significant arrhythmias.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albuterol Sulfate inhalation aerosol 108 mcg per actuationAlso: Albuterol Sulfateequal to albuterol 90 mcg/puff, MDI | Drug | Test group |
| Proair HFA (Albuterol Sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg per actuationAlso: Albuterol Sulfateequal to albuterol 90 mcg/puff, MDI | Drug | Reference 1 group, Reference 2 group |
| Proair HFA or FDA authorized generic: Albuterol Sulfate HFA Inhalation PlaceboMDI | Other | Placebo group, Reference 1 group, Test group |
| Albuterol Sulfate inhalation PlaceboMDI | Other | Placebo group, Reference 1 group, Reference 2 group, Test group |
| MethacholineMethacholine 100 mg/vial | Other | Placebo group, Reference 1 group, Reference 2 group, Test group |
Primary outcome
Post-dose PC20 Concentration
Time frame: 15 minutes post-dose
Post-dose PC20, which are the provocative concentrations, respectively, of the methacholine challenge agent required to reduce the forced expiratory volume in one second (FEV1) by 20% following administration of differing concentrations of albuterol (or placebo) by inhalation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pai-Chien Chou, MD, PhD principal investigator
Taipei Medical University Hospital
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albuterol Sulfate inhalation aerosol 108 mcg per actuation, Proair HFA (Albuterol Sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg per actuation and Methacholine in people with Mild Asthma, run by Intech Biopharm Ltd. at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in India, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jasmine Kuo (+886-2-7721-8877 ext. 688, jasmine.i199@intechbiopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-dose PC20 Concentration (time frame: 15 minutes post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.