Actively Recruiting
Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma
Led by Intech Biopharm Ltd. · Updated on 2025-02-17
148
Participants Needed
12
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or non-pregnant, non-lactating female aged 20 to 65 years inclusive
- Clinical diagnosis of mild asthma per NAEPP 2007 or GINA 2020 guidelines
- Stable mild asthma treated with low-dose inhaled corticosteroids alone or with short-acting beta-agonists for at least 1 month
- Forced Expiratory Volume in 1 second (FEV1) at least 80% of predicted normal after withholding short-acting beta-agonists for 8 hours or more
- Airway responsiveness to methacholine with baseline PC20 8 mg/mL or less
- Non-smoker for at least 6 months with a maximum smoking history of 5 pack-years
- Able to provide written informed consent
- Generally in good health aside from asthma
- Body mass index between 17 and 35 kg/m2 inclusive
- Able to correctly use metered dose inhalers
- Able to perform valid and reproducible pulmonary function tests without spirometry-induced bronchoconstriction
- If of child-bearing potential, using medically acceptable contraception during study
You will not qualify if you...
- Respiratory tract infections or conditions affecting airway reactivity within 6 weeks before screening
- Baseline FEV1 below 60% of predicted normal or less than 1.5 liters
- History of seasonal asthma exacerbations during allergen season
- History of cystic fibrosis, bronchiectasis, COPD, chronic bronchitis, emphysema, tuberculosis, pulmonary carcinoma, pulmonary fibrosis, pulmonary hypertension, or other significant respiratory diseases
- History of cardiovascular, hematological, renal, neurologic, hepatic, psychiatric, or endocrine diseases including ischemic heart disease or significant arrhythmias
- Emergency treatment or hospitalization for asthma within 3 months before screening
- Known allergy or intolerance to albuterol MDI components, beta2 receptor-agonists, HFA, related compounds, or methacholine
- Need for daily oral corticosteroids within 3 months before screening
- Cardiac arrhythmias or ECG abnormalities compromising safety, or QTc above specified limits
- Use of beta blockers or need for them during the study
- History of narrow angle glaucoma, convulsions, hyperthyroidism, uncontrolled diabetes, or paradoxical bronchospasm
- History of malignancies
- History of alcohol or drug abuse
- Eye, brain, thoracic, or abdominal surgery within 3 months before screening
- Use of certain asthma-related medications (cromyolyn, leukotriene receptor antagonists, nedocromil, zileuton, theophylline, long-acting beta-agonists) within 1 month before screening
- Use of muscarinic beta2-agonists, short-acting or long-acting muscarinic antagonists, anti-IgE, anti-IL5/5R, anti-IL4R, high-dose inhaled corticosteroids, or systemic corticosteroids within 6 months before screening
- Known HIV-positive status
- Participation in other interventional clinical trials within 1 month before screening
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Dr. Jivraj Mehta Smarak Health Foundation
Ahmedabad, India, 38007
Not Yet Recruiting
2
KLEs Dr Prabhakar Kore Hospital & MRC
Belagāve, India, 590010
Not Yet Recruiting
3
NRS Medical College and Hospital
Kolkata, India, 700014
Not Yet Recruiting
4
Medical College and Hospital
Kolkata, India, 700073
Not Yet Recruiting
5
Aakash Healthcare Super Specialty Hospital
New Delhi, India, 110075
Not Yet Recruiting
6
Pimpri Chinchwad Municipal Corporation Post Graduate Institute Yashwantrao Chavan Memorial Hospital
Pune, India, 411018
Not Yet Recruiting
7
Kothrud Hospital
Pune, India, 411038
Not Yet Recruiting
8
Ashirwad Hospital and Research Centre
Ulhasnagar, India, 421004
Not Yet Recruiting
9
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Actively Recruiting
10
Tamshui Mackay Memorial Hospital
New Taipei City, Taiwan, 251
Actively Recruiting
11
Taipei Medical University Hospital
Taipei, Taiwan, 110
Actively Recruiting
12
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan, 111
Actively Recruiting
Research Team
J
Jasmine Kuo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
4
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