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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 65
Healthy Volunteers: f
View:

• 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).

• 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.

Locations
Other Locations
India
Dr. Jivraj Mehta Smarak Health Foundation
NOT_YET_RECRUITING
Ahmedabad
KLEs Dr Prabhakar Kore Hospital & MRC
NOT_YET_RECRUITING
Belagāve
Medical College and Hospital
NOT_YET_RECRUITING
Kolkata
NRS Medical College and Hospital
NOT_YET_RECRUITING
Kolkata
Aakash Healthcare Super Specialty Hospital
NOT_YET_RECRUITING
New Delhi
Kothrud Hospital
NOT_YET_RECRUITING
Pune
Pimpri Chinchwad Municipal Corporation Post Graduate Institute Yashwantrao Chavan Memorial Hospital
NOT_YET_RECRUITING
Pune
Ashirwad Hospital and Research Centre
NOT_YET_RECRUITING
Ulhasnagar
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Tamshui Mackay Memorial Hospital
RECRUITING
New Taipei City
Shin Kong Wu Ho-Su Memorial Hospital
RECRUITING
Taipei
Taipei Medical University Hospital
RECRUITING
Taipei
Contact Information
Primary
Jasmine Kuo
jasmine.i199@intechbiopharm.com
+886-2-7721-8877
Time Frame
Start Date: 2022-08-15
Estimated Completion Date: 2025-06
Participants
Target number of participants: 148
Treatments
Placebo_comparator: Placebo group
Two different Reference Placebo inhalers and two different Test Placebo inhalers
Active_comparator: Reference 1 group
One Reference inhaler, one Reference Placebo inhaler, and two different Test Placebo inhalers
Active_comparator: Reference 2 group
Two different Reference inhalers and two different Test Placebo inhalers
Experimental: Test group
One Test inhaler, one Test Placebo inhaler, and two different Reference Placebo inhalers
Related Therapeutic Areas
Sponsors
Leads: Intech Biopharm Ltd.

This content was sourced from clinicaltrials.gov

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