NCT02624505

Brief Summary

The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

10 months

First QC Date

December 4, 2015

Last Update Submit

July 23, 2019

Conditions

Bronchial Asthma

Outcome Measures

Primary Outcomes (1)

  • Provocative Concentration of Methacholine Causing 20 % Fall (PC20) in FEV1(Forced Expiratory Volume in 1 second)

    1 day

Study Arms (4)

Placebo Product

PLACEBO COMPARATOR

One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols

Drug: Placebo

90 mcg Reference Product

ACTIVE COMPARATOR

Drug : 90 mcg Reference Product One actuation each from the Reference inhalation aerosol and the placebo Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols

Drug: 90 mcg Reference Product

180 mcg Reference Product

ACTIVE COMPARATOR

Drug: 180 mcg Reference Product One actuation each from two different Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols

Drug: 180 mcg Reference Product

90 mcg Test Product

EXPERIMENTAL

Drug: 90 mcg Test Product One actuation each from the Test inhalation aerosol and the placebo Test inhalation aerosol and one actuation each from two different placebo Reference inhalation aerosols

Drug: 90 mcg Test Product

Interventions

90 mcg Reference ProductDRUG

Drug: 90 mcg Reference Product

Also known as: Albuterol
90 mcg Reference Product
180 mcg Reference ProductDRUG

Drug: 180 mcg of Reference Product

Also known as: Albuetrol
180 mcg Reference Product
90 mcg Test ProductDRUG

Drug: 90 mcg of Test Product

Also known as: Albuterol
90 mcg Test Product
PlaceboDRUG

Placebo Product

Placebo Product

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and non-pregnant female subjects (18-65 years of age)
  • Forced Expiratory Volume in 1 second (FEV1) ≥ 80% of predicted. Airway responsiveness to methacholine demonstrated by a pre-albuterol dose (baseline) PC20 ≤ 8 mg/ml.
  • Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines.
  • Nonsmokers for at least 6 months prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years).
  • Written informed consent.

You may not qualify if:

  • Conditions which could alter airway reactivity to methacholine (e.g., pneumonia, upper respiratory tract infection, viral bronchitis and/or sinobronchitis) within six weeks prior to the screening visit.
  • History of seasonal asthma exacerbations, in which case the patient should be studied outside of the relevant allergen season.
  • History of a clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia.
  • History of cystic fibrosis, bronchiectasis or other respiratory diseases other than Asthma
  • Historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases
  • Known intolerance or hypersensitivity or hypersensitivity to any component of the albuterol metered dose inhaler (MDI).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorado Allergy and Asthma Centers

Denver, Colorado, 80230, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Officials

  • Dhiraj Abhyankar

    Cipla Ltd.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2015

First Posted

December 8, 2015

Study Start

December 1, 2015

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

July 25, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Undecided

Locations

US(1)