← Back to Search

Bronchodilator

Albuterol Inhaler for Asthma

Phase 3

Waitlist Available

Led By Sarah Smiley

Research Sponsored by Cipla Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject must demonstrate airway responsiveness to methacholine at baseline (pre-albuterol dose) PC20 at ≤8 mg/mL concentration of methacholine (Equivalent to PD20 of ≤513 µg) at the first screening MBPC

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

Study Summary

This trial tests if a medicine works the same in people with mild asthma, using breathing tests.

Who is the study for?

This trial is for adults with stable mild asthma diagnosed at least 6 months ago. Participants must have normal or near-normal lung function and show a specific reaction to an asthma trigger during testing. They should also have a body mass index (BMI) between 18 and 35.Check my eligibility

What is being tested?

The study aims to compare the effectiveness of Albuterol Sulfate Inhalation Aerosol with Ventolin HFA, another inhaler, and a placebo in improving breathing in patients with mild asthma using methacholine challenge tests.See study design

What are the potential side effects?

Albuterol may cause side effects like shaking, headache, throat irritation, changes in taste, fast heart rate, dizziness, coughing or nervousness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My asthma reacts strongly to a specific test before taking my usual medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Provocative Dose of Methacholine Causing 20 % Fall (PD20) in FEV1(Forced Expiratory Volume in 1 second)

Side effects data

From 2014 Phase 4 trial • 152 Patients • NCT01922271

Nasopharyngitis

Hypercholesterolaemia

Acute myocardial infarction

Myocardial infarction

Condition aggravated

Urinary tract infection

Excoriation

Headache

Chronic obstructive pulmonary disease

Cough

Dyspnoea

100%

80%

60%

40%

20%

Study treatment Arm

NVA237

Tiotropium

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Test ProductExperimental Treatment1 Intervention

One actuation from the test inhalation aerosol and one actuation each from three different placebo inhalation aerosols

Group II: Reference 180mcg ProductActive Control1 Intervention

One actuation each from two different reference inhalation aerosols and one actuation each from two different placebo inhalation aerosols

Group III: Reference 90mcg ProductActive Control1 Intervention

One actuation from the reference inhalation aerosol and one actuation each from three different placebo inhalation aerosols.

Group IV: Placebo ProductPlacebo Group1 Intervention

One actuation each from four different placebo inhalation aerosols.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cipla Ltd.Lead Sponsor

7 Previous Clinical Trials

28,389 Total Patients Enrolled

3 Trials studying Asthma

2,961 Patients Enrolled for Asthma

Sarah SmileyPrincipal InvestigatorVelocity Clinical Research

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation include older adults?

"According to the inclusion criteria, participants must be aged 18-65. Additionally, further research is being conducted on those younger and older than that age bracket - 128 clinical studies for under 18s and 200 trials focusing on senior citizens."

Answered by AI

Is it still possible to participate in this investigation?

"Clinicaltrials.gov indicates that this study is not presently seeking participants, although it was posted on December 11th 2023 and updated most recently on November 23rd 2023. Nevertheless, there are 311 other clinical studies currently open to volunteers."

Answered by AI

Which individuals can participate in this medical research experiment?

"Eligibility criteria for this medical trial include asthma diagnosis and a patient age range between 18 and 65. The total number of participants the study is looking to recruit is 120."

Answered by AI

What possible risks might patients incur from using Test Product?

"Data has been gathered that supports the efficacy of Test Product, prompting our team to give it a safety score of 3. Multiple rounds of data support this evaluation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation in Patients With Stable Mild Asthma

2023. "BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation in Patients With Stable Mild Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06154304.