Your session is about to expire
← Back to Search
Bronchodilator
Salbutamol Methods for Asthma
Phase 4
Waitlist Available
Led By Don Cockcroft, MD
Research Sponsored by University of Saskatchewan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-60 minutes
Awards & highlights
Study Summary
This trial will compare different ways of using salbutamol to treat airway narrowing caused by methacholine.
Who is the study for?
This trial is for adults with asthma who have a stable lung function (FEV1 ≥ 65% predicted) and react to methacholine, a substance used in breathing tests. Participants should not be pregnant, breastfeeding, smokers, or have had respiratory infections or exposure to asthma triggers within the last month.Check my eligibility
What is being tested?
The study aims to compare how effective two forms of salbutamol are at reversing constriction caused by methacholine: one delivered through an inhaler with a spacer and the other via a nebulizer. A placebo group is also included for comparison.See study design
What are the potential side effects?
Salbutamol may cause side effects like tremors, headache, fast heart rate, and muscle cramps. The severity can vary from person to person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-60 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-60 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Lung function recovery
Secondary outcome measures
Heart rate
Time to lung function recovery
Side effects data
From 2014 Phase 4 trial • 152 Patients • NCT019222712%
Nasopharyngitis
1%
Hypercholesterolaemia
1%
Acute myocardial infarction
1%
Myocardial infarction
1%
Condition aggravated
1%
Urinary tract infection
1%
Excoriation
1%
Headache
1%
Chronic obstructive pulmonary disease
1%
Cough
1%
Dyspnoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
NVA237
Tiotropium
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: salbutamol delivered with vibrating mesh nebulizerExperimental Treatment1 Intervention
200microliters of salbutamol will be administered using a vibrating mesh nebulizer
Group II: salbutamol delivered via pressurized metered dose inhalerActive Control1 Intervention
200mcg of salbutamol will be delivered using a pressurized metered dose inhaler plus spacer
Group III: placeboPlacebo Group1 Intervention
normal saline will be administered with a vibrating mesh nebulizer and 200mcg of placebo will be administered using a pressurized metered dose inhaler plus spacer
Find a Location
Who is running the clinical trial?
University of SaskatchewanLead Sponsor
251 Previous Clinical Trials
154,390 Total Patients Enrolled
23 Trials studying Asthma
460 Patients Enrolled for Asthma
Don Cockcroft, MDPrincipal InvestigatorUniversity of Saskatchewan
9 Previous Clinical Trials
207 Total Patients Enrolled
8 Trials studying Asthma
173 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a respiratory infection in the last 4 weeks.I was exposed to something that worsened my breathing recently.I am 18 years old or older.I have no major health issues other than asthma.
Research Study Groups:
This trial has the following groups:- Group 1: salbutamol delivered via pressurized metered dose inhaler
- Group 2: placebo
- Group 3: salbutamol delivered with vibrating mesh nebulizer
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent does inhaling salbutamol through a vibrating mesh nebulizer pose risks for those using the device?
"The safety of salbutamol delivered with vibrating mesh nebulizer is regarded as high, meriting a score of 3. This assessment was made given that this intervention has been granted approval from phase 4 clinical trials."
Answered by AI
Are participants currently being admitted into this clinical experiment?
"This medical trial is not presently recruiting, as per clinicaltrials.gov data from the October 1st 2023 posting and July 26th 2023 update. Despite this study's inactivity, there are 327 other studies actively seeking patients at present."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger