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Bronchodilator
Tiotropium for Non-Small Cell Lung Cancer (TIDAL Trial)
Phase 2
Waitlist Available
Led By John Goffin, MD
Research Sponsored by Hamilton Health Sciences Corporation
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 6 weeks
Awards & highlights
TIDAL Trial Summary
The feeling of shortness of breath is very common in lung cancer. It is uncomfortable for patients and upsetting for their family. Although drugs like morphine and oxygen can help some patients feel better, they don't help everybody, and they are not used in patients with early symptoms. More relief is needed for these patients. The investigators are studying a drug called tiotropium, which is used in emphysema. It is an inhaler that opens the airways to allow easier breathing. Every patient will get the drug but also a placebo, in a random (flip of a coin) order. They will get each for 2 weeks. The investigators will see if they feel better with the drug.
Eligible Conditions
- Non-Small Cell Lung Cancer
- Shortness of Breath
TIDAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
12 question Cancer Dyspnea Scale
Secondary outcome measures
10 point Cough scale
10 point Dyspnea numeric scale
Forced Expiratory Volume 1 second (L/s) and Forced Vital Capacity (L)
Side effects data
From 2018 Phase 4 trial • 76 Patients • NCT030559887%
Chronic obstructive pulmonary disease
3%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fluticasone Propionate + Salmeterol FDC (F+S 1000/100)
Tiotropium + Olodaterol FDC (T+O 5/5)
TIDAL Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TiotropiumExperimental Treatment1 Intervention
Inhaler
Group II: PlaceboPlacebo Group1 Intervention
Inhaler
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tiotropium
FDA approved
Find a Location
Who is running the clinical trial?
Hamilton Health Sciences CorporationLead Sponsor
368 Previous Clinical Trials
300,959 Total Patients Enrolled
John Goffin, MDPrincipal InvestigatorJuravinski Cancer Centre and McMaster University
Frequently Asked Questions
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