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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium | Experimental | Inhaler |
|
| Placebo | Placebo Comparator | Inhaler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium | Drug | Inhaler |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 12 question Cancer Dyspnea Scale | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 10 point Dyspnea numeric scale | 6 weeks | |
| 10 point Cough scale | 6 weeks | |
| Forced Expiratory Volume 1 second (L/s) and Forced Vital Capacity (L) |
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Inclusion Criteria:
Exclusion Criteria:
Age < 18.
An FEV1 / FVC ratio < 0.7 with an FEV1 of < 80% predicted post-bronchodilator.
Life expectancy < 3 months.
Significant worsening of dyspnea over the last week such that an acute cardiac or respiratory condition is considered likely (e.g. pneumonia, heart failure).
Myocardial infarction within the previous month.
Heart rate ≥ 120.
Active tuberculosis or tuberculosis receiving antibiotic therapy.
Current or previous use of ipratropium, tiotropium, or oxitropium (see Appendix 6).
Sensitivity to atropine.
Pre-existing diagnosis of asthma or moderate to severe Chronic Obstructive Pulmonary Disease
Use of beta-adrenergic bronchodilators more than once per week.
Use of experimental therapy with known cholinergic or adrenergic effects.
Uncontrolled glaucoma.
Urinary retention.
An active upper or lower respiratory infection or having taken antibiotics for any recent respiratory infection within 4 weeks.
Symptomatic pleural or pericardial effusion.
Evidence of reversible proximal endobronchial obstruction.
Oxygen saturation < 90%.
A hemoglobin of < 100 g/litre. Testing is to be within 4 weeks of randomization.
Calculated or urine creatinine clearance ≤ 50 mL/min (see Appendix 5 for calculation). Testing it to be within 4 weeks of randomization.
Weight loss > 10% of usual body weight within 6 months.
Known pregnancy or lactating.
Unable to independently fill out quality of life forms or give informed consent.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John Goffin, MD | Contact | 905-387-9495 | 64603 | goffinj@hhsc.ca |
| Sherry McFarlan, RN | Contact | 905-387-9495 | 64407 | smcfarla@hhsc.ca |
| Name | Affiliation | Role |
|---|---|---|
| John Goffin, MD | Juravinski Cancer Centre and McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juravinski Cancer Centre | Recruiting | Hamilton | Ontario | L8V 5C2 | Canada |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Drug |
Inhaler |
|
| 6 weeks |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |