Study of a Tiotropium Inhaler For Shortness of Breath in Advanced Non-Small Cell Lung Cancer (TIDAL)
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ClinicalTrials.gov Identifier: NCT01172925 |
Recruitment Status
: Unknown
Verified May 2015 by John Goffin, McMaster University.
Recruitment status was: Recruiting
First Posted
: July 30, 2010
Last Update Posted
: May 27, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
NSCLC Dyspnea | Drug: Tiotropium Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 34 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized Phase II Crossover Study of Tiotropium For Dyspnea in Advanced Non-Small Cell Lung Cancer |
Study Start Date : | November 2010 |
Estimated Primary Completion Date : | June 2016 |
Estimated Study Completion Date : | August 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Tiotropium
Inhaler
|
Drug: Tiotropium
Inhaler
|
Placebo Comparator: Placebo
Inhaler
|
Drug: Placebo
Inhaler
|
- 12 question Cancer Dyspnea Scale [ Time Frame: 6 weeks ]
- 10 point Dyspnea numeric scale [ Time Frame: 6 weeks ]
- 10 point Cough scale [ Time Frame: 6 weeks ]
- Forced Expiratory Volume 1 second (L/s) and Forced Vital Capacity (L) [ Time Frame: 6 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically proven incurable stage IIIb or stage IV non-small cell lung cancer.
- Dyspnea as defined by a score of 2 or higher on the 10-point Dyspnea Numeric Scale (Appendix 2).
- New dyspnea or worsening dyspnea within the last 6 months per patient reporting.
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172925
Contact: John Goffin, MD | 905-387-9495 ext 64603 | goffinj@hhsc.ca | |
Contact: Sherry McFarlan, RN | 905-387-9495 ext 64407 | smcfarla@hhsc.ca |
Canada, Ontario | |
Juravinski Cancer Centre | Recruiting |
Hamilton, Ontario, Canada, L8V 5C2 | |
Contact: Sherry McFarlan, RN 905-387-9495 ext 64407 smcfarla@hhsc.ca | |
Principal Investigator: John Goffin, MD |
Principal Investigator: | John Goffin, MD | Juravinski Cancer Centre and McMaster University |
Additional Information:
Responsible Party: | John Goffin, Associate Prof, McMaster University |
ClinicalTrials.gov Identifier: | NCT01172925 History of Changes |
Other Study ID Numbers: |
2009-TIDAL |
First Posted: | July 30, 2010 Key Record Dates |
Last Update Posted: | May 27, 2015 |
Last Verified: | May 2015 |
Keywords provided by John Goffin, McMaster University:
NSCLC dyspnea phase II crossover tiotropium |
Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung Dyspnea Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Respiration Disorders Signs and Symptoms, Respiratory |
Signs and Symptoms Tiotropium Bromide Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Parasympatholytics Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |