Study of a Tiotropium Inhaler For Shortness of Breath in Advanced Non-Small Cell Lung Cancer (TIDAL)

Randomized Phase II Crossover Study of Tiotropium For Dyspnea in Advanced Non-Small Cell Lung Cancer

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.

Study Overview

• Status: Unknown
• Conditions: NSCLC; Dyspnea
• Intervention / Treatment: Drug: Tiotropium; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Recruiting
      • Juravinski Cancer Centre
      • Contact: Sherry McFarlan, RN; Phone Number: 64407 905-387-9495; Email: smcfarla@hhsc.ca
      • Principal Investigator: John Goffin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Histologically or cytologically proven incurable stage IIIb or stage IV non-small cell lung cancer.
2. Dyspnea as defined by a score of 2 or higher on the 10-point Dyspnea Numeric Scale (Appendix 2).
3. New dyspnea or worsening dyspnea within the last 6 months per patient reporting.

Exclusion Criteria:

1. Age < 18.
2. An FEV1 / FVC ratio < 0.7 with an FEV1 of < 80% predicted post-bronchodilator.
3. Life expectancy < 3 months.
4. Significant worsening of dyspnea over the last week such that an acute cardiac or respiratory condition is considered likely (e.g. pneumonia, heart failure).
5. Myocardial infarction within the previous month.
6. Heart rate ≥ 120.
7. Active tuberculosis or tuberculosis receiving antibiotic therapy.
8. Current or previous use of ipratropium, tiotropium, or oxitropium (see Appendix 6).
9. Sensitivity to atropine.
10. Pre-existing diagnosis of asthma or moderate to severe Chronic Obstructive Pulmonary Disease
11. Use of beta-adrenergic bronchodilators more than once per week.
12. Use of experimental therapy with known cholinergic or adrenergic effects.
13. Uncontrolled glaucoma.
14. Urinary retention.
15. An active upper or lower respiratory infection or having taken antibiotics for any recent respiratory infection within 4 weeks.
16. Symptomatic pleural or pericardial effusion.
17. Evidence of reversible proximal endobronchial obstruction.
18. Oxygen saturation < 90%.
19. A hemoglobin of < 100 g/litre. Testing is to be within 4 weeks of randomization.
20. Calculated or urine creatinine clearance ≤ 50 mL/min (see Appendix 5 for calculation). Testing it to be within 4 weeks of randomization.
21. Weight loss > 10% of usual body weight within 6 months.
22. Known pregnancy or lactating.

23. Unable to independently fill out quality of life forms or give informed consent.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tiotropium; Inhaler	Drug: Tiotropium; Inhaler
Placebo Comparator: Placebo; Inhaler	Drug: Placebo; Inhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
12 question Cancer Dyspnea Scale	6 weeks

Secondary Outcome Measures

Outcome Measure	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)	6 weeks

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: John Goffin, MD, Juravinski Cancer Centre and McMaster University

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: July 22, 2010
• First Submitted That Met QC Criteria: July 29, 2010
• First Posted (Estimate): July 30, 2010

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 22, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: NSCLC; phase II; crossover; dyspnea; tiotropium
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide
• Other Study ID Numbers: 2009-TIDAL