Know Cancer

forgot password

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

Phase 2
18 Years
Open (Enrolling)
NSCLC, Dyspnea

Thank you

Trial Information

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

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

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.


Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

12 question Cancer Dyspnea Scale

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

John Goffin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Juravinski Cancer Centre and McMaster University


Canada: Health Canada

Study ID:




Start Date:

November 2010

Completion Date:

January 2012

Related Keywords:

  • Dyspnea
  • dyspnea
  • phase II
  • crossover
  • tiotropium
  • Carcinoma, Non-Small-Cell Lung
  • Dyspnea
  • Lung Neoplasms