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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by McMaster University
Sponsor:
Information provided by (Responsible Party):
John Goffin, McMaster University
ClinicalTrials.gov Identifier:
NCT01172925
First received: July 22, 2010
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
NSCLC
Dyspnea
Drug: Tiotropium
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Phase II Crossover Study of Tiotropium For Dyspnea in Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 12 question Cancer Dyspnea Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 10 point Dyspnea numeric scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • 10 point Cough scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Forced Expiratory Volume 1 second (L/s) and Forced Vital Capacity (L) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: November 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tiotropium
Inhaler
Drug: Tiotropium
Inhaler
Placebo Comparator: Placebo
Inhaler
Drug: Placebo
Inhaler

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172925

Contacts
Contact: John Goffin, MD 905-387-9495 ext 64603 john.goffin@jcc.hhsc.ca
Contact: Heather Harris, RN 905-387-9495 ext 64407 heather.harris@jcc.hhsc.ca

Locations
Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Heather Harris, RN    905-387-9495 ext 64407    heather.harris@jcc.hhsc.ca   
Principal Investigator: John Goffin, MD         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: John Goffin, MD Juravinski Cancer Centre and McMaster University
  More Information

Additional Information:
No publications provided

Responsible Party: John Goffin, Associate Prof, McMaster University
ClinicalTrials.gov Identifier: NCT01172925     History of Changes
Other Study ID Numbers: 2009-TIDAL
Study First Received: July 22, 2010
Last Updated: November 11, 2013
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
NSCLC
dyspnea
phase II
crossover
tiotropium

Additional relevant MeSH terms:
Dyspnea
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial 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
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014