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

NCT01172925 | Unknown Phase 2 DMC

• 1 other identifier: 2009-TIDAL
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

NSCLC; Dyspnea

Keywords

NSCLC; dyspnea; phase II; crossover; tiotropium

Outcome Measures

Primary Outcomes (1)

• 12 question Cancer Dyspnea Scale

  6 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

Tiotropium

EXPERIMENTAL

Inhaler

Drug: Tiotropium

Placebo

PLACEBO COMPARATOR

Inhaler

Drug: Placebo

Interventions

Tiotropium DRUG

Inhaler

Tiotropium

Placebo DRUG

Inhaler

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

RECRUITING

MeSH Terms

Conditions

Dyspnea

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• John Goffin, MD

  Juravinski Cancer Centre and McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Goffin, MD

CONTACT

905-387-9495; goffinj@hhsc.ca

Sherry McFarlan, RN

CONTACT

905-387-9495; smcfarla@hhsc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: July 30, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

CA (1)