Add-on Effects of Tiotropium Over Formoterol in Exercise Tolerance on Chronic Obstructive Pulmonary Disease Patients

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00680056
First received: May 15, 2008
Last updated: January 12, 2010
Last verified: October 2009
  Purpose

The primary objective is to comparatively evaluate the isolated effects of a long-acting beta2-adrenergic (formoterol fumarate 12µg b.i.d. via Aeroliser) and combined with a long-acting anti-cholinergic (tiotropium bromide 18µg o.d via Handihaler) on breathlessness, dynamic hyperinflation and exercise tolerance in patients with advanced, but stable, chronic obstructive pulmonary disease. The study hypothesis is that combining long acting bronchodilators with different action mechanisms would promote synergistic effects on clinical outcomes.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Chronic Bronchitis
Pulmonary Emphysema
Drug: Formoterol plus Placebo (Tiotropium)
Drug: Formoterol plus Tiotropium
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Cross-over Study to Compare the Effect of Formoterol Plus Tiotropium Versus Formoterol Monotherapy on Breathlessness, Dynamic Hyperinflation and Exercise Tolerance in Moderate-to-severe Stable COPD Patients

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Percentage Change in Exercise Tolerance From Baseline at 2 Weeks [ Time Frame: Baseline and after 2 weeks with each treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Score on the Transitional Dyspnea Index (TDI) [ Time Frame: After 2 week of each treatment ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: November 2007
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Formoterol plus Placebo (Tiotropium)
Drug: Formoterol plus Placebo (Tiotropium)
Formoterol 12mcg-capsules (2x/d) + Placebo (Tiotropium) (1x/d). Double-blind medication will be dispensed in HandiHalers and Aerolisers during 2 weeks.
Other Name: Formoterol plus Placebo (Tiotropium)
Experimental: 2
Formoterol plus Tiotropium
Drug: Formoterol plus Tiotropium
Formoterol 12mcg-capsule (2x/dia) + Tiotropium 18mcg-capsule (1x/d). Double-blind medication will be dispensed in HandiHalers and Aerolisers during 2 weeks.
Other Name: Formoterol plus Tiotropium

Detailed Description:

This will be a single center, randomized, double-blind study consisting of two 2-week treatment periods separated by a 5-7 days washout phase without long-acting bronchodilators. Eligible patients who complete the one week screening phase will be randomized to one of two treatment sequences: 1) Formoterol --> Formoterol + Tiotropium or 2) Formoterol + Tiotropium --> Formoterol. During the treatment periods, patients will be allowed to use a short-acting beta2-adrenergic+short-acting anticholinergic as rescue medication (salbutamol+ipratropium via MDI)

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COPD patients aged ≥ 40 years with stable moderate-to-severe airflow obstruction (FEV1 < 70% and FEV1/FVC ≤ 70% of predicted normal value) post-bronchodilator
  • presenting with a long history of smoking (> 20 pack-years) and chronic breathlessness (Baseline Dyspnoea Index total score < 9)

Exclusion Criteria:

  • significant cardiovascular disease, hospitalization for COPD exacerbation or presence of a respiratory tract infection within 1 month of screening
  • current or childhood asthma
  • a history of allergic rhinitis or other atopic disease
  • inability to interrupt usual bronchodilator medication
  • use of oral steroids within a month before screening
  • need for long-term oxygen therapy, arterial oxygen saturation < 85% at rest anemia, hypo- and hyperthyroidism, hyperadrenergic state
  • uncontrolled insulin dependent diabetes mellitus, malignancy, or any disease or condition which limits exercise performance other than COPD
  • change in inhaled corticosteroid or theophylline use within 1 month prior to screening
  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: NCT00680056

Locations
Brazil
Pulmonary Function and Clinical Exercise Physiology Unit (SEFICE)
Sao Paulo, Brazil, 04020-050
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: J Alberto Neder, MD, phD Federal University of Sao Paulo
  More Information

No publications provided by Federal University of São Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: J Alberto Neder, Federal University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00680056     History of Changes
Other Study ID Numbers: TIOFOR
Study First Received: May 15, 2008
Results First Received: January 26, 2009
Last Updated: January 12, 2010
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Pulmonary Disease, Chronic Obstructive
Tiotropium
Formoterol
Bronchodilator Agents
Exercise Tolerance
Randomized Controlled Trial [Publication Type]
COPD

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Chronic Disease
Emphysema
Pulmonary Emphysema
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Bronchodilator Agents
Formoterol
Tiotropium
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014