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

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Chronic Bronchitis, Pulmonary Emphysema

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Formoterol plus Placebo (Tiotropium)

Formoterol plus Tiotropium

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary Disease, Chronic Obstructive, Tiotropium, Formoterol, Bronchodilator Agents, Exercise Tolerance, Randomized Controlled Trial [Publication Type], COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Pulmonary Function and Clinical Exercise Physiology Unit (SEFICE)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

Formoterol plus Placebo (Tiotropium)

Formoterol plus Tiotropium

Outcomes

Primary Outcome Measures

Percentage Change in Exercise Tolerance From Baseline at 2 Weeks

Percentage change from baseline in time to the limit of tolerance on a high intensity constant-speed treadmill exercise test (with a speed corresponding to 80% of that obtained during incremental test)

Secondary Outcome Measures

Mean Score on the Transitional Dyspnea Index (TDI)

TDI is a multidimensional clinical instrument developed to provide a comprehensive assessment of change in dyspnea after an intervention, considering three components (functional impairment, magnitude of task, and magnitude of effort). It ranges from -9 (major deterioration) to +9 (major improvement).

Full Information

NCT ID

NCT00680056

First Posted

May 15, 2008

Last Updated

January 12, 2010

Sponsor

Federal University of São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT00680056

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Federal University of São Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive, Chronic Bronchitis, Pulmonary Emphysema

Keywords

Pulmonary Disease, Chronic Obstructive, Tiotropium, Formoterol, Bronchodilator Agents, Exercise Tolerance, Randomized Controlled Trial [Publication Type], COPD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Formoterol plus Placebo (Tiotropium)

Arm Title

Arm Type

Experimental

Arm Description

Formoterol plus Tiotropium

Intervention Type

Drug

Intervention Name(s)

Formoterol plus Placebo (Tiotropium)

Intervention Description

Formoterol 12mcg-capsules (2x/d) + Placebo (Tiotropium) (1x/d). Double-blind medication will be dispensed in HandiHalers and Aerolisers during 2 weeks.

Intervention Type

Drug

Intervention Name(s)

Formoterol plus Tiotropium

Intervention Description

Formoterol 12mcg-capsule (2x/dia) + Tiotropium 18mcg-capsule (1x/d). Double-blind medication will be dispensed in HandiHalers and Aerolisers during 2 weeks.

Primary Outcome Measure Information:

Title

Percentage Change in Exercise Tolerance From Baseline at 2 Weeks

Description

Time Frame

Baseline and after 2 weeks with each treatment

Secondary Outcome Measure Information:

Title

Mean Score on the Transitional Dyspnea Index (TDI)

Description

Time Frame

After 2 week of each treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

J Alberto Neder, MD, phD

Organizational Affiliation

Federal University of Sao Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pulmonary Function and Clinical Exercise Physiology Unit (SEFICE)

City

Sao Paulo

ZIP/Postal Code

04020-050

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

20580216

Citation

Berton DC, Reis M, Siqueira AC, Barroco AC, Takara LS, Bravo DM, Andreoni S, Neder JA. Effects of tiotropium and formoterol on dynamic hyperinflation and exercise endurance in COPD. Respir Med. 2010 Sep;104(9):1288-96. doi: 10.1016/j.rmed.2010.05.017. Epub 2010 Jun 26.

Results Reference

derived

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

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