Efficacy and Safety Study of Formoterol/Fluticasone and Salmeterol/Fluticasone in Patients With Moderate-to-severe COPD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Ache Laboratorios Farmaceuticos S.A..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier:
NCT01393145
First received: March 9, 2011
Last updated: July 12, 2011
Last verified: July 2011
  Purpose

A study multicenter, phase III, randomized, open label study to evaluate the efficacy and safety of a fixed-dose combination of formoterol/fluticasone and salmeterol/fluticasone in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) that will enroll 336 subjects aged ≥ 40 years, smokers or former smokers, diagnosed with chronic obstructive pulmonary disease, classified as moderate chronic obstructive pulmonary disease or severe according to GOLD spirometric classification. The subjects will be allocated in 2 parallel groups and will receive the medicines of study, according of the randomization during a 24-week.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
COPD
Drug: Combination Fluticasone /Formoterol 12/250 μg
Drug: Seretide Diskus (salmeterol/fluticasone) 50/250 μg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Phase III, Randomized, Open Label Study to Evaluate the Efficacy and Safety of a Fixed-dose Combination of Formoterol/Fluticasone and Salmeterol/Fluticasone in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD).

Resource links provided by NLM:


Further study details as provided by Ache Laboratorios Farmaceuticos S.A.:

Primary Outcome Measures:
  • Changes in pre-bronchodilator forced expiratory volume in first second (FEV1) [ Time Frame: Comparative between baseline and week 24 ] [ Designated as safety issue: No ]
    Changes of lung function parameter


Secondary Outcome Measures:
  • Changes in forced expiratory volume in first second, without bronchodilator [ Time Frame: Week 0, 8, 16 and 24 ] [ Designated as safety issue: No ]
    Changes of lung function parameter

  • Safety descriptive about occurence of adverse events, evaluation of results of clinical/physical examination and laboratory tests results [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: Yes ]
    Collection of safety data throughout the whole study period

  • Changes in COPD Assessment Test (CAT) [ Time Frame: Week 0, 8, 16 and 24 ] [ Designated as safety issue: No ]
    Questionnaire


Estimated Enrollment: 336
Study Start Date: August 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Drug: Combination Fluticasone /Formoterol 12/250 μg
Capsules containing Fumarate formoterol 12 µg + fluticasone propionate 250 µg dry powder for inhalation with aerocaps®
Active Comparator: Group 2 Drug: Seretide Diskus (salmeterol/fluticasone) 50/250 μg
Capsules containing salmeterol xinafoate 72.5 µg (equivalent to 50 µg of salmeterol) presented as powder for aspiration, packed in a plastic device in disk format, containing 60 doses

  Eligibility

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

Inclusion Criteria:

  1. Age ≥ 40 years;
  2. Chronic obstructive pulmonary disease classified as moderate or severe according to GOLD guidelines (Global Initiative for Chronic Obstructive Lung Disease), with post-bronchodilator FEV1/FVC <0.70, and post-bronchodilator FEV1 <80% and ≥ 30% predicted;
  3. Understanding and capacity to give written consent;
  4. Smoker or ex-smoker of ≥ 10 pack-years [number of pack-years = number of daily cigarettes / 20 x number of years of smoking (eg t10 pack-years is equal to 20 cigarettes / day for 10 years, or 10 cigarettes per day within 20 years)].
  5. Ability to fill out the patient's Diary
  6. Ability to fill out the MRC dyspnea scale and questionnaires CAT and CDLM.

Exclusion Criteria:

  1. Presence of clinically associate morbidities manifested according to the investigator that would interfere in the evaluation, for example: diabetes mellitus, congestive heart failure, coronary heart disease, chronic renal failure, liver failure, arrhythmia, hypothyroidism or hyperthyroidism;
  2. Presence of neuro-psychiatric disorders of any kind;
  3. Presence of mental retardation of any etiology;
  4. Presence of pulmonary malformations, bronchiectasis, cystic fibrosis, bronchopulmonary hemosiderosis, ciliary dyskinesia, alveolitis, hypersensitivity, pulmonary vasculitis, sarcoidosis, tuberculosis or other lung diseases that might interfere with study assessments, as the investigator's discretion;
  5. Subjects using immunosuppressive therapy, immunomodulatory agents, chemotherapy for allergy or any other immunotherapy;
  6. Subjects using xanthine or acebrophylline;
  7. Use within two months preceding the screening visit (V-2) of: anti-leukotrienes, immunoglobulins (including omalizumab), beta blockers, digitalis, itraconazole, amiodarone, antidepressants, monoamine oxidase inhibitors, tricyclic antidepressants, rifampin, oral contraceptives and coumarin ;
  8. Current diagnosis of asthma;
  9. Symptomatic coronary insufficiency;
  10. Surgery for lung volume reduction and / or lung transplantation;
  11. Need for long-term oxygen therapy (defined as the need for oxygen therapy ≥ 12 hours / day);
  12. Pregnant or test β-HCG serum positive;
  13. Lactating women;
  14. Subject who uses more than 2 alcohol drinks a day or> 14 drinks a week;
  15. Subject with a history of malignancy or ≤ 5 years> 5 years, but without documentation of remission / cure.
  16. Illiterate or individuals who have limitation in understanding the use of devices as well as an inability to understand the questionnaires and diary that will be applied; Exception: subject illiterate, but capable of understanding regarding the use of the device, the questionnaires and diaries of the study and make available for relatives who can fill the diary study.
  17. History of hypersensitivity to study drugs and rescue;
  18. Any other disease or therapy that in the opinion of the investigator would jeopardize the subject or interfere with the objective of the study;
  19. Subject with a history of ineffectiveness of formoterol fumarate, to fluticasone or salmeterol xinafoate;
  20. Subject who participated in another study within 1 (one) year;
  21. Pregnant women or those with positive serum β-HCG;
  22. Radiological change is not compatible with COPD;
  23. Clinically significant ECG changes, as reported by the investigator;
  24. Any other disease, therapy or laboratory abnormality which in the opinion of the investigator would jeopardize the subject or interfere with the objective of the study;
  25. Use of medications prescribed in the exclusion criteria for visit V -2.
  26. Subjects who had an exacerbation during the standardization that required systemic corticosteroids and / or antibiotics or hospitalization will not be eligible for randomization.
  27. Use of oral corticosteroids, anti-leukotrienes, immunoglobulins (including omalizumab), beta blockers, digitalis, amiodarone, itraconazole, antidepressants, monoamine oxidase inhibitors and tricyclic antidepressants during the period of standardization;
  28. Any other disease or therapy that in the opinion of the investigator would jeopardize the subject or interfere with the objective of the study
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dr. Carla Peron / Medical Manager of Clinical Trials, Aché Laboratórios Farmaceuticos SA
ClinicalTrials.gov Identifier: NCT01393145     History of Changes
Other Study ID Numbers: ACH-LLN-03(06/10)
Study First Received: March 9, 2011
Last Updated: July 12, 2011
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

Keywords provided by Ache Laboratorios Farmaceuticos S.A.:
Chronic obstructive pulmonary disease (COPD)
salmeterol
fluticasone
formoterol
FEV1
Moderate-to-severe

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Formoterol
Salmeterol
Fluticasone
Fluticasone, salmeterol drug combination
Bronchodilator Agents
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
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics

ClinicalTrials.gov processed this record on August 18, 2014