DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Study to Evaluate Efficacy/Safety of Combination Budesonide/Indacaterol vs Fluticasone/Salmeterol in Patients With COPD

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: Budesonide (Drug); Fluticasone (Drug); Indacaterol (Drug); Salmeterol (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Overall contact:
Novartis Pharmaceuticals, Phone: +41613241111

Summary

To demonstrate the free combination of budesonide and indacaterol is as efficacious as fluticasone and salmeterol in patients with COPD

Clinical Details

Official title: 24-week Study to Evaluate Efficacy and Safety of the Combination Budesonide / Indacaterol vs Fluticasone / Salmeterol in Patients With COPD

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change from baseline in trough Forced Expiratory Volume in 1 second

Secondary outcome:

Change in Health status - mMRC

Percent use of rescue medications

Adverse events

Change from baseline in trough Forced Expiratory Volume in 1 second at week 24

Change in Health status - SGRQ-C

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Written informed consent must be obtained before any assessment is performed

- Outpatients with stable COPD groups C and D according to the 2011 GOLD Guidelines.

- Current or ex-smokers who have a smoking history of at least 10 pack years

- Patients with a history of at least one exacerbation.

- Patients able to read and complete

Exclusion Criteria:

- Use of other investigational drugs within 30 days

- Patients with a history of hypersensitivity to any of the study drugs

- History or current diagnosis of ECG abnormalities

- Patients with diabetes Type I or uncontrolled diabetes Type II including patients

with a history of blood glucose levels consistently outside the normal range

- Patients who have not achieved an acceptable spirometry result at Visit 1

- Patients with a body mass index (BMI) of more than 40 kg/m2

- Patients with lung cancer or a history of lung cancer

- Patients with a history of malignancy of any organ system

- Pregnant or nursing (lactating) women

- Women of child-bearing potential, defined as all women physiologically capable of

becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment

- Patients who do not maintain regular day/night, waking/sleeping cycles (e. g., night

shift workers)

- Patients that are uncontrolled or unstable on permitted therapy, who in the opinion

of the investigator, have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or haematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment

- Patients requiring oxygen therapy for chronic hypoxemia

- Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1

- Patients with concomitant pulmonary disease, e. g. pulmonary tuberculosis,

bronchiectasis, sarcoidosis, interstitial lung disorder or pulmonary hypertension

- Patients with a known diagnosis of Alpha-1 Antitrypsin deficiency.

- Patients with history of lung surgery

- Patients who are participating in the active phase of a supervised pulmonary

rehabilitation program.

- Patients with a history of asthma Other protocol-defined inclusion/exclusion criteria

may apply

Locations and Contacts

Novartis Pharmaceuticals, Phone: +41613241111

Novartis Investigative Site, Buenos Aires 1425, Argentina; Not yet recruiting

Novartis Investigative Site, Buenos Aires C1125ABE, Argentina; Not yet recruiting

Novartis Investigative Site, Salta 4000, Argentina; Not yet recruiting

Novartis Investigative Site, Portoviejo, Ecuador; Not yet recruiting

Novartis Investigative Site, San Pedro Sula, Honduras; Not yet recruiting

Novartis Investigative Site, Tegucigalpa, Honduras; Not yet recruiting

Novartis Investigative Site, Cuenca, Azuay, Ecuador; Not yet recruiting

Novartis Investigative Site, Caba, Buenos Aires C1056ABJ, Argentina; Not yet recruiting

Novartis Investigative Site, Caba, Buenos Aires C1280AEB, Argentina; Not yet recruiting

Novartis Investigative Site, Florida, Buenos Aires B1602DQD, Argentina; Not yet recruiting

Novartis Investigative Site, La Plata, Buenos Aires 1900, Argentina; Not yet recruiting

Novartis Investigative Site, Vicente Lopez, Buenos Aires B1638AAI, Argentina; Not yet recruiting

Novartis Investigative Site, Zarate, Buenos Aires 2800, Argentina; Not yet recruiting

Novartis Investigative Site, Guayaquil, Guayas 412, Ecuador; Not yet recruiting

Novartis Investigative Site, Santa Rosa, La Pampa, Argentina; Not yet recruiting

Novartis Investigative Site, Panama City, Panamá, Panama; Recruiting

Novartis Investigative Site, Panama City, Panamá, Panama; Not yet recruiting

Novartis Investigative Site, Quito, Pichincha 1701, Ecuador; Not yet recruiting

Novartis Investigative Site, Rio de Janeiro, RJ 021941-617, Brazil; Not yet recruiting

Novartis Investigative Site, Rio de Janeiro, RJ 20551-030, Brazil; Not yet recruiting

Novartis Investigative Site, Porto Alegre, RS 90880-480, Brazil; Not yet recruiting

Novartis Investigative Site, Santo Domingo, Republica Dominicana 10205, Dominican Republic; Not yet recruiting

Novartis Investigative Site, Santo Domingo, Republica Dominicana, Dominican Republic; Not yet recruiting

Novartis Investigative Site, São Bernardo do Campo, SP 09750-420, Brazil; Not yet recruiting

Novartis Investigative Site, São Paulo, SP 01244-030, Brazil; Not yet recruiting

Additional Information

Starting date: June 2014
Last updated: May 21, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017