A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB in Patients With COPD Who Have Moderate to Severe Airflow Limitation

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB in Patients With COPD Who Have Moderate to Severe Airflow Limitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682863
• Other study ID #: CQVA149A2340
• Secondary ID: 2012-001998-93
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2012
• Last updated: January 2, 2015
• Start date: October 2012
• Est. completion date: June 2014

Study information

• Verified date: January 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is to assess the safety and tolerability of two different dose levels of QVA149

Recruitment information / eligibility

• Status: Completed
• Enrollment: 614
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Male or female patients with COPD according to GOLD 2011 who have signed informed consent.

2. Patients with airflow limitation of 30-80% post-bronchodilator FEV1 at run-in.

3. Current or ex-smokers with a smoking history of at least 10 packs years.

4. Patients with a mMRC score of at least 2 at run-in.

Exclusion Criteria:

1. Patients contraindicated for muscarinic antagonist agents and beta-2 agonists. 11. Patients with a history of malignancy of any organ system, treated or untreated, within the last five years.

2. Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention.

3. Patients who had a COPD exacerbation within 6 weeks prior to screening.

4. Patients who have a respiratory tract infection within 4 weeks prior to screening.

5. Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.

6. Patients with a history of asthma.

7. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to age 40 years.

8. Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.

9. Patients with concomitant pulmonary disease.

10. Patients with a history of certain cardiovascular co-morbid conditions

11. Patients with a diagnosis of alpha-1 anti-trypsin deficiency.

12. Patients with active pulmonary tuberculosis.

13. Patients in the active phase of a pulmonary rehabilitation programme.

14. Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• QVA149
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
• Long acting b2-agonist
QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI
• QVA149
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
• Placebo
To mimic QAB149

Locations

Country	Name	City	State
Bulgaria	Novartis Investigative Site	Pleven
Bulgaria	Novartis Investigative Site	Plovdiv
Bulgaria	Novartis Investigative Site	Ruse
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Varna
Finland	Novartis Investigative Site	Helsinki
Finland	Novartis Investigative Site	HUS
Finland	Novartis Investigative Site	Pori
Finland	Novartis Investigative Site	Turku
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Gyor
Hungary	Novartis Investigative Site	Mako
Hungary	Novartis Investigative Site	Nyiregyhaza
Hungary	Novartis Investigative Site	Pecs
Hungary	Novartis Investigative Site	Szazhalombatta
Hungary	Novartis Investigative Site	Szolnok
Hungary	Novartis Investigative Site	Torokbalint
Puerto Rico	Novartis Investigative Site	Barceloneta
Puerto Rico	Novartis Investigative Site	San Juan
Puerto Rico	Novartis Investigative Site	San Juan
Romania	Novartis Investigative Site	Brasov
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Bucharest	District 1
Romania	Novartis Investigative Site	Bucharest	District 1
Romania	Novartis Investigative Site	Bucharest	District 3
Romania	Novartis Investigative Site	Bucharest	District 3
Romania	Novartis Investigative Site	Bucuresti
Romania	Novartis Investigative Site	Cluj-Napoca
Romania	Novartis Investigative Site	Constanta	Jud. Constanta
Romania	Novartis Investigative Site	Iasi	Jud. Iasi
Spain	Novartis Investigative Site	Badalona	Cataluña
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Canet de Mar	Cataluña
Spain	Novartis Investigative Site	Centelles	Cataluña
Spain	Novartis Investigative Site	Granada	Andalucia
Spain	Novartis Investigative Site	Málaga	Andalucia
Spain	Novartis Investigative Site	Tarragona	Cataluña
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
United States	Novartis Investigative Site	Abingdon	Virginia
United States	Novartis Investigative Site	Ames	Iowa
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Bangor	Maine
United States	Novartis Investigative Site	Boulder	Colorado
United States	Novartis Investigative Site	Bowling Green	Kentucky
United States	Novartis Investigative Site	Corsicana	Texas
United States	Novartis Investigative Site	Dayton	Ohio
United States	Novartis Investigative Site	Dublin	Ohio
United States	Novartis Investigative Site	Eugene	Oregon
United States	Novartis Investigative Site	Evansville	Indiana
United States	Novartis Investigative Site	Ft. Worth	Texas
United States	Novartis Investigative Site	Henderson	Nevada
United States	Novartis Investigative Site	Honolulu	Hawaii
United States	Novartis Investigative Site	Huntington Beach	California
United States	Novartis Investigative Site	Iowa City	Iowa
United States	Novartis Investigative Site	Jackson	Mississippi
United States	Novartis Investigative Site	Knoxville	Tennessee
United States	Novartis Investigative Site	Lakewood	California
United States	Novartis Investigative Site	Las Vegas	Nevada
United States	Novartis Investigative Site	Lincoln	Nebraska
United States	Novartis Investigative Site	Livonia	Michigan
United States	Novartis Investigative Site	Lombard	Illinois
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Lufkin	Texas
United States	Novartis Investigative Site	McKinney	Texas
United States	Novartis Investigative Site	Medford	Oregon
United States	Novartis Investigative Site	Midlothian	Virginia
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	Missoula	Montana
United States	Novartis Investigative Site	New Orleans	Louisiana
United States	Novartis Investigative Site	Newport News	Virginia
United States	Novartis Investigative Site	O'Fallon	Illinois
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Orange	California
United States	Novartis Investigative Site	Peoria	Illinois
United States	Novartis Investigative Site	Picayune	Mississippi
United States	Novartis Investigative Site	Rochester	New York
United States	Novartis Investigative Site	Slidell	Louisiana
United States	Novartis Investigative Site	Spartanburg	South Carolina
United States	Novartis Investigative Site	St. Charles	Missouri
United States	Novartis Investigative Site	Stockton	California
United States	Novartis Investigative Site	Vestavia	Alabama
United States	Novartis Investigative Site	Walnut Creek	California
United States	Novartis Investigative Site	Waterloo	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Bulgaria,  Finland,  Hungary,  Puerto Rico,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall adverse event reporting rate	The overall rate of adverse events reported from initiation through 30 days post last dose.	56 weeks	Yes
Secondary	ECG	ECG	52 weeks	Yes
Secondary	Time to discontinuation		52 weeks	Yes
Secondary	Forced expiratory volume in 1 second		52 weeks	No
Secondary	Forced expiratory volume in 1 second at all post-baseline time points		52 weeks	No
Secondary	Time to first exacerbation		52 weeks	No
Secondary	Symptoms reported over the 52 week period		52 weeks	No
Secondary	Number of puffs of rescue medication over the 52 week period		52 weeks	No
Secondary	Forced vital capacity at all post-baseline time points		52 weeks	No
Secondary	Blood pressure	Systolic and diastolic blood pressure	52 weeks	Yes
Secondary	Laboratory evaluations	Blood hematology and blood chemistry	52 weeks	Yes