A Multicenter, 4-week Crossover (Total Duration 12 Weeks) to Determine the Impact of QVA149 on Nocturnal Oxygen Levels in Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Multicenter, 4-week Crossover (Total Duration 12 Weeks), Placebo-controlled, Double-blind Study to Determine the Impact of QVA149 (Indacaterol/Glycopyrronium) 85/43 µg on Nocturnal Oxygen Levels in Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02233543
• Other study ID #: CQVA149ANO01
• Status: Completed
• Phase: Phase 4
• Start date: November 30, 2014
• Est. completion date: June 26, 2016

Study information

• Verified date: November 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to determine whether a fixed dose combination of indacaterol and glycopyrronium (QVA149) has an impact on night-time blood oxygen levels in Chronic Obstructive Pulmonary Disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 26, 2016
• Est. primary completion date: June 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of COPD (according to GOLD guidelines, updated 2014) with a post-bronchodilator FEV1/FVC <0.70

• Patients with a post-bronchodilator FEV1 =30% and <60% of the predicted normal value

• Resting daytime oxygen saturation levels measured by pulse oximetry of =95% SpO2

• Smoking history of at least 10 pack years (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years)

Exclusion Criteria:

• An exacerbation of COPD (treatment with oral or parenteral antibiotics and/or glucocorticosteroids and/or hospitalization related to COPD) within 4 weeks prior to screening or during the run-in period

• Diagnosed asthma

• Patients receiving regular long term oxygen therapy (LTOT)

• Ongoing / planned rehabilitation during the study period

• Three or more awakenings during the night leading to toilet visit or other reasons for exiting the bed during the last week prior to the screening visit due to non-COPD reasons

Other protocol-defined inclusion/exclusion criteria may apply.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• QVA149
Delivered once daily via single-dose dry powder inhaler
• QVA149 Placebo
Placebo delivered once daily via single-dose dry powder inhaler

Locations

Country	Name	City	State
Denmark	Novartis Investigative Site	Aarhus
Denmark	Novartis Investigative Site	Hvidovre
Norway	Novartis Investigative Site	Bergen
Sweden	Novartis Investigative Site	Goteborg
Sweden	Novartis Investigative Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Denmark,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Night-time Blood Oxygenation	The mean night-time blood oxygenation following 4 weeks administration of QVA149 compared to placebo was assessed. Night time oxygenation (SpO2) was measured using polygraphy.	Post 4 weeks administration of QVA149, post 4 weeks administration of placebo
Secondary	Percent of Time Spent During the Night Below 90 % in Blood Oxygen Saturation	The time during the night spent below 90 % in blood oxygen saturation following 4 weeks administration of QVA149 compared to placebo was assessed. Night time oxygenation (SpO2) was measured using polygraphy.	Post 4 weeks administration of QVA149, post 4 weeks administration of placebo