Skip to main content
OpenTrials
Completed

NCT Number: NCT02233543

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)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Aarhus, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QVA149

Drug

Delivered once daily via single-dose dry powder inhaler

Other names: indacaterol/glycopyrronium,, Ultibro Breezhaler

QVA149 Placebo

Drug

Placebo delivered once daily via single-dose dry powder inhaler

Primary outcomes

  1. Mean Night-time Blood Oxygenation

    Time frame: Post 4 weeks administration of QVA149, post 4 weeks administration of placebo

    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.

Secondary outcomes

  1. Percent of Time Spent During the Night Below 90 % in Blood Oxygen Saturation

    Time frame: Post 4 weeks administration of QVA149, post 4 weeks administration of placebo

    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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 8, 2014
Registry last updated
Aug 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.