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)

NCT02233543 | Completed Phase 4 Results

• 1 other identifier: CQVA149ANO01
• Study Type: interventional
• Target: 38
• Locations: 3 countries
• Sites: 5

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; QVA149; nocturnal oxygen levels; combination bronchodilator

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Post 4 weeks administration of QVA149, post 4 weeks administration of placebo

Study Arms (2)

First QVA149 (indacaterol/glycopyrronium), then Placebo

EXPERIMENTAL

Participants received 4 weeks of QVA149 85/43 μg delivered dose once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day followed by 2 weeks washout. Then participants received 4 weeks of placebo once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day.

Drug: QVA149; Drug: QVA149 Placebo

First Placebo, then QVA149 (indacaterol/glycopyrronium)

EXPERIMENTAL

Participants received 4 weeks of placebo once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day followed by 2 weeks washout. Then participants received 4 weeks of QVA149 85/43 μg delivered dose once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day.

Drug: QVA149; Drug: QVA149 Placebo

Interventions

QVA149 DRUG

Delivered once daily via single-dose dry powder inhaler

Also known as: indacaterol/glycopyrronium,, Ultibro Breezhaler

First Placebo, then QVA149 (indacaterol/glycopyrronium); First QVA149 (indacaterol/glycopyrronium), then Placebo

QVA149 Placebo DRUG

Placebo delivered once daily via single-dose dry powder inhaler

First Placebo, then QVA149 (indacaterol/glycopyrronium); First QVA149 (indacaterol/glycopyrronium), then Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (5)

Novartis Investigative Site

Aarhus, 8000 C, Denmark

Location

Novartis Investigative Site

Hvidovre, 2650, Denmark

Location

Novartis Investigative Site

Bergen, -N5021, Norway

Location

Novartis Investigative Site

Gothenburg, 413 45, Sweden

Location

Novartis Investigative Site

Uppsala, SE-751 85, Sweden

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol-glycopyrronium combination; indacaterol; Glycopyrrolate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: September 8, 2014
• Study Start: November 30, 2014
• Primary Completion: June 26, 2016
• Study Completion: June 26, 2016
• Last Updated: August 6, 2018
• Results First Posted: August 6, 2018

Record last verified: 2017-11

Locations

DK (2); NO (1); SE (2)