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Proposal 1022

Title of the Proposed Research

Prediction of maximal work load (Wmax)in a bicycle test in patients with COPD.

Lead Researcher

Göran Eriksson

Affiliation

Dept of Respiratory Medicine & Allergology
Lund University Hospital
22185 Lund, Sweden

Funding Source

We have received a non-restricted grant from Sandoz
We have also applied for funds from Region Skane, Sweden

Potential Conflicts of Interest

None

Data Sharing Agreement Date

1 June 2017

Lay Summary

The objective of the whole project is to optimize the protocol for exercise testing in COPD patients. A common appropriate exercise protocol today is endurance time during cycling at 75% of maximum working capacity (Wmax)described by ERS Task Force. Eur Respir J 1997; 10: 2662–268. However, it has high inter- and intra-test variation and large patient materials have been required to ensure results. The aim is evaluate and modify present protocol based on new knowledge and new measures to optimize testing for exercise capacity in patients with mild to severe COPD. This applies both the tests to determine Wmax and the following sub-maximal endurance test at e.g. 75% of Wmax.

The determination of Wmax, which is a per-requisite for a successful preceding endurance test at lower load, can put COPD patients at risk for respiratory and cardiovascular failure. Thus, many protocols for estimating Wmax or Maximal Oxygen Consumption (VO2max)have been developed to avoid putting these patients at risk. Most efforts have done in healthy and patients with cardiovascular disease. Limited efforts have been done in COPD and are primarily based on single or few predictors such as FEV1, heart rate, Weight. No-one has tried to create a multiple algorithm including demography, medical history, static and dynamic lung function, diffusion capacity/oxygen kinetics, symptoms/QoL, cardiovascular parameters and blood biomarkers. A number of improvement steps are planned.

1) Determination of the most important predictors for Wmax in patients with mild to severe COPD. This can be done by analyzing retrospective data of already completed bicycle endurance studies. To investigate measured predictors in a broad COPD population, in sub-groups such as gender and GOLD stages and do validation tests a great number of COPD patients are needed. We hope to collect 500-1000 patients from AstraZeneca, Boeringer-Ingelheim and Novartis. AstraZeneca and Boeringer-Ingelheim have provided 111 and 731 patients, respectively.

2) The predicted Wmax will guide to a proper starting load, loading escalation and time on bicycle to reach the patient's true Wmax, which can shorten the test and thereby increase safety. By adding new measurements we also hope to improve the Wmax prediction model and thereby give better guidance to rehabilitation programs and to clinical trials and the sub-maximal endurance test, where drugs are compared.

3) The ultimate goal is to create a prediction model which is good enough to directly guide rehabilitation programs and the sub-maximal endurance level in clinical trials. By avoiding the Wmax test patient's risks can be decreased and numbers of procedures and visits can be diminished i.e. cost and time can be saved. This may be achieved directly from retrospective data but more likely by adding measures like oxygen kinetics, CV-parameters and biomarkers. These test will be done at our institution.

Study Data Provided

NOVARTIS-CQAB149B2311: A Phase III Randomized, Double-blind, Placebo-controlled, 2-period Crossover, Multicenter Study to Assess the Effect of Indacaterol (300 µg o.d.) on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NOVARTIS-CQVA149A2305: A Randomized, Blinded, Double Dummy, Multi-center, Placebo Controlled, 3 Period, Crossover Study to Assess the Effect of QVA149 (110/50 µg o.d.) on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control.
NOVARTIS-CNVA237A2310: A Multi-center, Randomized, Double-blind, Placebo-controlled, Two-period Cross-over Study to Assess the Effect of 50µg Inhaled NVA237 on Exercise Endurance in Patients With Moderate to Severe COPD

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.