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O2 Transport and Utilization in Health and Lung Disease

NCT ID: NCT04014712

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2022-08-31

Brief Summary

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Skeletal muscle dysfunction is a frequent and clinically relevant systemic manifestation of Chronic Pulmonary Obstructive Disease (COPD), which is still poorly understood. Therefore, the focus of this study is on the role of a deficit in tetrahydrobiopterin and nitric oxide synthase uncoupling induced by chronic oxidative stress on metabolic and vascular abnormalities in skeletal muscle of patients suffering from COPD.

Detailed Description

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The purpose of this study is to assess the efficacy of supplementation with tetrahydrobiopterin (BH4) for improving vascular and muscle function in patients with COPD and healthy controls.

Conditions

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COPD Tetrahydrobiopterin Deficiency Oxidative Stress

Keywords

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BH4 Exercise Mitochondria Vascular function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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acute BH4/Tetrahydrobiopterin treatment

Oral supplement, Pill, 10 mg/kg of body weight

Group Type EXPERIMENTAL

Tetrahydrobiopterin

Intervention Type DRUG

Oral, Single dose

Placebo

Oral supplement, Pill, Placebo pill with inert excipient

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Single dose

Interventions

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Tetrahydrobiopterin

Oral, Single dose

Intervention Type DRUG

Placebo oral tablet

Single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All subjects must be between the age of 18 and 85 years;
* For the COPD cohort, patients with a diagnosis of stable COPD (i.e., those not experiencing an acute exacerbation of symptoms) and spirometric evidence of airway obstruction (FEV1 \<80% predicted, FEV/FVC\<0.70);
* Ability to perform motor tests;
* Ability to provide informed consent

Exclusion Criteria

* uncontrolled hypertension;
* hyperlipidemia;
* recent exacerbation;
* Major cardiovascular event procedure (\<3 months);
* Pregnancy
* known significant hepatic, renal disease, active substance abuse
* contraindication to MRI, claustrophobia
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Massachusetts, Amherst

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Applied Life Sciences

Amherst, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2018-4815

Identifier Type: -

Identifier Source: org_study_id