---
title: Exercise Study in Patient With Chronic Obstructive Pulmonary Disease (0000-036)
nct_id: NCT00387036
overall_status: TERMINATED
phase: PHASE2
sponsor: Merck Sharp & Dohme LLC
study_type: INTERVENTIONAL
primary_condition: Chronic Obstructive Pulmonary Disease (COPD)
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00387036.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00387036"
ct_last_update_post_date: 2016-01-21
last_seen_at: "2026-05-12T07:20:57.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Exercise Study in Patient With Chronic Obstructive Pulmonary Disease (0000-036)

**Official Title:** A Multicenter, Double-Blind Placebo-Controlled Crossover Study to Investigate the Effects of an Inhaled Corticosteroid on Cardiopulmonary Exercise Parameters in Patients With Chronic Obstructive Pulmonary Disease

**NCT ID:** [NCT00387036](https://clinicaltrials.gov/study/NCT00387036)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Termininated for business reasons
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 12
- **Lead Sponsor:** Merck Sharp & Dohme LLC
- **Conditions:** Chronic Obstructive Pulmonary Disease (COPD)
- **Start Date:** 2006-12
- **Completion Date:** 2009-07
- **CT.gov Last Update:** 2016-01-21

## Brief Summary

To test the effect of the research study drug, inhaled fluticasone on lung function in exercising patients with Chronic Obstructive Pulmonary Disease (COPD).

## Eligibility

- **Minimum age:** 40 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 40 years and older
* Clinical diagnosis of COPD for greater than one year
* History of cigarette smoking

Exclusion Criteria:

* Other lung diseases (not including COPD), such as asthma
* A condition that could interfere with your ability to perform exercise tests
```

## Arms

- **1** (OTHER) — Arm 1: drug, crossing over to Pbo comparator
- **2** (OTHER) — Arm 2: Pbo comparator, crossing over to drug

## Interventions

- **Fluticasone** (DRUG) — fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment.
- **Comparator: Placebo** (DRUG) — Placebo /inhalation, 2 inhalations bid. 14 Days of treatment.

## Primary Outcomes

- **Standardized Dyspnea Score at Isotime During Exercise** _(time frame: 2 Weeks)_ — Difference in standardized dyspnea rating at isotime during constant load exercise in patients with COPD between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.

Isotime is the duration of the shortest exercise test on all treatment days (or the longest exercise time point common to all constant-load exercise tests). The standardized dyspnea score will be measured with the modified 10-point Borg Scale (0 \[Best\] - 10 \[Worst\] ).

## Secondary Outcomes

- **Exercise Endurance Time** _(time frame: 2 Weeks)_

## Recent Field Changes (last 30 days)

- `armsInterventions.interventions` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00387036.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00387036*  
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