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NCT00984659 · ClinicalTrials.gov registry record · Phase 4

Validation of a New Shortness of Breath With Daily Activities Questionnaire in Patients With Chronic Obstructive Pulmonary Disease

A Phase 4 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 4
Development phase
366
Enrollment target

NCT00984659: Completed Phase 4 study, sponsored by GlaxoSmithKline.

NCT00984659 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 366 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00984659, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 4
Development phase
366 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate a new questionnaire to capture the patient experience of COPD. The information collected will be used to validate the Shortness of Breath with Daily Activities Questionnaire.

Primary Outcome

Cronbach's alpha (CA) is a measure of the IC of the 13-item SOBDA questionnaire (completed via electronic diary by a sample of participants). It is the ratio of the variance (var.) of the sum of the individual scores and the var. of the total score. The var. of the sum of a group of independent variables is the sum of their var.; thus, if the variables are positively correlated, the var. of the sum will be increased. If the items making up the score are identical and so perfectly correlated, CA=

Interventions

  • DRUG Placebo
  • DRUG Salmeterol
  • DRUG Fluticasone propionate/salmeterol combination product

Trial Details

FieldValue
Enrollment Target 366 participants
Start Date 2009-10-29
Est. Completion 2010-07-01
Phase Phase 4
GlaxoSmithKline

1,345 total trials

What the finished NCT00984659 record still lists

NCT00984659 is an interventional study that assigns participants to a tested intervention. The registered 366 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (29% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00984659 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00984659 about?

NCT00984659 is a clinical study titled "Validation of a New Shortness of Breath With Daily Activities Questionnaire in Patients With Chronic Obstructive Pulmonary Disease". The purpose of this study is to evaluate a new questionnaire to capture the patient experience of COPD. The information collected will be used to validate the Shortness of Breath with Daily Activities Questionnaire.

What is the current status of trial NCT00984659?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 366 participants. The study started on 2009-10-29. Estimated completion is 2010-07-01.

What interventions are being tested in trial NCT00984659?

The interventions under investigation include: Placebo (DRUG), Salmeterol (DRUG), Fluticasone propionate/salmeterol combination product (DRUG).

Who is sponsoring clinical trial NCT00984659?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00984659's enrollment target sits among peer trials

366 225th of 2000 higher than 1,776 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00984659, the US trial registry maintained by the National Library of Medicine. NCT00984659 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.