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OpenTrials
Completed

NCT Number: NCT00274534

A Comparison of the Effects of Tiotropium Inhalation qd and Salmeterol Inhalation Bid on Arterial Blood Gases.

To evaluate changes in PaO2 following inhalation of Tiotropium by HandiHaler compared to Salmeterol MDI in patients with moderate to severe COPD.

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hines Veterans Administration Hospital, Hines, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Treatment and study plan

Tiotropium

Drug

Salmeterol

Drug

Primary outcomes

  1. The change from baseline (Visit 2) in the PaO2 area under the curve (AUC) for the time period 0 to 105 minutes obtained through arterial blood gases (ABGs) at the end of each treatment period.

    Time frame: up to day 90

Secondary outcomes

  1. Maximum decline in PaO2 from baseline

    Time frame: up to day 90

  2. Maximum increase in alveolar-arterial oxygen gradient from baseline

    Time frame: up to day 90

  3. Change from baseline (Visit 2) in FEV1 prior to insertion of catheter and 15 minutes post removal of catheter

    Time frame: up to day 90

  4. Change from baseline (Visit 2) in FVC prior to insertion of catheter and 15 minutes post removal of catheter

    Time frame: up to day 90

  5. Rescue medication use

    Time frame: up to day 90

  6. COPD symptom score

    Time frame: up to day 90

  7. Occurrence of adverse events

    Time frame: up to day 90

  8. Pulse rate and sitting blood pressure in conjunction with spirometry

    Time frame: up to day 90

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Comparison of the Effects of Tiotropium (18 Mcg) Inhalation Capsule q.d. and Salmeterol (50 Mcg) Inhalation Aerosol b.i.d. on Arterial Blood Gases in a Double-blind, Double-dummy, 4-week Crossover Study in Patients With Chronic Obstructive Pulmonary Disease (COPD).

Important dates

Study start
2000
Study completion
2003
First posted
Jan 11, 2006
Registry last updated
Nov 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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