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Completed

NCT Number: NCT01033669

Assessment Of The Inhalation Profiles Of Four Dry Powder Inhalers In Patients With Variable Degrees Of Lung Obstruction

Assessment of the inhalation profiles of four dry powder inhalers in patients with variable degrees of lung obstruction

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Key information

Conditions

Asthma Bronchial Diseases Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site

Berlin, 10117, Germany

About this study

Randomized to device sequence

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with a physician documented history or diagnosis of asthma for at least 6 months
  • Reversibility, defined as an increase in FEV1 at the Screening visit of greater than or equal to 12% and 200 mL
  • Subjects with a physician documented history or diagnosis of mild or severe Chronic Obstructive Pulmonary Disease

Exclusion criteria

  • Female subjects who are pregnant
  • Subjects who have a history of life-threatening asthma/COPD or who have experienced two or more exacerbations requiring hospitalization in the 12 months prior to screening
  • Evidence of lower respiratory tract infection
  • Subjects diagnosed with pulmonary fibrosis, bronchiectasis, pneumoconiosis, sarcoidosis or tuberculosis

Treatment and study plan

CRC-749

Device

There is no drug being used. This is a device.

DISKUS

Device

There is no drug being used. This is a device.

Twisthaler

Device

There is no drug being used. This is a device.

Miat Monohaler

Device

There is no drug being used. This is a device.

Primary outcomes

  1. Peak Inspiratory Flow Rate

    Time frame: Day 3-10

Secondary outcomes

  1. Pressure Slope

    Time frame: Day 3-10

  2. Peak Pressure Drop

    Time frame: Day 3-10

  3. Time to Peak Pressure Drop

    Time frame: Day 3-10

  4. Inhaled Volume

    Time frame: Day 3-10

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Randomized Cross-Over Study Investigating The Inhalation Profiles Of Four Dry Powder Inhalation Devices In Subjects With Asthma And Chronic Obstructive Pulmonary Disease.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 16, 2009
Registry last updated
Mar 17, 2010

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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