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

NCT ID: NCT01033669

Last Updated: 2010-03-17

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Randomized to device sequence

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Pulmonary Disease, Chronic Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dry Powder Inhalers

CRC-749

Intervention Type DEVICE

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

Diskus

Intervention Type DEVICE

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

Twisthaler

Intervention Type DEVICE

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

Miat Monohaler

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CRC-749

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

Intervention Type DEVICE

Diskus

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

Intervention Type DEVICE

Twisthaler

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

Intervention Type DEVICE

Miat Monohaler

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pfizer, Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Berlin, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A9011071

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Inhalation Flow Rate-study
NCT02563197 COMPLETED PHASE1