Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101)

This study has been completed.

Study NCT00306163 Information provided by ALTANA Pharma

First Received on March 22, 2006. Last Updated on April 6, 2010 History of Changes

Results First Received: April 6, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	Asthma
Interventions:	Drug: Ciclesonide Drug: Fluticasone

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 101 subjects gave Informed Consent. 64 subjects did not enter or discontinued the study due to various reasons.

Reporting Groups

	Description
Ciclesonide	160 µg, once daily
Fluticasone	100 µg, twice daily

Participant Flow: Overall Study

	Ciclesonide	Fluticasone
STARTED	19	18
COMPLETED	19	18
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Ciclesonide	160 µg, once daily
Fluticasone	100 µg, twice daily

Baseline Measures

	Ciclesonide	Fluticasone	Total
Number of Participants [units: participants]	19	18	37
Age ^[1] [units: years] Median ( Inter-Quartile Range )	39.61 ( 32.54 to 46.64 )	46.02 ( 37.85 to 55.52 )	42.25 ( 37.58 to 51.75 )
Gender [units: participants]
Female	13	8	21
Male	6	10	16

[1]	Statistics for the total value were not available. The cited numbers are the results of manual calculations.

Outcome Measures

1. Primary:

PC20 AMP (Post-treatment Compared to Baseline) [ Time Frame: Baseline and 5 weeks ]

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2. Secondary:

Δ (FVC/SVC) at PC20 (AMP) [ Time Frame: Baseline and 5 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

Safety and Tolerability [ Time Frame: 5 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Respiratory Medical Advisor
Organization: Nycomed GmbH
phone: 0049-7531-840
e-mail: clinicaltrials@nycomed.com

No publications provided by ALTANA Pharma

Publications automatically indexed to this study:

Cohen J, Postma DS, Douma WR, Vonk JM, De Boer AH, ten Hacken NH. Particle size matters: diagnostics and treatment of small airways involvement in asthma. Eur Respir J. 2011 Mar;37(3):532-40. Epub 2010 Jul 1.

Responsible Party:	Nycomed GmbH, Nycomed
ClinicalTrials.gov Identifier:	NCT00306163 History of Changes
Other Study ID Numbers:	BY9010/NL-101
Study First Received:	March 22, 2006
Results First Received:	April 6, 2010
Last Updated:	April 6, 2010
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)