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Respiratory Tract DiseasesPhase 3NCT00254956

Effects Of Ciclesonide And Beclomethasone On Lens Opacification In Adult Subjects With Moderate To Severe Persistent Asthma

A Phase 3 study testing ciclesonide (XRP1526) in people with Respiratory Tract Diseases and Respiratory Hypersensitivity, run by Sanofi at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective is to demonstrate the non-inferiority of ciclesonide compared to beclomethasone-HFA in the occurrence of Class 1 lens event for nuclear (NO), cortical (C), or posterior subcapsular (P) lens opacification within 12 months. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ciclesonide (XRP1526)
How many people
1,568 participants
Where
1 siteFrance
Study dates
Jan 2004to Jun 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or non-pregnant, non-lactating females 18 years of age and older with a history of moderate to severe persistent asthma for a duration of at least 2 months prior to screening.
  • At screening, FEV1 must be ≥ 40% and ≤ 85% of predicted.
  • Documented use of inhaled corticosteroid therapy at any dose for at least 1 month prior to screening.
  • Able to demonstrate acceptable oral inhaler technique.
  • Non-smoker for at least the past year and less than a 10 pack-year smoking history if previous smoker.
  • Written informed consent agreement.

Who cannot join

  • History of prior cataract surgery in either eye.
  • Evidence of congenital cortical cataract.
  • Inability to grade nuclear, cortical, or posterior subcapsular opacities in either eye with LOCS III at the baseline slit lamp examination.
  • Inability to dilate pupils to at least 6.0 mm.
  • Nuclear opalescence with a LOCS III grade ≥ 4 in either eye at the baseline slit lamp examination.
  • Cortical lens opacities with a LOCS III grade ≥ 3 in either eye at the baseline slit lamp examination.
Show all 22Show fewer
  • Posterior subcapsular lens opacities with a LOCS III grade ≥ 2 in either eye at the baseline slit lamp examination.
  • Elevated intraocular pressure requiring treatment
  • Best corrected visual acuity less than 74 letters (equivalent to vision worse than 20/30) in either eye at baseline.
  • Females who are pregnant or lactating or have a positive pregnancy test at Visit 1 (Screening).
  • Have had more than 1 in-patient hospitalization in the past year for asthma exacerbations.
  • Have had more than 2 bursts of oral steroids per year for each of the past 2 years prior to screening.
  • Chronic use of oral, injectable, or topical steroids except for inhaled corticosteroids for any condition. Topical corticosteroids designated as having a mild potency by the Stoughton-Cornell Scale or the European Guideline for levels of corticosteroid activity are allowed (see AppendixG).
  • Any chronic condition that is likely to require treatment with oral or systemic corticosteroids other than asthma (e.g. systemic lupus, inflammatory bowel disease, rheumatoid arthritis).
  • Topical ocular steroid treatment within 3 months prior to screening.
  • Chronic or recurrent inflammatory disease in either eye likely to result in visual abnormalities or require treatment with ocular steroids.
  • History of drug or alcohol abuse.
  • Any clinically significant medical condition that would interfere with the subject's ability to participate in and comply with study protocol.
  • Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
  • Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
  • Hypersensitivity to the investigational products or to drugs with similar chemical structures.
  • Have been treated with any investigational drug/product within 30 days prior to Visit 1 (Screening).

Trial locations and contacts

1 site in 1 country.

France1 site

  • Sanofi-Aventis

    Chilly-Mazarin, 91380

Other trials in France

About this study

Official title: A Multi-Center, Multinational, Randomized, Double-Blind, Parallel Group Study of the Effects of Ciclesonide Hfa-Mdi 640 μg/Day and Beclomethasone Hfa-Mdi 640 μg/Day on Lens Opacification in Adult Subjects With Moderate to Severe Persistent Asthma

The primary objective is to demonstrate the non-inferiority of ciclesonide compared to beclomethasone-HFA in the occurrence of Class 1 lens event for nuclear (NO), cortical (C), or posterior subcapsular (P) lens opacification within 12 months. Secondary objectives are to compare ciclesonide and beclomethasone with respect to class II and class III best corrected visual acuity and intraocular pressure from baseline to 12 months.

Read the detailed description

This is a multi-center, multinational, active-controlled, double-blind, randomized (1:1) parallel group study of the effects of inhaled ciclesonide HFA-MDI 640 mcg/day and beclomethasone HFA-MDI 640 mcg/day on lens opacification in adult subjects with moderate to severe persistent asthma. The study consists of a 1-14 day screening phase during which subject eligibility will be determined, followed by a 12-month double-blind treatment phase. Lens opacification will be evaluated by slit lamp examination performed after pupillary dilation to at least 6.0 mm before randomization and after 4 months, 8 months, and 12 months of treatment using the LOCS III system for grading lens opacities. Best-corrected visual acuity and intraocular pressure will be measured at each eye examination visit. An Independent Data Monitoring Committee (IDMC) will be constituted to monitor safety throughout the double-blind treatment phase.

Being tested
ciclesonide (XRP1526)
Keywords
Diseases, respiratory tract diseases, respiratory hypersensitivity, asthma
Medical subject headings
Respiratory Tract Diseases, Respiratory Hypersensitivity, Asthma, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ciclesonide (XRP1526)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary endpoint is the occurrence of a Class I lens event for nuclear (NO), cortical (C), or posterior subcapsular (P) lens opacification within 12 months.

  2. A Class I lens event is defined as any of the following events in either eye:

  3. - 1.Increase from baseline in LOCS III grade of ≥ 0.5 (NO), ≥ 0.8 (C), or ≥ 0.5 (P)

  4. - 2.Cataract surgery

Secondary outcomes (7)

  1. - 1.Change from baseline to Month 12 in LOCS III grade for (a) nuclear opalescence, (b) cortical opacity, and (c) posterior subcapsular opacity.

  2. - 2.Occurrence within 12 months in either eye of a Class II lens event: Increase from baseline in LOCS III grade of ≥ 0.9 (NO), ≥ 1.5 (C), or ≥ 0.9 (P), or cataract surgery.

  3. - 3.Occurrence within 12 months in either eye of a Class III lens event: LOCS III grade ≥ 2.0 for any type of opacity (NO, C, or P) and a change in LOCS III grade of ≥ 0.9 for NO, ≥ 1.5 for C, and ≥ 0.9 for P, or cataract surgery.

  4. - 4.Change from baseline to Month 12 in best-corrected visual acuity.

  5. - 5.Change from baseline to Month 12 in intraocular pressure (mm Hg).

  6. Tertiary endpoint:

  7. - Change in post-bronchodilator FEV1 from baseline to Month 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2005 (estimated)
  2. Study startJan 2004
  3. Primary completionJun 2005
  4. Study completionJun 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,568 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00254956
Sponsor's protocol ID
SFY6160
Status last verified
Apr 2009
First submitted
15 Nov 2005
Last updated
8 Apr 2009
Results posted
No

Publications

  • Chylack LT Jr, Gross GN, Pedinoff A; Ciclesonide Lenticular Safety Study Group. A randomized, controlled trial to investigate the effect of ciclesonide and beclomethasone dipropionate on eye lens opacity. J Asthma. 2008 Dec;45(10):893-902. doi: 10.1080/02770900802353636.

    PubMed 19085579

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ciclesonide (XRP1526) in people with Respiratory Tract Diseases and Respiratory Hypersensitivity, run by Sanofi at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary endpoint is the occurrence of a Class I lens event for nuclear (NO), cortical (C), or posterior subcapsular (P) lens opacification within 12 months.. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00254956, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2009.

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