AsthmaPhase 4NCT00442351
Efficacy and Tolerability of Maintenance Treatment With Asmanex Twisthaler Versus Placebo in Mild/Moderate Persistent Asthmatics (Study P04654)(TERMINATED)
A Phase 4 study testing Asmanex twisthaler in people with Asthma, run by Organon and Co.
Trial summary
This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group study evaluating Asmanex Twisthaler 220 mcg once daily (QD) in the evening (PM) compared with "Asmanex" Placebo QD PM for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Asmanex twisthaler
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Apr 2007
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign informed consent
- Be 18-75 years of age, of either sex and any race
- Have asthma for >= 12 months
- Have mild or moderate persistent asthma
- Prior to completing Screening Visit procedures, must be using: low or moderate doses of an inhaled corticosteroid (IC), with a short-acting beta-2 agonist (SABA) as needed (prn) or a SABA prn as monotherapy. Those using a combination ICs plus long-acting beta-2 agonist (LABA) medication, such as Advair 100/50 twice daily (BID), must be changed to fluticasone propionate 100 mcg BID for at least 5 days prior to the start of Run-In-Period. Those using LABA as monotherapy must be switched to SABA prn for at least 5 days prior to the start of Run-In Period
- Be off treatment with leukotriene receptor antagonist (LTRA) for at least 14 days prior to Screening
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- Have an FEV1 >=65% but <=85% of predicted normal value at Screening and at Baseline when SABAs have been withheld for at least 6 hours
- Demonstrate an increase of absolute FEV1 of >= 12% with an absolute volume increase of at least 200mL during Screening. Written documentation of FEV1 reversibility of >= 12% within 2 years prior to Screening was acceptable in lieu of testing. FEV1 reversibility testing should be done after withholding inhaled SABA for at least 6 hours
- Have a frequency of asthma score of at least 2 (at least 2 symptoms) and/or frequency of bronchodilator use score of at least 2 at Screening
- Have a Total Asthma Severity Score (TASS) of at least 4 on 8 or more of the AM and PM recordings from the last 7 days during the Run-in period prior to Baseline and the AM of the Baseline Visit
- At Screening Visit, have sleep disturbance and scores of >=2 on the interference with sleep rating scale (recall over the past 7 nights), and at least 30 on the Medical Outcomes Study Sleep scale (MOS-SS) Sleep Disturbance Sleep Scale (recall over the past 7 days)
- At the Baseline Visit, must have sleep disturbance and scores of >= 2 on interference with sleep rating scale (recorded in a diary during the past 7 nights), and at least 30 on the MOS-SS Sleep Problems Index II 9 items(SLP 9)
Who cannot join
- Women who are pregnant or intend to become pregnant during the study
- Women who are nursing or intend to nurse during the study or within 30 days after completion
- Have participated in any clinical trial within the last 30 days or in one involving antibodies for asthma or rhinitis within 3 months prior to Screening
- Have had an unscheduled medical visit (due to exacerbation of asthma) within 1 month prior to Screening
- Have been treated in the emergency room or admitted to the hospital due to exacerbation of asthma on two or more occasions within the 12 months prior to Screening
- Have used >12 puffs of rescue SABAs or 2 treatments with a nebulized beta-2-agonist per day on 2 consecutive days within 4 weeks prior to Screening
Show all 14Show fewer
- Required more than 2 courses of oral/systemic corticosteroids for asthma within 12 months prior to Screening
- Have a history of sleep disorders, including narcolepsy, or use of medications that affect alertness or sleep
- Have sleep apnea, obstructive sleep apnea-hypopnea, or are being treated with the ventilation devices Continuous Positive Airway Pressure (CPAP) or (Bi-level Positive Airway Pressure (Bi-PAP), or are receiving oxygen by inhalation
- Are smokers or ex-smokers who have smoked within 6 months prior to
- Screening or have a cumulative smoking history of 10 pack-years or greater
- Are allergic to corticosteroids, SABAs, or LABAs
- Required ventilator support for respiratory failure secondary to asthma in the last 10 years
- Have a Body-Mass-Index greater than 35
About this study
Official title: A Comparative Study of The Efficacy and Tolerability of Maintenance Treatment of Patients With Mild/Moderate Persistent Asthma With Asmanex Twisthaler 220 mcg QD PM Versus "Asmanex" Placebo QD PM
This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group study evaluating Asmanex Twisthaler 220 mcg once daily (QD) in the evening (PM) compared with "Asmanex" Placebo QD PM for 12 weeks. Efficacy will be measured for the changes in forced expiratory volume in 1 second (FEV1) from baseline to the end of treatment period (Week 12 or end of the study).
- Conditions
- Asthma
- Being tested
- Asmanex twisthaler, Placebo for Asmanex twisthaler
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asmanex twisthalerDrug
Also called Mometasone furoate inhalation powder
Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
Placebo for Asmanex twisthalerOther
Placebo for Asmanex Twisthaler 220 mcg, once daily in the evening for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Asmanex Twisthaler | Experimental | Not described Receives: Drug: Asmanex twisthaler |
| Placebo inhaler | Placebo comparator | Not described Receives: Other: Placebo for Asmanex twisthaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Final/Terminal Visit in Forced Expiratory Value in 1 Second (FEV1) in Morning Office Measurements.
The baseline value for this outcome measure was evaluated at the baseline visit prior to randomization. The change from Baseline to final/terminal visit in FEV1 was to be analyzed using an Analysis of Covariance (ANCOVA) model.
Measured: Twelve (12) weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startSep 2006
- Primary completionApr 2007
- Study completionApr 2007
Why it stopped: Slow Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442351
- Sponsor's protocol ID
- P04654
- Other IDs
- IND Number: 46216; SCH 032088
- Status last verified
- Feb 2022
- First submitted
- 28 Feb 2007
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of The Efficacy and Tolerability of Maintenance Treatment of Patients With Mild/Moderate Persistent Asthma With Asmanex Twisthaler 220 mcg QD PM Versus "Asmanex" Placebo QD PM
- ClinicalTrials.gov ID
- NCT00442351
- Acronym / sponsor ID
- P04654
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Enrollment
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 1 Mar 2007 (estimated)
- Results
- Posted 16 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group study evaluating Asmanex Twisthaler 220 mcg once daily (QD) in the evening (PM) compared with "Asmanex" Placebo QD PM for 12 weeks. Efficacy will be measured for the changes in forced expiratory volume in 1 second (FEV1) from baseline to the end of treatment period (Week 12 or end of the study).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asmanex Twisthaler | Experimental | Drug: Asmanex twisthaler |
| Placebo inhaler | Placebo comparator | Other: Placebo for Asmanex twisthaler |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Sign informed consent
- Be 18-75 years of age, of either sex and any race
- Have asthma for >= 12 months
- Have mild or moderate persistent asthma
- Prior to completing Screening Visit procedures, must be using: low or moderate doses of an inhaled corticosteroid (IC), with a short-acting beta-2 agonist (SABA) as needed (prn) or a SABA prn as monotherapy. Those using a combination ICs plus long-acting beta-2 agonist (LABA) medication, such as Advair 100/50 twice daily (BID), must be changed to fluticasone propionate 100 mcg BID for at least 5 days prior to the start of Run-In-Period. Those using LABA as monotherapy must be switched to SABA prn for at least 5 days prior to the start of Run-In Period
Key exclusion criteria (14 listed)
- Women who are pregnant or intend to become pregnant during the study
- Women who are nursing or intend to nurse during the study or within 30 days after completion
- Have participated in any clinical trial within the last 30 days or in one involving antibodies for asthma or rhinitis within 3 months prior to Screening
- Have had an unscheduled medical visit (due to exacerbation of asthma) within 1 month prior to Screening
- Have been treated in the emergency room or admitted to the hospital due to exacerbation of asthma on two or more occasions within the 12 months prior to Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asmanex twisthalerAlso: Mometasone furoate inhalation powderAsmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks | Drug | Asmanex Twisthaler |
| Placebo for Asmanex twisthalerPlacebo for Asmanex Twisthaler 220 mcg, once daily in the evening for 12 weeks | Other | Placebo inhaler |
Primary outcome
Change From Baseline to Final/Terminal Visit in Forced Expiratory Value in 1 Second (FEV1) in Morning Office Measurements.
Time frame: Twelve (12) weeks
The baseline value for this outcome measure was evaluated at the baseline visit prior to randomization. The change from Baseline to final/terminal visit in FEV1 was to be analyzed using an Analysis of Covariance (ANCOVA) model.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Asmanex twisthaler in people with Asthma, run by Organon and Co.
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 12 inclusion and 14 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: stopped early, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline to Final/Terminal Visit in Forced Expiratory Value in 1 Second (FEV1) in Morning Office Measurements. (time frame: Twelve (12) weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2022.