Effect of High Dose Ciclesonide on Asthma Control

NCT01455194 | Completed Phase 3 Results

• 4 other identifiers: CL-9709-301-RD2011-000683-99U1111-1133-6333CL-9709-301-RDCTID
• Study Type: interventional
• Target: 520
• Locations: 5 countries
• Sites: 30

Brief Summary

The aim of the trial is to investigate asthma control with 160 to 640 mcg ciclesonide/day. Asthma control will be assessed by the Asthma Control Questionnaire (ACQ).

Conditions

Bronchial Asthma

Keywords

ciclesonide; asthma

Outcome Measures

Primary Outcomes (2)

• Asthma Control Questionnaire (ACQ) Score at Baseline

  The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma.

  Baseline

• Change From Baseline in ACQ Score to Tlast

  The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma.

  Week 52

Secondary Outcomes (12)

• Time Course of ACQ

  Baseline, Week 52 (Treatment period)

• Number of Weeks With Well-controlled Asthma Over the Course of the Study

  Baseline up to Week 52 (treatment period)

• Number of Participants With Well-controlled Asthma and ACQ Improvement at the End of the Study

  Week 52

• Number of Participants Reporting Time to First Well-Controlled Asthma and ACQ Improvement

  Baseline up to Week 52 (treatment period)

• Number of Participants Reporting Time to First Well-Controlled Asthma Measurement by ACQ Cut-Off Point

  Baseline up to Week 52 (treatment period)

Study Arms (3)

CIC 160

ACTIVE COMPARATOR

Two puffs of 40 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 160 mcg)

Drug: Ciclesonide

CIC 320

ACTIVE COMPARATOR

Two puffs of 80 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 320 mcg)

Drug: Ciclesonide

CIC 640

ACTIVE COMPARATOR

Two puffs of 160 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 640 mcg)

Drug: Ciclesonide

Interventions

Ciclesonide DRUG

During the treatment period subjects will inhale two puffs of either 40, 80 or 160 μg ciclesonide in the morning and the evening (corresponding to a total daily dose of 160, 320 or 640 μg)

CIC 160; CIC 320; CIC 640

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent was provided
• History of persistent bronchial asthma for at least 6 months
• Current treatment with an Inhaled Corticosteroid (ICS) at a stable dose in the dose range of 200-1000 μg Fluticasone Propionate (FP)/day or equivalent for a minimum of 12 weeks
• Good inhalation technique
• Under the current ICS pre-treatment the ACQ score ranges between ≥ 0.75 and ≥ 2

You may not qualify if:

• Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
• Concomitant severe diseases (e.g. malignant diseases during the past 5 years \[other than basal or squamous cell carcinoma\], hepatitis C, acquired immune deficiency syndrome \[AIDS\])
• Diseases which are contraindications for the use of ICS (e.g. active or inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment)
• Use of systemic glucocorticosteroids within 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (30)

Unknown Facility

Buenos Aires, Argentina

Location

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Capital Federal, Buenos Aires, Argentina

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Rosario, Argentina

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Rosario-Santa Fe, Argentina

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Salta, Argentina

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San Miguel de Tucumán, Argentina

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Florianópolis, Brazil

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Goiânia, Brazil

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Porto Alegre, Brazil

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Rio de Janiero, Brazil

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Santo André, Brazil

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São Paulo, Brazil

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Sorocaba, Brazil

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Berlin, Germany

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Bonn, Germany

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Landsberg, Germany

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Rüdersdorf, Germany

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Schwetzingen, Germany

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Beersheba, Israel

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Haifa, Israel

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Jerusalem, Israel

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Kfar Saba, Israel

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Petah Tikva, Israel

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Rehovot, Israel

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Tel Aviv, Israel

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Barnaul, Russia

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Moscow, Russia

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Novosibirsk, Russia

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Saint Petersburg, Russia

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Tomsk, Russia

Location

MeSH Terms

Conditions

Asthma

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: AstraZeneca Clinical Study Information Center
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2011
• First Posted: October 19, 2011
• Study Start: November 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 10, 2017
• Results First Posted: October 25, 2016

Record last verified: 2016-12

Locations

BR (7); RU (5); AR (6); DE (5); IL (7)