Efficacy, Safety & Tolerability of Ciclesonide 200mcg Spray 4 Weeks Treatment for Intermittent & Persistent Rhinitis

NCT01369563 | Completed DMC

• 2 other identifiers: MX028U1111-1133-6326
• Study Type: observational
• Target: 1,630
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the efficacy, safety and tolerability of ciclesonide 200 mcg once daily, applied as a nasal spray for four weeks. The main outcome will be the improvement on global and individual typical and associated symptoms of intermittent or persistent rhinitis.

Conditions

Perennial Rhinitis; Seasonal Rhinitis

Keywords

rhinitis; ciclesonide; intermittent rhinitis; persistent rhinitis

Outcome Measures

Primary Outcomes (1)

• Comparison symptoms´ score between initial score day 1 (V-0) vs. day 28 ± 2 (V-1). With a 7-point Likert scale.

  The main outcome will be the described symptoms´ score and will be analyzed by comparison of the initial symptom score day 1 (V-0) vs. day 30 ± 2 (V-1). This is a quasi quantitative variable with a 7-point Likert scale.

  4 weeks

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Male or female external patients over 18 years and under 50 years with active rhinitis (anterior or posterior rhinorrhea, sneezing, nasal congestion and itching) persistent (≥ 4 days a week for 4 consecutive weeks) or intermittent (\<4 days a week for ≤ 4 consecutive weeks), with medical history of rhinitis 2 years prior to their participation in this study and whose nasal symptoms have been severe enough to require continuous or intermittent treatment (it requires a patient's symptoms need treatment at least for a 4 weeks period). All patients have to sign the informed consent or give verbal confirmation prior to their inclusion in the study.

You may qualify if:

• Outpatient (external) male or female over 18 years and under 50 years.
• Patients with active rhinitis (anterior or posterior rhinorrhea, sneezing, nasal congestion and itching) persistent (≥ 4 days a week for 4 consecutive weeks) or intermittent (\< 4 days a week for ≤ 4 consecutive weeks).
• Patient with medical history of rhinitis 2 years prior to their participation in this study and whose nasal symptoms have been severe enough to require continuous or intermittent treatment (it requires a patient's symptoms need treatment at least for a 4 weeks period).
• Patient with the ability to understand the risks and benefits requirement while participating in the study and is able to accomplish the study treatment and with filling questionnaires and patient's diaries.

You may not qualify if:

• Patient with other nasal disease including: nasal polyps or nasal trauma recent.
• Patient with intranasal malformations (cysts and fistulas of the nose dorsum, prenasal space malformation, midline dystrophy, arrhinea, abnormalities of the tear ducts), or other conditions such as; recent nasal biopsy, drug rhinitis.
• Non-controlled asthma or who were under systemic corticosteroid treatment.
• Patient with Chronic Obstructive Pulmonary Disease.
• Patient receiving antibiotic therapy for any acute illness during the past 14 days.
• Patient vaccinated against pneumococcus, H1N1 \& seasonal influenza (past 30 days).
• Patient required initiation or dose escalation immunotherapy. Immunotherapy is permitted if started 90 days ago and the patient received a stable dose during the last 30 days.
• Patient has participated in another research study within 30 days preceding this visit.
• Patient with medical history of hypersensitivity to steroids or any excipients of this class of drugs.
• Treatment with systemic corticosteroids for a chronic or intermittent disorder (e.g., dermatitis) during the last six months or can present a condition that requires them.
• Medical history of alcoholism and/or drug abuse in the last 2 years.
• Medical history or positive testing for HIV, hepatitis B or C.
• The patient uses any of drugs listed in the list on page 5 Table.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Yasmín Crespo

Naucalpan, State of Mexico, 53519, Mexico

Location

MeSH Terms

Conditions

Rhinitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2011
• First Posted: June 9, 2011
• Study Start: August 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: December 5, 2016

Record last verified: 2016-09

Locations

ME (1)