Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diphenhydramine + Pseudoephedrine + Dropropizine in the Control of Cough and the Relief of Nasal Symptoms, Suffering From Non-productive Cough and Acute Rhinitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Ache Laboratorios Farmaceuticos S.A..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier:
NCT01199497
First received: September 9, 2010
Last updated: May 3, 2011
Last verified: May 2011
  Purpose

Multicenter clinical trial, phase III, controlled by active medicine, double-blind, randomized, enroll 208 subjects, above 12 years old, that suffer acute inflammation upper airway characterized by non-productive cough, daytime/nighttime, with duration for at least 3 and no more than 5 consecutive days (without systemic/topic use of medication during this period) followed by nasal congestion, with or without associate other nasal symptoms (sneezing, runny nose, nasal itching and/or mouth breathing). The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.


Condition Intervention Phase
Nasal Congestion
Cough
Drug: Group 1
Drug: Group 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Clinical Trial Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diphenhydramine + Pseudoephedrine + Dropropizine in the Control of Cough and the Relief of Nasal Symptoms in Subjects Above 12 Years of Age, Suffering From Non-productive Cough and Acute Rhinitis.

Resource links provided by NLM:


Further study details as provided by Ache Laboratorios Farmaceuticos S.A.:

Primary Outcome Measures:
  • Primary efficacy criteria [ Time Frame: baseline and week 24 ] [ Designated as safety issue: No ]
    The changes of lung function parameter: pre-bronchodilator forced expiratory volume in first second (FEV1) including baseline and 24th week.


Secondary Outcome Measures:
  • Secondary efficacy criteria [ Time Frame: baseline, week 8, 16 and 24 ] [ Designated as safety issue: No ]
    Changes in forced expiratory volume in first second (FEV1).


Estimated Enrollment: 208
Study Start Date: August 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).
Drug: Group 1
fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).
Placebo Comparator: Group 2
Placebo
Drug: Group 2
placebo

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients over 12 years old, of both sexes;
  2. Clinical condition compatible with acute rhinitis accompanied by nasal congestion;
  3. Non-productive cough, daytime and/or nighttime with at least 3 and up 5 consecutive days in duration;
  4. Score greater than or equal to 3 points on the cough severity score (As per item 4.1.2);
  5. Score greater than or equal to 2 points on the nasal congestion severity score (As per item 4.1.3);
  6. If necessary, ICF signed by a parent/representant, or in case the patient over 18 years old, his own signature;
  7. Patient and/or representant capacity, according to investigator evaluation, for compliance at the treatment and protocol requirements, fulfilling the regular visits;

Exclusion Criteria:

  1. Non-productive cough with purulent smear, fever (axilar temperature superior than 37,8°C/100°F), purulent runny nose and other signs and symptoms of bacteria infection of upper and lower airways at 7 days before the screening/randomization visit;
  2. Septal deviation level III (in any region and any nasal cavity) and/or nasal polyps or other determinants conditions of nasal congestion;
  3. Previous diagnosis of asthma;
  4. Female patients with positive b-HCG;
  5. Patients under treatment for chronic allergy;
  6. Presence of purulent or mucupurulent secretion, nasal vault or mal formations (cleft lip or cleft nasolabial corrected or not) in nasal vestibule;
  7. Current use of systemic antibiotics for any reason;
  8. Use of prohibited medicine within the prescribed period before V0 as shown in item 9.3 of this protocol;
  9. Participation in last one year of clinical protocols;
  10. Any psychiatric diseases, including major depression;
  11. Presence of mental retardation from any cause;
  12. Diagnosis of renal or hepatic failure;
  13. History of hypersensitivity to any component of the study drugs;
  14. Relatives of sponsor´s or study site´s employee;
  15. Current evidence of clinically significant diseases: hematopoietic, gastrointestinal, cardiovascular, hepatic, renal, neurological, endocrine, psychiatric, autoimmune, pulmonary, or another disease that block the patient participation;
  16. Patient or parent/representant with a history of lack of compliance to treatment or previous treatment protocols;
  17. Any finding of clinical observation (anamnesis and physical exam) laboratory abnormality (eg, blood glucose, blood count), disease (for example, liver, cardiovascular system, lung) or therapy that, in opinion of the investigator, may endanger the patient or interfere with the endpoints of study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199497

Contacts
Contact: Carla Peron, Md 55 11 2608-8680 carla.peron@ache.com.br

Sponsors and Collaborators
Ache Laboratorios Farmaceuticos S.A.
  More Information

No publications provided

Responsible Party: Carla Rosana Goulart Silva Peron, MD, Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier: NCT01199497     History of Changes
Other Study ID Numbers: ACH-NTS-03(08/10)
Study First Received: September 9, 2010
Last Updated: May 3, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Ache Laboratorios Farmaceuticos S.A.:
cough, acute rhinitis, nasal congestion, common cold, nasal symptoms, children.
Nasal congestion and non-productive cough, with or without associate other nasal and extranasal symptoms.

Additional relevant MeSH terms:
Common Cold
Cough
Rhinitis
Stress, Psychological
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Nose Diseases
Otorhinolaryngologic Diseases
Behavioral Symptoms
Diphenhydramine
Promethazine
Pseudoephedrine
Ephedrine
Dipropizine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antiemetics

ClinicalTrials.gov processed this record on July 31, 2014