SAFETY AND EFFICACY STUDY OF QVM149 IN ASTHMATIC PATIENTS

Not Applicable

• Conditions: -J45; J45

• Registration Number: PER-024-16
• Lead Sponsor: OVARTIS BIOSCIENSES PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-15
• Study Completion: 2019-05-17
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Male and female adult patient ≥ 18 years old and ≤ 75 years.
2. Written informed consent must be obtained before any studyrelated
assessment is performed.
3. Patients with a diagnosis of asthma, (GINA 2015 ≥ step 4) for a
period of at least 1 year prior to Visit 1 (Screening).
4. Patients who have used ICS/LABA combinations (Appendix
10) for asthma for at least 1 year and at stable medium or high
doses of ICS/LABA for at least 1 month prior to Visit 1. 5. Patients must be symptomatic at screening despite treatment
with mid or high stable doses of ICS/LABA. Patients with
ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (randomization
visit) (GINA 2015 step≥ 4).
6. Patients with documented history of at least one asthma
exacerbation which required medical care from a physician, ER
visit (or local equivalent structure) or hospitalization in the 12
months prior to Visit 1 and required systemic corticosteroid
treatment.
Previous asthma exacerbation in this context is based on
patient´s recall of unplanned need for medical care at any
primary care physician, pulmonologist, emergency room and/or
hospital due to an aggravation of asthma symptoms requiring
treatment with systemic corticosteroids due to asthma
exacerbation. Every effort should be made by the site to
obtain/have appropriate source documentation for these
previous asthma exacerbations.
7. Pre-bronchodilator FEV1 of < 80 % of the predicted normal
value for the patient after withholding bronchodilators (Table 5-
2) at both visits 101 and 102.
 Withholding period of bronchodilators prior to spirometry:
SABA for ≥ 6 hrs.
LABA (or fixed dose combination of ICS/LABA) for ≥ 24 hrs
(48 hrs for indacaterol fixed dose combination (FDC)), SAMA
for ≥ 8 hrs, xanthines ≥ 7 days.
 Re-testing is allowed once only. Re-assessment of
percentage predicted FEV1 should be done in an ad-hoc
visit to be scheduled on a date that would provide sufficient
time to receive confirmation from the spirometry data
central reviewer of the validity of the assessment before
randomization.
Spacer devices are not permitted during reversibility testing.

Exclusion Criteria

 Patients who have had an asthma attack/exacerbation requiring
systemic steroids or hospitalization or emergency room visit
within 6 weeks of Visit 1 (Screening).
 Patients who have ever required intubation for a severe asthma
attack/exacerbation
 Patients who have a clinical condition which is likely to be
worsened by ICS administration (e.g. glaucoma, cataract and
fragility fractures) who are according to investigator´s medical
judgment at risk participating in the study)
 Patients treated with a LAMA for asthma within 12 months
prior Visit 1 (Screening).
 Patients with narrow-angle glaucoma, symptomatic benign
prostatic hyperplasia (BPH) or bladder-neck obstruction or
severe renal impairment or urinary retention. BPH patients who
are stable on treatment can be considered).
 Patients who have had a respiratory tract infection or asthma
worsening according to the definition in Section 6.4.4 within 4
weeks prior to Visit 1 (Screening) or between Visit 1 and Visit
102. Patients may be re-screened 4 weeks after recovery from
their respiratory tract infection or asthma worsening
 Patients with a history of chronic lung diseases other than
asthma, including (but not limited to) COPD, sarcoidosis,
interstitial lung disease, cystic fibrosis, clinically significant
bronchiectasis and active tuberculosis
 Patients with narcolepsy and/or insomnia
 Patients on Maintenance Immunotherapy (desensitization) for
allergies or less than 3 months prior to Visit 101 or patients on
Maintenance Immunotherapy for more than 3 months prior to
Visit 101 but expected to change throughout the course of the
study

Study & Design

• Study Type: Interventional
• Study Design: Not specified